Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus
NCT ID: NCT04614675
Last Updated: 2020-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2021-01-01
2024-12-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Distal soft tissue procedure with TALR
TALR group: Transarticular lateral release as the distal soft tissue procedure
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.
Distal soft tissue procedure with PCLR
PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure
Interventions
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Distal soft tissue procedure with TALR
TALR group: Transarticular lateral release as the distal soft tissue procedure
Distal soft tissue procedure with PCLR
PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure
Eligibility Criteria
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Inclusion Criteria
* Hallux valgus angle (HVA) equal or greater than 20 degrees
* Persistent symptoms after failed conservative treatment
* Receiving DMCO for HV
Exclusion Criteria
* Hallux rigidus
* Recurrent hallux valgus after previous surgery
* First tarsometatarsal hypermobility
* A positive intraoperative stress test for lateral soft tissue release
20 Years
ALL
No
Sponsors
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Taipei Veterans General Hospital, Taiwan
OTHER_GOV
Responsible Party
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Principal Investigators
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Chao-Ching Chiang, MD
Role: PRINCIPAL_INVESTIGATOR
Taipei Veterans General Hospital, Taiwan
Central Contacts
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References
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Wagner E, Ortiz C, Figueroa F, Vela O, Wagner P, Gould JS. Role of a Limited Transarticular Release in Severe Hallux Valgus Correction. Foot Ankle Int. 2015 Nov;36(11):1322-9. doi: 10.1177/1071100715593082. Epub 2015 Jul 7.
Lee KB, Cho NY, Park HW, Seon JK, Lee SH. A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial. Bone Joint J. 2015 Feb;97-B(2):202-7. doi: 10.1302/0301-620X.97B2.34449.
Park CH, Jang JH, Lee SH, Lee WC. A comparison of proximal and distal chevron osteotomy for the correction of moderate hallux valgus deformity. Bone Joint J. 2013 May;95-B(5):649-56. doi: 10.1302/0301-620X.95B5.30181.
Park YB, Lee KB, Kim SK, Seon JK, Lee JY. Comparison of distal soft-tissue procedures combined with a distal chevron osteotomy for moderate to severe hallux valgus: first web-space versus transarticular approach. J Bone Joint Surg Am. 2013 Nov 6;95(21):e158. doi: 10.2106/JBJS.L.01017.
Ahn JY, Lee HS, Chun H, Kim JS, Seo DK, Choi YR, Kim SW. Comparison of open lateral release and transarticular lateral release in distal chevron metatarsal osteotomy for hallux valgus correction. Int Orthop. 2013 Sep;37(9):1781-7. doi: 10.1007/s00264-013-2023-1. Epub 2013 Aug 6.
de Las Heras-Romero J, Lledo-Alvarez AM, Andres-Grau J, Picazo-Marin F, Moreno-Sanchez JF, Hernandez-Torralba M. A new minimally extended distal Chevron osteotomy (MEDCO) with percutaneous soft tissue release (PSTR) for treatment of moderate hallux valgus. Foot (Edinb). 2019 Sep;40:27-33. doi: 10.1016/j.foot.2019.04.001. Epub 2019 Apr 4.
Lucas y Hernandez J, Golano P, Roshan-Zamir S, Darcel V, Chauveaux D, Laffenetre O. Treatment of moderate hallux valgus by percutaneous, extra-articular reverse-L Chevron (PERC) osteotomy. Bone Joint J. 2016 Mar;98-B(3):365-73. doi: 10.1302/0301-620X.98B3.35666.
Bock P, Kluger R, Kristen KH, Mittlbock M, Schuh R, Trnka HJ. The Scarf Osteotomy with Minimally Invasive Lateral Release for Treatment of Hallux Valgus Deformity: Intermediate and Long-Term Results. J Bone Joint Surg Am. 2015 Aug 5;97(15):1238-45. doi: 10.2106/JBJS.N.00971.
Kim HN, Suh DH, Hwang PS, Yu SO, Park YW. Role of intraoperative varus stress test for lateral soft tissue release during chevron bunion procedure. Foot Ankle Int. 2011 Apr;32(4):362-7. doi: 10.3113/FAI.2011.0362.
Choi YR, Lee HS, Jeong JJ, Kim SW, Jeon IH, Lee DH, Lee WC. Hallux valgus correction using transarticular lateral release with distal chevron osteotomy. Foot Ankle Int. 2012 Oct;33(10):838-43. doi: 10.3113/FAI.2012.0838.
Dalmau-Pastor M, Malagelada F, Cordier G, Del Vecchio JJ, Ghioldi ME, Vega J. Anatomical Study of Minimally Invasive Lateral Release Techniques for Hallux Valgus Treatment. Foot Ankle Int. 2020 Aug;41(8):984-992. doi: 10.1177/1071100720920863. Epub 2020 May 26.
Okuda R, Kinoshita M, Yasuda T, Jotoku T, Kitano N, Shima H. Postoperative incomplete reduction of the sesamoids as a risk factor for recurrence of hallux valgus. J Bone Joint Surg Am. 2009 Jul;91(7):1637-45. doi: 10.2106/JBJS.H.00796.
Other Identifiers
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2020-07-021B
Identifier Type: -
Identifier Source: org_study_id