<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/NCT04490304</url>
  </required_header>
  <id_info>
    <org_study_id>2018/252</org_study_id>
    <nct_id>NCT04490304</nct_id>
  </id_info>
  <brief_title>The Analysis of Posterior Soft Tissue Repair Durability</brief_title>
  <official_title>How Durable is the Posterior Soft Tissue Repair After Total Hip Arthroplasty in Primary Osteoarthiritis Patients?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dislocation after THA usually occurs early after surgery and some go on to disabling&#xD;
      recurrent dislocations . The posterior surgical approach is frequently used since it provides&#xD;
      excellent exposure of both acetabulum and femur. However, many series on primary THA have&#xD;
      reported that dislocation is 2 to 3 times more frequent after the posterior approach as&#xD;
      compared to other approaches . Dissatisfaction with these dislocation rates resulted in the&#xD;
      introduction of different posterior soft tissue repair techniques. Many authors have reported&#xD;
      statistically significant differences in dislocation rates with posterior soft tissue repair&#xD;
      as compared to without . However, there is still a concern in the literature regarding the&#xD;
      durability of posterior soft tissue repair.&#xD;
&#xD;
      The aim of our study was to analyse THA patients with posterior soft tissue repair in terms&#xD;
      of suture durability of two different suture materials and time of suture failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 42 consecutive THA patients (20 women,22 men) operated for primary osteoarthritis&#xD;
      (OA) between 2018 and 2019 were included in the study. All patients were operated by the same&#xD;
      orthopaedic surgeon under spinal anaesthesia via posterior approach using the same type of&#xD;
      uncemented Polar stem(Smith and Nephew Inc) with 36 mm head in combination with uncemented&#xD;
      Ep-Fit acetabular cup (Smith and Nephew Inc). All the patients were randomly divided into two&#xD;
      groups. The randomization process was done by the odd and even number technique in which the&#xD;
      patients with even inpatient numbers were assigned in Group A while the odd inpatient number&#xD;
      patients were allotted in Group B. Patients in whom number 5 Ethibond Excel(Ethicon,&#xD;
      Somerville, NJ) were used for soft tissue repair were included in Group A (n=22), whereas&#xD;
      patients treated with number 2 Vicryl (Ethicon, Somerville,NJ)were in Group B (n=20).&#xD;
&#xD;
      The short external rotators tendons were released from the greater trochanter just at their&#xD;
      insertion point. The capsule was incised, but not excised. The posterior repair included&#xD;
      reattaching the piriformis,conjoined tendons and the capsule to the greater trochanter at the&#xD;
      insertion point through 2, 2 mm drill holes with 2 stitches with non-absorbable no.5 Ethibond&#xD;
      suture in one group and with absorbable no 2 vicryl suture in the other group after the&#xD;
      prosthesis had been implanted and the joint reduced. One hemoclip was attached to the&#xD;
      piriformis tendon and another to the conjoined tendons before pulling the sutures out of the&#xD;
      drill holes in the trochanter. The suture materials lateral to the drill holes at the&#xD;
      trochanter were also attached with two hemoclips.(fig 1-2) The postoperative regimen included&#xD;
      walking with full weight bearing the next day after the surgery with a walking frame and&#xD;
      without limitations in internal rotation or flexion. Anteroposterior radiographic examination&#xD;
      was undertaken immediately after the patients returned from the operating theatre to the&#xD;
      intensive care unit,at the 15th day, at 3 months and 6 months postoperatively (figure 3). The&#xD;
      detachment of the hemoclips were measured during the follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2018</start_date>
  <completion_date type="Actual">January 24, 2020</completion_date>
  <primary_completion_date type="Actual">October 16, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>prospective randomised trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>the x-ray measurements after the surgery were done by a care provider, not by the investigator</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>elongation of capsular repair</measure>
    <time_frame>6 months</time_frame>
    <description>measurement of detachment of the sutures after capsular repair</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Arthroplasty Complications</condition>
  <arm_group>
    <arm_group_label>posterior soft tissue repair durability</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>durability of posterior soft tissue repair</intervention_name>
    <description>how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?</description>
    <arm_group_label>posterior soft tissue repair durability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        primary osteoarthritis patients between 40-80 years old undergoing total hip replacement&#xD;
        surgery between 2018-2019&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Any type of secondary osteoarthritis patients, and patients younger than 40 and older than&#xD;
        80 years old.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>41 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>erdem edipoglu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bakirkoy Dr. Sadi Konuk Research and Training Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bakırkoysadikonuk</name>
      <address>
        <city>Istanbul</city>
        <state>Bakırkoy</state>
        <zip>34150</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 29, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>posterior soft tissue repair</keyword>
  <!-- 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/NCT04490304
org study id: 2018/252
nct id: NCT04490304
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Dislocation after THA usually occurs early after surgery and some go on to disabling
      recurrent dislocations . The posterior surgical approach is frequently used since it provides
      excellent exposure of both acetabulum and femur. However, many series on primary THA have
      reported that dislocation is 2 to 3 times more frequent after the posterior approach as
      compared to other approaches . Dissatisfaction with these dislocation rates resulted in the
      introduction of different posterior soft tissue repair techniques. Many authors have reported
      statistically significant differences in dislocation rates with posterior soft tissue repair
      as compared to without . However, there is still a concern in the literature regarding the
      durability of posterior soft tissue repair.

      The aim of our study was to analyse THA patients with posterior soft tissue repair in terms
      of suture durability of two different suture materials and time of suture failure.
A total of 42 consecutive THA patients (20 women,22 men) operated for primary osteoarthritis
      (OA) between 2018 and 2019 were included in the study. All patients were operated by the same
      orthopaedic surgeon under spinal anaesthesia via posterior approach using the same type of
      uncemented Polar stem(Smith and Nephew Inc) with 36 mm head in combination with uncemented
      Ep-Fit acetabular cup (Smith and Nephew Inc). All the patients were randomly divided into two
      groups. The randomization process was done by the odd and even number technique in which the
      patients with even inpatient numbers were assigned in Group A while the odd inpatient number
      patients were allotted in Group B. Patients in whom number 5 Ethibond Excel(Ethicon,
      Somerville, NJ) were used for soft tissue repair were included in Group A (n=22), whereas
      patients treated with number 2 Vicryl (Ethicon, Somerville,NJ)were in Group B (n=20).

      The short external rotators tendons were released from the greater trochanter just at their
      insertion point. The capsule was incised, but not excised. The posterior repair included
      reattaching the piriformis,conjoined tendons and the capsule to the greater trochanter at the
      insertion point through 2, 2 mm drill holes with 2 stitches with non-absorbable no.5 Ethibond
      suture in one group and with absorbable no 2 vicryl suture in the other group after the
      prosthesis had been implanted and the joint reduced. One hemoclip was attached to the
      piriformis tendon and another to the conjoined tendons before pulling the sutures out of the
      drill holes in the trochanter. The suture materials lateral to the drill holes at the
      trochanter were also attached with two hemoclips.(fig 1-2) The postoperative regimen included
      walking with full weight bearing the next day after the surgery with a walking frame and
      without limitations in internal rotation or flexion. Anteroposterior radiographic examination
      was undertaken immediately after the patients returned from the operating theatre to the
      intensive care unit,at the 15th day, at 3 months and 6 months postoperatively (figure 3). The
      detachment of the hemoclips were measured during the follow up period.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: prospective randomised trial
primary purpose: Treatment
masking: None (Open Label)
masking description: the x-ray measurements after the surgery were done by a care provider, not by the investigator
measure: elongation of capsular repair
time frame: 6 months
description: measurement of detachment of the sutures after capsular repair
arm group label: posterior soft tissue repair durability
arm group type: Other
intervention type: Other
intervention name: durability of posterior soft tissue repair
description: how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?
arm group label: posterior soft tissue repair durability
criteria: 
gender: All
minimum age: 41 Years
maximum age: 79 Years
healthy volunteers: No
last name: erdem edipoglu
role: Principal Investigator
affiliation: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
facility: 
country: Turkey
responsible party type: Sponsor