<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/NCT03812237</url>
  </required_header>
  <id_info>
    <org_study_id>OAM-TMT-01</org_study_id>
    <nct_id>NCT03812237</nct_id>
  </id_info>
  <brief_title>Early Weight Bearing Tarsometatarsal Fusion Study</brief_title>
  <official_title>A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing Versus Non-Weight Bearing Following Modified Lapidus Arthrodesis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Orthopaedic Associates of Michigan, PC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grand Rapids Medical Education Partners</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Orthopaedic Associates of Michigan, PC</source>
  <oversight_info>
    <has_dmc>No</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>
      A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight&#xD;
      Bearing Following Modified Lapidus Arthrodesis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this prospective randomized control trial is to assess outcomes in patients&#xD;
      who undergo modified Lapidus arthrodesis and whose postoperative management includes early&#xD;
      weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post&#xD;
      operative management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2012</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">July 1, 2017</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>
    <intervention_model_description>Prospective, Randomized, Controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients were blinded to treatment until their 2 week post-operative visit.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>TMT Fusion Rate</measure>
    <time_frame>6 months</time_frame>
    <description>To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Foot &amp; Ankle Society Midfoot Scores (AOFAS)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.] AOFAS Scale: [0 (no function/severe deformity) to 83 (full function/no limitations/deformity)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Musculoskeletal Function Assessment (SMFA)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 [1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot Function Index Revised (FFIr)</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. FFIr Scale: 67 items scored 1 to 7 [1(no problems/no difficulty/not bothered) - 6 (unable to do a task/symptoms all the time/worst pain imaginable) - 7 (Not applicable)]. Score range: 46 to 230.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form Health Survey (SF-36) v.2</measure>
    <time_frame>12 months</time_frame>
    <description>Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SF-36 v.2 Scale: Self-reporting outcomes assessment [0 (no function/severe physical/mental disability) to 100 (full function, no limitations to mental/physical health)]. Score range: 46 to 230.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">131</enrollment>
  <condition>Hallux Valgus</condition>
  <arm_group>
    <arm_group_label>(EWB) Early Weight Bearing (2 Weeks Post-op)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects in the EWB group were allowed to begin bearing 50 pounds (lbs) through their hindfoot in either the boot or the short leg cast at the two-week visit. They were allowed to advance their weightbearing as tolerated by 25 lbs every four days until full weightbearing through the hindfoot was achieved.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>(SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects in the SOC group were allowed to heel touch weightbear for balance only on the operative foot until the six to eight week visit. At this visit all subjects were placed into a short leg walking boot. Non-weightbearing patients were permitted to begin the progressive weightbearing protocol, without hindfoot restriction.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>(EWB) Early Weight Bearing (2 Weeks Post-op)</intervention_name>
    <description>Patient were permitted to progressively weightbear on their heel at 2 week post-op.</description>
    <arm_group_label>(EWB) Early Weight Bearing (2 Weeks Post-op)</arm_group_label>
    <other_name>EWB</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient has signed the Institutional Review Board approved informed consent form&#xD;
             specific to this study prior to enrollment&#xD;
&#xD;
          -  Failure of conservative treatment (i.e. non-surgical action, consisting of footwear&#xD;
             modification in the form of shoes with wide toe boxes, padded inserts, activity&#xD;
             modifications and pain control medications)&#xD;
&#xD;
          -  Patients who underwent Lapidus procedure with or without other procedures of the first&#xD;
             ray (i.e., muscle-tendon procedures, distal metatarsal osteotomy, Akin procedure)&#xD;
&#xD;
          -  Patient older than 18 years of age&#xD;
&#xD;
          -  Patient is able to give informed consent&#xD;
&#xD;
          -  Patient is independent, ambulatory, and agrees to comply with all postoperative visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has a pre-existing condition which may cause impairment of healing and bone&#xD;
             fusion&#xD;
&#xD;
          -  Any significant pathology that, in the opinion of investigator, makes the patient&#xD;
             unsuitable for study&#xD;
&#xD;
          -  Patients who underwent Lapidus arthrodesis in conjunction with other procedures that&#xD;
             did not focus on the first pedal ray with the exception of harvesting autogenous&#xD;
             ipsilateral calcaneal bone graft&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orthopaedic Associates of Michigan, PC</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49525</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bednarz PA, Manoli A 2nd. Modified lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int. 2000 Oct;21(10):816-21. doi: 10.1177/107110070002101004.</citation>
    <PMID>11128011</PMID>
  </reference>
  <reference>
    <citation>Clark HR, Veith RG, Hansen ST Jr. Adolescent bunions treated by the modified Lapidus procedure. Bull Hosp Jt Dis Orthop Inst. 1987 Fall;47(2):109-22.</citation>
    <PMID>2825872</PMID>
  </reference>
  <reference>
    <citation>Saxena A, Nguyen A, Nelsen E. Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw. J Foot Ankle Surg. 2009 Mar-Apr;48(2):170-9. doi: 10.1053/j.jfas.2008.12.009.</citation>
    <PMID>19232969</PMID>
  </reference>
  <reference>
    <citation>Rutherford RL. The Lapidus procedure for primus metatarsus adductus. J Am Podiatry Assoc. 1974 Aug;64(8):581-4. doi: 10.7547/87507315-64-8-581. No abstract available.</citation>
    <PMID>4845803</PMID>
  </reference>
  <reference>
    <citation>McInnes BD, Bouche RT. Critical evaluation of the modified Lapidus procedure. J Foot Ankle Surg. 2001 Mar-Apr;40(2):71-90. doi: 10.1016/s1067-2516(01)80048-x.</citation>
    <PMID>11324674</PMID>
  </reference>
  <reference>
    <citation>Bacardi BE, Boysen TJ. Considerations for the Lapidus operation. J Foot Surg. 1986 Mar-Apr;25(2):133-8.</citation>
    <PMID>3711593</PMID>
  </reference>
  <reference>
    <citation>Christenson C, Jones RO, Basque M, Mollohan E. Comparison of oblique closing base wedge osteotomies of the first metatarsal: stripping versus nonstripping of the periosteum. J Foot Surg. 1991 Mar-Apr;30(2):107-13.</citation>
    <PMID>1865058</PMID>
  </reference>
  <reference>
    <citation>Hansen ST Jr. Hallux valgus surgery. Morton and Lapidus were right! Clin Podiatr Med Surg. 1996 Jul;13(3):347-54.</citation>
    <PMID>8829031</PMID>
  </reference>
  <reference>
    <citation>Mendicino R, Catanzariti AR, Hofbauer M, Saltrick KR. The modified lapidus arthrodesis: technical maneuvers and pearls. J Foot Ankle Surg. 2000 Jul-Aug;39(4):258-64. doi: 10.1016/s1067-2516(00)80010-1. No abstract available.</citation>
    <PMID>10949807</PMID>
  </reference>
  <results_reference>
    <citation>LAPIDUS PW. The author's bunion operation from 1931 to 1959. Clin Orthop. 1960;16:119-35. No abstract available.</citation>
    <PMID>14414101</PMID>
  </results_reference>
  <results_reference>
    <citation>Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.</citation>
    <PMID>2744666</PMID>
  </results_reference>
  <results_reference>
    <citation>Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301.</citation>
    <PMID>1601337</PMID>
  </results_reference>
  <results_reference>
    <citation>Hernandez A, Hernandez PA, Hernandez WA. Lapidus: when and why? Clin Podiatr Med Surg. 1989 Jan;6(1):197-208.</citation>
    <PMID>2653609</PMID>
  </results_reference>
  <results_reference>
    <citation>Catanzariti AR, Mendicino RW, Lee MS, Gallina MR. The modified Lapidus arthrodesis: a retrospective analysis. J Foot Ankle Surg. 1999 Sep-Oct;38(5):322-32. doi: 10.1016/s1067-2516(99)80003-9.</citation>
    <PMID>10553545</PMID>
  </results_reference>
  <results_reference>
    <citation>Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.</citation>
    <PMID>11232392</PMID>
  </results_reference>
  <results_reference>
    <citation>Ray RG. First metatarsocuneiform arthrodesis: technical considerations and technique modification. J Foot Ankle Surg. 2002 Jul-Aug;41(4):260-72. doi: 10.1016/s1067-2516(02)80025-4.</citation>
    <PMID>12194518</PMID>
  </results_reference>
  <results_reference>
    <citation>Kopp FJ, Patel MM, Levine DS, Deland JT. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int. 2005 Nov;26(11):913-7. doi: 10.1177/107110070502601103.</citation>
    <PMID>16309603</PMID>
  </results_reference>
  <results_reference>
    <citation>Coetzee JC, Resig SG, Kuskowski M, Saleh KJ. The Lapidus procedure as salvage after failed surgical treatment of hallux valgus. Surgical technique. J Bone Joint Surg Am. 2004 Mar;86-A Suppl 1:30-6. doi: 10.2106/00004623-200403001-00005.</citation>
    <PMID>14996919</PMID>
  </results_reference>
  <results_reference>
    <citation>Saffo G, Wooster MF, Stevens M, Desnoyers R, Catanzariti AR. First metatarsocuneiform joint arthrodesis: a five-year retrospective analysis. J Foot Surg. 1989 Sep-Oct;28(5):459-65.</citation>
    <PMID>2584630</PMID>
  </results_reference>
  <results_reference>
    <citation>Gutteck N, Wohlrab D, Zeh A, Radetzki F, Delank KS, Lebek S. Immediate fullweightbearing after tarsometatarsal arthrodesis for hallux valgus correction--Does it increase the complication rate? Foot Ankle Surg. 2015 Sep;21(3):198-201. doi: 10.1016/j.fas.2014.11.010. Epub 2014 Dec 29.</citation>
    <PMID>26235860</PMID>
  </results_reference>
  <results_reference>
    <citation>Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075.</citation>
    <PMID>21189208</PMID>
  </results_reference>
  <results_reference>
    <citation>Prissel MA, Hyer CF, Grambart ST, Bussewitz BW, Brigido SA, DiDomenico LA, Lee MS, Reeves CL, Shane AM, Tucker DJ, Weinraub GM. A Multicenter, Retrospective Study of Early Weightbearing for Modified Lapidus Arthrodesis. J Foot Ankle Surg. 2016 Mar-Apr;55(2):226-9. doi: 10.1053/j.jfas.2015.09.003. Epub 2016 Jan 5.</citation>
    <PMID>26763868</PMID>
  </results_reference>
  <results_reference>
    <citation>King CM, Richey J, Patel S, Collman DR. Modified lapidus arthrodesis with crossed screw fixation: early weightbearing in 136 patients. J Foot Ankle Surg. 2015 Jan-Feb;54(1):69-75. doi: 10.1053/j.jfas.2014.09.034. Epub 2014 Oct 31.</citation>
    <PMID>25451208</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>January 29, 2019</last_update_submitted>
  <last_update_submitted_qc>January 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Orthopaedic Associates of Michigan, PC</investigator_affiliation>
    <investigator_full_name>John G. Anderson, MD</investigator_full_name>
    <investigator_title>Orthopaedic Surgeon - Foot and Ankle</investigator_title>
  </responsible_party>
  <keyword>Lapidus Arthrodesis</keyword>
  <keyword>Early Weight Bearing</keyword>
  <keyword>First Tarsometatarsal Arthrodesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallux Valgus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03812237
org study id: OAM-TMT-01
nct id: NCT03812237
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A Prospective, Randomized, Controlled Trial Comparing Early Weight Bearing versus Non Weight
      Bearing Following Modified Lapidus Arthrodesis
The purpose of this prospective randomized control trial is to assess outcomes in patients
      who undergo modified Lapidus arthrodesis and whose postoperative management includes early
      weight bearing on heel (in a boot) and compare it to standard of care non weight bearing post
      operative management.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, Randomized, Controlled Trial
primary purpose: Treatment
masking: None (Open Label)
masking description: Patients were blinded to treatment until their 2 week post-operative visit.
measure: TMT Fusion Rate
time frame: 6 months
description: To compare the incidence and rate of first TMT fusion using two different postoperative protocols until fusion consolidation.
measure: American Foot & Ankle Society Midfoot Scores (AOFAS)
time frame: 12 months
description: Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period.] AOFAS Scale: [0 (no function/severe deformity) to 83 (full function/no limitations/deformity)]
measure: Short Musculoskeletal Function Assessment (SMFA)
time frame: 12 months
description: Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SMFA Scale: 101 items scored 1 to 5 [1( problems/no difficulty/not bothered) - 5 (unable to do task/symptoms constantly/extremely bothered)]
measure: Visual Analogue Scale (VAS)
time frame: 12 months
description: Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. VAS assessment: [0 (no pain) - 10 (worse possible pain)]
measure: Foot Function Index Revised (FFIr)
time frame: 12 months
description: Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. FFIr Scale: 67 items scored 1 to 7 [1(no problems/no difficulty/not bothered) - 6 (unable to do a task/symptoms all the time/worst pain imaginable) - 7 (Not applicable)]. Score range: 46 to 230.
measure: Short Form Health Survey (SF-36) v.2
time frame: 12 months
description: Assessment of clinical/subjective feedback via questionnaires during the postoperative follow up period. SF-36 v.2 Scale: Self-reporting outcomes assessment [0 (no function/severe physical/mental disability) to 100 (full function, no limitations to mental/physical health)]. Score range: 46 to 230.
arm group label: (EWB) Early Weight Bearing (2 Weeks Post-op)
arm group type: Experimental
description: Subjects in the EWB group were allowed to begin bearing 50 pounds (lbs) through their hindfoot in either the boot or the short leg cast at the two-week visit. They were allowed to advance their weightbearing as tolerated by 25 lbs every four days until full weightbearing through the hindfoot was achieved.
arm group label: (SOC) Standard of Care Weight Bearing (6-8 Weeks Post-op)
arm group type: No Intervention
description: Subjects in the SOC group were allowed to heel touch weightbear for balance only on the operative foot until the six to eight week visit. At this visit all subjects were placed into a short leg walking boot. Non-weightbearing patients were permitted to begin the progressive weightbearing protocol, without hindfoot restriction.
intervention type: Other
intervention name: (EWB) Early Weight Bearing (2 Weeks Post-op)
description: Patient were permitted to progressively weightbear on their heel at 2 week post-op.
arm group label: (EWB) Early Weight Bearing (2 Weeks Post-op)
other name: EWB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Bednarz PA, Manoli A 2nd. Modified lapidus procedure for the treatment of hypermobile hallux valgus. Foot Ankle Int. 2000 Oct;21(10):816-21. doi: 10.1177/107110070002101004.
PMID: 11128011
citation: Clark HR, Veith RG, Hansen ST Jr. Adolescent bunions treated by the modified Lapidus procedure. Bull Hosp Jt Dis Orthop Inst. 1987 Fall;47(2):109-22.
PMID: 2825872
citation: Saxena A, Nguyen A, Nelsen E. Lapidus bunionectomy: Early evaluation of crossed lag screws versus locking plate with plantar lag screw. J Foot Ankle Surg. 2009 Mar-Apr;48(2):170-9. doi: 10.1053/j.jfas.2008.12.009.
PMID: 19232969
citation: Rutherford RL. The Lapidus procedure for primus metatarsus adductus. J Am Podiatry Assoc. 1974 Aug;64(8):581-4. doi: 10.7547/87507315-64-8-581. No abstract available.
PMID: 4845803
citation: McInnes BD, Bouche RT. Critical evaluation of the modified Lapidus procedure. J Foot Ankle Surg. 2001 Mar-Apr;40(2):71-90. doi: 10.1016/s1067-2516(01)80048-x.
PMID: 11324674
citation: Bacardi BE, Boysen TJ. Considerations for the Lapidus operation. J Foot Surg. 1986 Mar-Apr;25(2):133-8.
PMID: 3711593
citation: Christenson C, Jones RO, Basque M, Mollohan E. Comparison of oblique closing base wedge osteotomies of the first metatarsal: stripping versus nonstripping of the periosteum. J Foot Surg. 1991 Mar-Apr;30(2):107-13.
PMID: 1865058
citation: Hansen ST Jr. Hallux valgus surgery. Morton and Lapidus were right! Clin Podiatr Med Surg. 1996 Jul;13(3):347-54.
PMID: 8829031
citation: Mendicino R, Catanzariti AR, Hofbauer M, Saltrick KR. The modified lapidus arthrodesis: technical maneuvers and pearls. J Foot Ankle Surg. 2000 Jul-Aug;39(4):258-64. doi: 10.1016/s1067-2516(00)80010-1. No abstract available.
PMID: 10949807
citation: LAPIDUS PW. The author's bunion operation from 1931 to 1959. Clin Orthop. 1960;16:119-35. No abstract available.
PMID: 14414101
citation: Sangeorzan BJ, Hansen ST Jr. Modified Lapidus procedure for hallux valgus. Foot Ankle. 1989 Jun;9(6):262-6. doi: 10.1177/107110078900900602.
PMID: 2744666
citation: Myerson M, Allon S, McGarvey W. Metatarsocuneiform arthrodesis for management of hallux valgus and metatarsus primus varus. Foot Ankle. 1992 Mar-Apr;13(3):107-15. doi: 10.1177/107110079201300301.
PMID: 1601337
citation: Hernandez A, Hernandez PA, Hernandez WA. Lapidus: when and why? Clin Podiatr Med Surg. 1989 Jan;6(1):197-208.
PMID: 2653609
citation: Catanzariti AR, Mendicino RW, Lee MS, Gallina MR. The modified Lapidus arthrodesis: a retrospective analysis. J Foot Ankle Surg. 1999 Sep-Oct;38(5):322-32. doi: 10.1016/s1067-2516(99)80003-9.
PMID: 10553545
citation: Myerson MS, Badekas A. Hypermobility of the first ray. Foot Ankle Clin. 2000 Sep;5(3):469-84.
PMID: 11232392
citation: Ray RG. First metatarsocuneiform arthrodesis: technical considerations and technique modification. J Foot Ankle Surg. 2002 Jul-Aug;41(4):260-72. doi: 10.1016/s1067-2516(02)80025-4.
PMID: 12194518
citation: Kopp FJ, Patel MM, Levine DS, Deland JT. The modified Lapidus procedure for hallux valgus: a clinical and radiographic analysis. Foot Ankle Int. 2005 Nov;26(11):913-7. doi: 10.1177/107110070502601103.
PMID: 16309603
citation: Coetzee JC, Resig SG, Kuskowski M, Saleh KJ. The Lapidus procedure as salvage after failed surgical treatment of hallux valgus. Surgical technique. J Bone Joint Surg Am. 2004 Mar;86-A Suppl 1:30-6. doi: 10.2106/00004623-200403001-00005.
PMID: 14996919
citation: Saffo G, Wooster MF, Stevens M, Desnoyers R, Catanzariti AR. First metatarsocuneiform joint arthrodesis: a five-year retrospective analysis. J Foot Surg. 1989 Sep-Oct;28(5):459-65.
PMID: 2584630
citation: Gutteck N, Wohlrab D, Zeh A, Radetzki F, Delank KS, Lebek S. Immediate fullweightbearing after tarsometatarsal arthrodesis for hallux valgus correction--Does it increase the complication rate? Foot Ankle Surg. 2015 Sep;21(3):198-201. doi: 10.1016/j.fas.2014.11.010. Epub 2014 Dec 29.
PMID: 26235860
citation: Goldstein CL, Schemitsch E, Bhandari M, Mathew G, Petrisor BA. Comparison of different outcome instruments following foot and ankle trauma. Foot Ankle Int. 2010 Dec;31(12):1075-80. doi: 10.3113/FAI.2010.1075.
PMID: 21189208
citation: Prissel MA, Hyer CF, Grambart ST, Bussewitz BW, Brigido SA, DiDomenico LA, Lee MS, Reeves CL, Shane AM, Tucker DJ, Weinraub GM. A Multicenter, Retrospective Study of Early Weightbearing for Modified Lapidus Arthrodesis. J Foot Ankle Surg. 2016 Mar-Apr;55(2):226-9. doi: 10.1053/j.jfas.2015.09.003. Epub 2016 Jan 5.
PMID: 26763868
citation: King CM, Richey J, Patel S, Collman DR. Modified lapidus arthrodesis with crossed screw fixation: early weightbearing in 136 patients. J Foot Ankle Surg. 2015 Jan-Feb;54(1):69-75. doi: 10.1053/j.jfas.2014.09.034. Epub 2014 Oct 31.
PMID: 25451208
responsible party type: Principal Investigator
investigator affiliation: Orthopaedic Associates of Michigan, PC
investigator full name: John G. Anderson, MD
investigator title: Orthopaedic Surgeon - Foot and Ankle
mesh term: Hallux Valgus
sharing ipd: No