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Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus

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ClinicalTrials.gov Identifier: NCT04614675
Recruitment Status : Not yet recruiting
First Posted : November 4, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:

background Hallux valgus (HV) is a common forefoot disorder in need of surgical intervention after failed conservative treatment. Surgical treatment of HV generally includes different kinds of osteotomy in combination with different distal soft tissue procedures (DSTP). Commonly used DSTP are open first-web lateral release, transarticular lateral release (TALR), and percutaneous lateral release (PCLR). In some studies, TALR showed similar surgical outcomes with open first-web space lateral release. Besides, PCLR has been described with satisfactory outcomes. TALR and PCLR are gaining popularity due to their less invasive approach and potential in combination with a distal metatarsal Chevron osteotomy (DMCO). Currently, there is no study comparing the surgical results between TALR and PCLR for surgical reconstruction of HV.

Aim The aim of this prospective randomized trial is to compare the surgical outcomes of TALR versus PCLR, both in combination of DMCO, for the treatment of HV. Our hypothesis is that TALR would achieve a better surgical outcomes than PCLR.


Condition or disease Intervention/treatment Phase
Hallux Valgus Procedure: Distal soft tissue procedure with TALR Procedure: Distal soft tissue procedure with PCLR Not Applicable

Detailed Description:

This study will be conducted from January, 2021 to December, 2024. A total of 140 participants are included with 70 participants in each group. Participants are allocated to TALR or PCLR group before index surgery according to a computer-generated randomization list.

For all patients, after regional nerve block and adequate sedation, intraoperative stress test is performed for flexibility of first metatarsophalangeal joint (MTPJ).6 The test is confirmed with dorsoplantar fluoroscopy. Only the cases with negative results (passive correction is not possible) are included. Then, a medial incision of 2.5-cm is made at distal metatarsal head and a reverse L-shaped medial capsulotomy is made followed by TALR or PCLR.

After TALR or PCLR, medial bunionectomy is performed. DMCO is made with the apex at distal metatarsal neck and angle of 60 to 90 degrees. The metatarsal head is laterally moved and fixed with one or 2 oblique headless compression screws.

Postoperative followup The patients are followed up at two weeks for removal of stitches, then 1-month, 2-month, 3-month, 6-months, 1-year, and annually after 1 year for radiographic , functional assessments, and evaluation of complications.

Power analysis for patient number With the assumption of mean HVA are 10 degrees for TALR group and 15 degrees for PCLR group at final followup, and a standard deviation of 8 degrees for both groups, the calculated effect size d is 0.625. In order to achieve the α error probability of 0.05 and power of 0.95, 68 participants in each group are necessary with a total of 136 participants in this study.

Statistical analysis In the comparisons between TALR and PCLR groups, the independent two samples t-test and the Mann-Whitney test are performed for normal and non-normal distributed data respectively, and the Fisher's exact test is performed for categorical data. P-values less than 0.05 is considered to be statistical significant. The statistical analyses are performed by using SPSS 25.0 statistics software (SPSS Inc, Chicago, USA).

Clinical relevance

  1. Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon.
  2. If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Bunion

Arm Intervention/treatment
Active Comparator: Transarticular lateral release (TALR)
TALR The first toe is pulled distally for access into the lateral aspect of first MTPJ. A No.15 beaver blade is advanced from the medial incision laterally to divide the lateral capsule vertically and adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction.
Procedure: Distal soft tissue procedure with TALR
TALR group: Transarticular lateral release as the distal soft tissue procedure

Active Comparator: Percutaneous lateral release (PCLR)
PCLR A 0.5 cm stab wound is made at lateral aspect of first MTPJ. A No. 15 beaver blade is advanced into the lateral side of MTPJ with a quarter of the blade inside the joint and verified with fluoroscope. The blade is turned laterally to face the adductor hallucis tendon. The adductor tendon is divided with lateral movement of the blade and varus manipulation of proximal phalanx. A click is heard as adequate release of adductor hallucis tendon. Same intraoperative stress test is performed and recorded under fluoroscope to confirm correction.
Procedure: Distal soft tissue procedure with PCLR
PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure




Primary Outcome Measures :
  1. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 1-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  2. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 2-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  3. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 3-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  4. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 6-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  5. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 12-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  6. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 24-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  7. hallux valgus angle (HVA)(degrees) [ Time Frame: postoperative 36-month ]
    weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal

  8. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 1-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  9. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 2-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  10. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 3-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  11. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 6-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  12. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 12-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  13. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 24-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  14. intermetatarsal angle (IMA) 1-2 (degrees) [ Time Frame: postoperative 36-month ]
    weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal

  15. sesamoid position [ Time Frame: postoperative 1-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  16. sesamoid position [ Time Frame: postoperative 2-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  17. sesamoid position [ Time Frame: postoperative 3-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  18. sesamoid position [ Time Frame: postoperative 6-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  19. sesamoid position [ Time Frame: postoperative 12-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  20. sesamoid position [ Time Frame: postoperative 24-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  21. sesamoid position [ Time Frame: postoperative 36-month ]
    weightbearing dorsoplantar radiograph, the location of the medial sesamoid with progressive lateral subluxation from grade one to seven according to the classification system of Hardy and Clapham

  22. visual analogue scale (VAS) for pain [ Time Frame: postoperative 3-months ]
    pain score, (0-10, the lower the better)

  23. visual analogue scale (VAS) for pain [ Time Frame: postoperative 6-months ]
    pain score, (0-10, the lower the better)

  24. visual analogue scale (VAS) for pain [ Time Frame: postoperative 12-months ]
    pain score, (0-10, the lower the better)

  25. visual analogue scale (VAS) for pain [ Time Frame: postoperative 24-months ]
    pain score, (0-10, the lower the better)

  26. visual analogue scale (VAS) for pain [ Time Frame: postoperative 36-months ]
    pain score, (0-10, the lower the better)

  27. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) [ Time Frame: postoperative 3-months ]
    functional score, 0-100, the higher the better

  28. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) [ Time Frame: postoperative 6-months ]
    functional score, 0-100, the higher the better

  29. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) [ Time Frame: postoperative 12-months ]
    functional score, 0-100, the higher the better

  30. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) [ Time Frame: postoperative 24-months ]
    functional score, 0-100, the higher the better

  31. hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS) [ Time Frame: postoperative 36-months ]
    functional score, 0-100, the higher the better


Secondary Outcome Measures :
  1. rate of osteonecrosis of first metatarsal head [ Time Frame: 12-month ]
    postoperative complications

  2. rate of osteonecrosis of first metatarsal head [ Time Frame: 24-month ]
    postoperative complications

  3. rate of osteonecrosis of first metatarsal head [ Time Frame: 36-month ]
    postoperative complications

  4. rate of numbness of hallux [ Time Frame: 12-month ]
    postoperative complication

  5. rate of numbness of hallux [ Time Frame: 24-month ]
    postoperative complication

  6. rate of numbness of hallux [ Time Frame: 36-month ]
    postoperative complication

  7. rate of infection [ Time Frame: 12-month ]
    postoperative complication

  8. rate of infection [ Time Frame: 24-month ]
    postoperative complication

  9. rate of infection [ Time Frame: 36-month ]
    postoperative complication

  10. rate of first MTPJ arthritis [ Time Frame: 12-month ]
    postoperative complication

  11. rate of first MTPJ arthritis [ Time Frame: 24-month ]
    postoperative complication

  12. rate of first MTPJ arthritis [ Time Frame: 36-month ]
    postoperative complication

  13. rate of recurrent hallux valgus [ Time Frame: 12-month ]
    postoperative complication, hallux valgus angle equal or greater than 20 degrees

  14. rate of recurrent hallux valgus [ Time Frame: 24-month ]
    postoperative complication, hallux valgus angle equal or greater than 20 degrees

  15. rate of recurrent hallux valgus [ Time Frame: 36-month ]
    postoperative complication, hallux valgus angle equal or greater than 20 degrees

  16. rate of hallux varus [ Time Frame: 12-month ]
    postoperative complication

  17. rate of hallux varus [ Time Frame: 24-month ]
    postoperative complication

  18. rate of hallux varus [ Time Frame: 36-month ]
    postoperative complication

  19. rate of reoperations [ Time Frame: 12-month ]
    postoperative complication

  20. rate of reoperations [ Time Frame: 24-month ]
    postoperative complication

  21. rate of reoperations [ Time Frame: 36-month ]
    postoperative complication



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age equal or greater than 20 years
  • Hallux valgus angle (HVA) equal or greater than 20 degrees
  • Persistent symptoms after failed conservative treatment
  • Receiving DMCO for HV

Exclusion Criteria:

  • Underlying rheumatoid or other inflammatory arthritis
  • Hallux rigidus
  • Recurrent hallux valgus after previous surgery
  • First tarsometatarsal hypermobility
  • A positive intraoperative stress test for lateral soft tissue release

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04614675


Contacts
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Contact: Chao-Ching Chiang, MD +886-2-28757557 ext 140 1966chiang@gmail.com

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Chao-Ching Chiang, MD Taipei Veterans General Hospital, Taiwan
Publications:

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04614675    
Other Study ID Numbers: 2020-07-021B
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
Hallux valgus
Distal soft tissue procedure
Transarticular lateral release (TALR)
Percutaneous lateral release (PCLR)
Minimally invasive surgery
Additional relevant MeSH terms:
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Hallux Valgus
Bunion
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired