Clinical trial NCT04614675: Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus
Official title: Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hallux Valgus
Keywords: Hallux valgus
Distal soft tissue procedure
Transarticular lateral release (TALR)
Percutaneous lateral release (PCLR)
Minimally invasive surgery
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-11-04
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 1-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 2-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 3-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 6-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 12-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 24-month
measure: hallux valgus angle (HVA)(degrees)
timeFrame: postoperative 36-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 1-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 2-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 3-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 6-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 12-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 24-month
measure: intermetatarsal angle (IMA) 1-2 (degrees)
timeFrame: postoperative 36-month
measure: sesamoid position
timeFrame: postoperative 1-month
measure: sesamoid position
timeFrame: postoperative 2-month
measure: sesamoid position
timeFrame: postoperative 3-month
measure: sesamoid position
timeFrame: postoperative 6-month
measure: sesamoid position
timeFrame: postoperative 12-month
measure: sesamoid position
timeFrame: postoperative 24-month
measure: sesamoid position
timeFrame: postoperative 36-month
measure: visual analogue scale (VAS) for pain
timeFrame: postoperative 3-months
measure: visual analogue scale (VAS) for pain
timeFrame: postoperative 6-months
measure: visual analogue scale (VAS) for pain
timeFrame: postoperative 12-months
measure: visual analogue scale (VAS) for pain
timeFrame: postoperative 24-months
measure: visual analogue scale (VAS) for pain
timeFrame: postoperative 36-months
measure: hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
timeFrame: postoperative 3-months
measure: hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
timeFrame: postoperative 6-months
measure: hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
timeFrame: postoperative 12-months
measure: hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
timeFrame: postoperative 24-months
measure: hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
timeFrame: postoperative 36-months
Secondary outcomes:
measure: rate of osteonecrosis of first metatarsal head
timeFrame: 12-month
measure: rate of osteonecrosis of first metatarsal head
timeFrame: 24-month
measure: rate of osteonecrosis of first metatarsal head
timeFrame: 36-month
measure: rate of numbness of hallux
timeFrame: 12-month
measure: rate of numbness of hallux
timeFrame: 24-month
measure: rate of numbness of hallux
timeFrame: 36-month
measure: rate of infection
timeFrame: 12-month
measure: rate of infection
timeFrame: 24-month
measure: rate of infection
timeFrame: 36-month
measure: rate of first MTPJ arthritis
timeFrame: 12-month
measure: rate of first MTPJ arthritis
timeFrame: 24-month
measure: rate of first MTPJ arthritis
timeFrame: 36-month
measure: rate of recurrent hallux valgus
timeFrame: 12-month
measure: rate of recurrent hallux valgus
timeFrame: 24-month
measure: rate of recurrent hallux valgus
timeFrame: 36-month
measure: rate of hallux varus
timeFrame: 12-month
measure: rate of hallux varus
timeFrame: 24-month
measure: rate of hallux varus
timeFrame: 36-month
measure: rate of reoperations
timeFrame: 12-month
measure: rate of reoperations
timeFrame: 24-month
measure: rate of reoperations
timeFrame: 36-month
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Veterans General Hospital, Taiwan
name: Chao-Ching Chiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.