<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04475341</url>
  </required_header>
  <id_info>
    <org_study_id>GK2019OUTBACK</org_study_id>
    <nct_id>NCT04475341</nct_id>
  </id_info>
  <brief_title>Osteochondral Lesions Under 15mm2 of the Talus; is Iliac Crest Bone Marrow Aspirate Concentrate the Key to Success?</brief_title>
  <acronym>OUTBACK</acronym>
  <official_title>'A Randomized Clinical Trial on the Clinical Efficacy of Bone Marrow Stimulation Combined With the Insertion of Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Small Primary and Non-primary Talar Osteochondral Lesions'</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of&#xD;
      patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed&#xD;
      conservative management, surgical intervention may be necessary. For small cystic defects the&#xD;
      current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which&#xD;
      the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order&#xD;
      to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into&#xD;
      the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell&#xD;
      population from the underlying bone marrow. This procedure has been reported to have a 75%&#xD;
      successful long-term outcome. Recently, the additional use of biological adjuncts has become&#xD;
      popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC&#xD;
      consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may&#xD;
      therefore theoretically improve the quality of subchondral plate and cartilage repair. The&#xD;
      current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It&#xD;
      is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in&#xD;
      comparison to BMS alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of&#xD;
      patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed&#xD;
      conservative management, surgical intervention may be necessary. For small cystic defects the&#xD;
      current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which&#xD;
      the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order&#xD;
      to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into&#xD;
      the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell&#xD;
      population from the underlying bone marrow. This procedure has been reported to have a 75%&#xD;
      successful long-term outcome. Recently, the additional use of biological adjuncts has become&#xD;
      popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC&#xD;
      consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may&#xD;
      therefore theoretically improve the quality of subchondral plate and cartilage repair. The&#xD;
      current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It&#xD;
      is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in&#xD;
      comparison to BMS alone.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 2, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale of Pain During Weightbearing</measure>
    <time_frame>2 years post-operatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>EQ5D</measure>
    <time_frame>pre-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ5D</measure>
    <time_frame>three months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ5D</measure>
    <time_frame>one-year post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EQ5D</measure>
    <time_frame>two years post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS</measure>
    <time_frame>preoperatively</time_frame>
    <description>American Orthopaedic Foot and Ankle Score (AOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS</measure>
    <time_frame>three months postoperatively</time_frame>
    <description>American Orthopaedic Foot and Ankle Score (AOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS</measure>
    <time_frame>one-year post-operatively</time_frame>
    <description>American Orthopaedic Foot and Ankle Score (AOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AOFAS</measure>
    <time_frame>two years post-operatively</time_frame>
    <description>American Orthopaedic Foot and Ankle Score (AOFAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Foot and Ankle Outcome Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS</measure>
    <time_frame>three months</time_frame>
    <description>Foot and Ankle Outcome Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS</measure>
    <time_frame>one-year post-operatively</time_frame>
    <description>Foot and Ankle Outcome Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAOS</measure>
    <time_frame>two years post-operatively</time_frame>
    <description>Foot and Ankle Outcome Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS in rest</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS in rest</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS in rest</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS in rest</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during running</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Running</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during running</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Running</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during running</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Running</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during running</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Running</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during stair-climbing</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Stair-Climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during stair-climbing</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Stair-Climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during stair-climbing</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Stair-Climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during stair-climbing</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Stair-Climbing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during performing sports</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Sports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during performing sports</measure>
    <time_frame>3 months post-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Sports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during performing sports</measure>
    <time_frame>1 year post-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Sports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during performing sports</measure>
    <time_frame>2 years post-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Sports</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during weight-bearing</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Numeric Rating Scale of Pain During Weightbearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during weight-bearing</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Numeric Rating Scale of Pain During Weightbearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NRS during weight-bearing</measure>
    <time_frame>1 year post-operativley</time_frame>
    <description>Numeric Rating Scale of Pain During Weightbearing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAAM</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Foot and Ankle Ability Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAAM</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Foot and Ankle Ability Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAAM</measure>
    <time_frame>1 year postoperatively</time_frame>
    <description>Foot and Ankle Ability Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FAAM</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Foot and Ankle Ability Measure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>pre-operatively</time_frame>
    <description>Short-Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Short-Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>1 year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SF-12</measure>
    <time_frame>2 years postoperatively</time_frame>
    <description>Short-Form 12</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Activity Scale (AAS)</measure>
    <time_frame>pre-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Activity Scale (AAS)</measure>
    <time_frame>3 months postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Activity Scale (AAS)</measure>
    <time_frame>1 year post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ankle Activity Scale (AAS)</measure>
    <time_frame>2 year post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to sports</measure>
    <time_frame>post-operatively until 2 years of follow-up post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work</measure>
    <time_frame>post-operatively until 2 years of follow-up post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)</measure>
    <time_frame>pre-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)</measure>
    <time_frame>2 weeks postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)</measure>
    <time_frame>1 year postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)</measure>
    <time_frame>2 years postoperatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: MRI scan (T2 relaxation times)</measure>
    <time_frame>Pre-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: MRI scan (T2 relaxation times)</measure>
    <time_frame>1 year post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological outcomes: MRI scan (T2 relaxation times)</measure>
    <time_frame>2 years post-operatively</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiviness</measure>
    <time_frame>From per-operatively to post-operatively at 2 years (one period)</time_frame>
    <description>all relevant clinical costs will be scored through a patient diary</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cell-subset analysis</measure>
    <time_frame>per-operatively</time_frame>
    <description>protein analyses will be performed by Sanquin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Demographic data</measure>
    <time_frame>Pre-operatively</time_frame>
    <description>all kinds of demographic data will be assessed (age, gender, etc.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>From per-operatively to post-operatively at 2 years (one period)</time_frame>
    <description>all types of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Re-operations</measure>
    <time_frame>From per-operatively to post-operatively at 2 years (one period)</time_frame>
    <description>re-operations will be assessed</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Osteochondral Lesion of Talus</condition>
  <arm_group>
    <arm_group_label>BMS without BMAC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>BMS with BMAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>BMS + Bone Marrow Aspirate Concentrate</intervention_name>
    <description>Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.</description>
    <arm_group_label>BMS with BMAC</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BMS alone</intervention_name>
    <description>Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.</description>
    <arm_group_label>BMS without BMAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a symptomatic OCL of the talus who are scheduled for arthroscopic&#xD;
             debridement and microfracture&#xD;
&#xD;
          -  OCL depth and/or diameter ≤ 15 mm on computed tomography medial-lateral and/or&#xD;
             anterior-posterior&#xD;
&#xD;
          -  Age 18 years or older&#xD;
&#xD;
          -  Intact remaining articular cartilage of the joint Kellgren-Lawrence stage 0-1&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concomitant OCL of the tibia&#xD;
&#xD;
          -  Ankle osteoarthritis grade 2 or 3 van Dijk et al. [53]&#xD;
&#xD;
          -  Ankle fracture &lt; 6 months before scheduled arthroscopy&#xD;
&#xD;
          -  Inflammatory arthropathy (e.g Rheumatoid arthritis)&#xD;
&#xD;
          -  History of (or current) hemopoeitic disease or immunotherapy&#xD;
&#xD;
          -  Acute or chronic instability of the ankle&#xD;
&#xD;
          -  Use of prescribed orthopaedic shoewear&#xD;
&#xD;
          -  Other concomitant painful or disabling disease of the lower limb&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Implanted pacemaker&#xD;
&#xD;
          -  Participation in previous trials &lt; 1 year, in which the subject has been exposed to&#xD;
             radiation (radiographs or CT)&#xD;
&#xD;
          -  Patients who are unable to fill out questionnaires and cannot have them filled out&#xD;
&#xD;
          -  No informed consent&#xD;
&#xD;
          -  HIV positive or hepatitis B or C infection (based on the anamnesis of the patient)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jari Dahmen, MD, BSc</last_name>
    <phone>+31638522988</phone>
    <email>j.dahmen@amsterdamumc.nl</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Jari Dahmen</investigator_full_name>
    <investigator_title>MD, BSc</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04475341
org study id: GK2019OUTBACK
nct id: NCT04475341
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of
      patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed
      conservative management, surgical intervention may be necessary. For small cystic defects the
      current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which
      the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order
      to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into
      the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell
      population from the underlying bone marrow. This procedure has been reported to have a 75%
      successful long-term outcome. Recently, the additional use of biological adjuncts has become
      popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC
      consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may
      therefore theoretically improve the quality of subchondral plate and cartilage repair. The
      current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It
      is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in
      comparison to BMS alone.
Osteochondral defects (OCDs) of the talus have a significant impact on the quality of life of
      patients. When OCDs are of small nature (up to 15 mm in diameter), and have failed
      conservative management, surgical intervention may be necessary. For small cystic defects the
      current treatment is an arthroscopic bone marrow stimulation (BMS) procedure, during which
      the damaged cartilage is resected and the subchondral bone is microfractured (MF), in order
      to disrupt intraosseous blood vessels and thereby introduce blood and bone marrow cells into
      the debrided lesion, forming a microfracture fibrin clot, which contains a dilute stem cell
      population from the underlying bone marrow. This procedure has been reported to have a 75%
      successful long-term outcome. Recently, the additional use of biological adjuncts has become
      popular, one of them being bone marrow aspirate concentrate (BMAC) from the iliac crest. BMAC
      consists of mesenchymal stem cells, hematopoietic stem cells and growth factors, which may
      therefore theoretically improve the quality of subchondral plate and cartilage repair. The
      current evidence for treating talar OCDs with BMS plus BMAC is limited and heterogeneous. It
      is unclear to what extent the treatment of talar OCDs with BMS plus BMAC is beneficial in
      comparison to BMS alone.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Numeric Rating Scale of Pain During Weightbearing
time frame: 2 years post-operatively
measure: EQ5D
time frame: pre-operatively
measure: EQ5D
time frame: three months postoperatively
measure: EQ5D
time frame: one-year post-operatively
measure: EQ5D
time frame: two years post-operatively
measure: AOFAS
time frame: preoperatively
description: American Orthopaedic Foot and Ankle Score (AOFAS)
measure: AOFAS
time frame: three months postoperatively
description: American Orthopaedic Foot and Ankle Score (AOFAS)
measure: AOFAS
time frame: one-year post-operatively
description: American Orthopaedic Foot and Ankle Score (AOFAS)
measure: AOFAS
time frame: two years post-operatively
description: American Orthopaedic Foot and Ankle Score (AOFAS)
measure: FAOS
time frame: pre-operatively
description: Foot and Ankle Outcome Score
measure: FAOS
time frame: three months
description: Foot and Ankle Outcome Score
measure: FAOS
time frame: one-year post-operatively
description: Foot and Ankle Outcome Score
measure: FAOS
time frame: two years post-operatively
description: Foot and Ankle Outcome Score
measure: NRS in rest
time frame: pre-operatively
description: Numeric Rating Scale of Pain During Rest
measure: NRS in rest
time frame: 3 months postoperatively
description: Numeric Rating Scale of Pain During Rest
measure: NRS in rest
time frame: 1 year postoperatively
description: Numeric Rating Scale of Pain During Rest
measure: NRS in rest
time frame: 2 years postoperatively
description: Numeric Rating Scale of Pain During Rest
measure: NRS during running
time frame: pre-operatively
description: Numeric Rating Scale of Pain During Running
measure: NRS during running
time frame: 3 months postoperatively
description: Numeric Rating Scale of Pain During Running
measure: NRS during running
time frame: 1 year postoperatively
description: Numeric Rating Scale of Pain During Running
measure: NRS during running
time frame: 2 years postoperatively
description: Numeric Rating Scale of Pain During Running
measure: NRS during stair-climbing
time frame: pre-operatively
description: Numeric Rating Scale of Pain During Stair-Climbing
measure: NRS during stair-climbing
time frame: 3 months postoperatively
description: Numeric Rating Scale of Pain During Stair-Climbing
measure: NRS during stair-climbing
time frame: 1 year postoperatively
description: Numeric Rating Scale of Pain During Stair-Climbing
measure: NRS during stair-climbing
time frame: 2 years postoperatively
description: Numeric Rating Scale of Pain During Stair-Climbing
measure: NRS during performing sports
time frame: pre-operatively
description: Numeric Rating Scale of Pain During Sports
measure: NRS during performing sports
time frame: 3 months post-operatively
description: Numeric Rating Scale of Pain During Sports
measure: NRS during performing sports
time frame: 1 year post-operatively
description: Numeric Rating Scale of Pain During Sports
measure: NRS during performing sports
time frame: 2 years post-operatively
description: Numeric Rating Scale of Pain During Sports
measure: NRS during weight-bearing
time frame: pre-operatively
description: Numeric Rating Scale of Pain During Weightbearing
measure: NRS during weight-bearing
time frame: 3 months postoperatively
description: Numeric Rating Scale of Pain During Weightbearing
measure: NRS during weight-bearing
time frame: 1 year post-operativley
description: Numeric Rating Scale of Pain During Weightbearing
measure: FAAM
time frame: pre-operatively
description: Foot and Ankle Ability Measure
measure: FAAM
time frame: 3 months postoperatively
description: Foot and Ankle Ability Measure
measure: FAAM
time frame: 1 year postoperatively
description: Foot and Ankle Ability Measure
measure: FAAM
time frame: 2 years postoperatively
description: Foot and Ankle Ability Measure
measure: SF-12
time frame: pre-operatively
description: Short-Form 12
measure: SF-12
time frame: 3 months postoperatively
description: Short-Form 12
measure: SF-12
time frame: 1 year postoperatively
measure: SF-12
time frame: 2 years postoperatively
description: Short-Form 12
measure: Ankle Activity Scale (AAS)
time frame: pre-operatively
measure: Ankle Activity Scale (AAS)
time frame: 3 months postoperatively
measure: Ankle Activity Scale (AAS)
time frame: 1 year post-operatively
measure: Ankle Activity Scale (AAS)
time frame: 2 year post-operatively
measure: Return to sports
time frame: post-operatively until 2 years of follow-up post-operatively
measure: Return to work
time frame: post-operatively until 2 years of follow-up post-operatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
time frame: pre-operatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
time frame: 2 weeks postoperatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
time frame: 1 year postoperatively
measure: Radiological outcomes: CT-scan (depth, wide, length, joint space measurement)
time frame: 2 years postoperatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
time frame: Pre-operatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
time frame: 1 year post-operatively
measure: Radiological outcomes: MRI scan (T2 relaxation times)
time frame: 2 years post-operatively
measure: Cost-effectiviness
time frame: From per-operatively to post-operatively at 2 years (one period)
description: all relevant clinical costs will be scored through a patient diary
measure: Cell-subset analysis
time frame: per-operatively
description: protein analyses will be performed by Sanquin
measure: Demographic data
time frame: Pre-operatively
description: all kinds of demographic data will be assessed (age, gender, etc.)
measure: Complications
time frame: From per-operatively to post-operatively at 2 years (one period)
description: all types of complications
measure: Re-operations
time frame: From per-operatively to post-operatively at 2 years (one period)
description: re-operations will be assessed
arm group label: BMS without BMAC
arm group type: Active Comparator
arm group label: BMS with BMAC
arm group type: Experimental
intervention type: Biological
intervention name: BMS + Bone Marrow Aspirate Concentrate
description: Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
arm group label: BMS with BMAC
intervention type: Procedure
intervention name: BMS alone
description: Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
arm group label: BMS without BMAC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jari Dahmen, MD, BSc
phone: +31638522988
email: j.dahmen@amsterdamumc.nl
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Jari Dahmen
investigator title: MD, BSc
sharing ipd: Undecided