Hallux ValgusNCT04614675
Transarticular Lateral Release Versus Percutaneous Lateral Release for Hallux Valgus
A study testing Distal soft tissue procedure with TALR and Distal soft tissue procedure with PCLR in people with Hallux Valgus, run by Taipei Veterans General Hospital, Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Distal soft tissue procedure with TALR and Distal soft tissue procedure with PCLR
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
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.
Read the 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
- Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon.
- If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.
- Conditions
- Hallux Valgus
- Being tested
- Distal soft tissue procedure with TALR, Distal soft tissue procedure with PCLR
- Keywords
- Hallux valgus, Distal soft tissue procedure, Transarticular lateral release (TALR), Percutaneous lateral release (PCLR), Minimally invasive surgery
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal soft tissue procedure with TALRProcedure or surgery
TALR group: Transarticular lateral release as the distal soft tissue procedure
Distal soft tissue procedure with PCLRProcedure or surgery
PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure
| Study group | Role | What they receive |
|---|---|---|
| Transarticular lateral release (TALR) | Active comparator | 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. Receives: Procedure: Distal soft tissue procedure with TALR |
| Percutaneous lateral release (PCLR) | Active comparator | 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. Receives: Procedure: Distal soft tissue procedure with PCLR |
What is being measured
The primary outcome is the main question the study is designed to answer.
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 1-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 2-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 3-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 6-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 12-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 24-month
hallux valgus angle (HVA)(degrees)
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
Measured: postoperative 36-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 1-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 2-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 3-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 6-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 12-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 24-month
intermetatarsal angle (IMA) 1-2 (degrees)
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
Measured: postoperative 36-month
sesamoid position
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
Measured: postoperative 1-month
sesamoid position
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
Measured: postoperative 2-month
sesamoid position
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
Measured: postoperative 3-month
sesamoid position
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
Measured: postoperative 6-month
sesamoid position
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
Measured: postoperative 12-month
sesamoid position
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
Measured: postoperative 24-month
sesamoid position
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
Measured: postoperative 36-month
visual analogue scale (VAS) for pain
pain score, (0-10, the lower the better)
Measured: postoperative 3-months
visual analogue scale (VAS) for pain
pain score, (0-10, the lower the better)
Measured: postoperative 6-months
visual analogue scale (VAS) for pain
pain score, (0-10, the lower the better)
Measured: postoperative 12-months
visual analogue scale (VAS) for pain
pain score, (0-10, the lower the better)
Measured: postoperative 24-months
visual analogue scale (VAS) for pain
pain score, (0-10, the lower the better)
Measured: postoperative 36-months
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
functional score, 0-100, the higher the better
Measured: postoperative 3-months
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
functional score, 0-100, the higher the better
Measured: postoperative 6-months
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
functional score, 0-100, the higher the better
Measured: postoperative 12-months
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
functional score, 0-100, the higher the better
Measured: postoperative 24-months
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
functional score, 0-100, the higher the better
Measured: postoperative 36-months
Secondary outcomes (21)
rate of osteonecrosis of first metatarsal head
postoperative complications
Measured: 12-month
rate of osteonecrosis of first metatarsal head
postoperative complications
Measured: 24-month
rate of osteonecrosis of first metatarsal head
postoperative complications
Measured: 36-month
rate of numbness of hallux
postoperative complication
Measured: 12-month
rate of numbness of hallux
postoperative complication
Measured: 24-month
rate of numbness of hallux
postoperative complication
Measured: 36-month
rate of infection
postoperative complication
Measured: 12-month
rate of infection
postoperative complication
Measured: 24-month
rate of infection
postoperative complication
Measured: 36-month
rate of first MTPJ arthritis
postoperative complication
Measured: 12-month
rate of first MTPJ arthritis
postoperative complication
Measured: 24-month
rate of first MTPJ arthritis
postoperative complication
Measured: 36-month
rate of recurrent hallux valgus
postoperative complication, hallux valgus angle equal or greater than 20 degrees
Measured: 12-month
rate of recurrent hallux valgus
postoperative complication, hallux valgus angle equal or greater than 20 degrees
Measured: 24-month
rate of recurrent hallux valgus
postoperative complication, hallux valgus angle equal or greater than 20 degrees
Measured: 36-month
rate of hallux varus
postoperative complication
Measured: 12-month
rate of hallux varus
postoperative complication
Measured: 24-month
rate of hallux varus
postoperative complication
Measured: 36-month
rate of reoperations
postoperative complication
Measured: 12-month
rate of reoperations
postoperative complication
Measured: 24-month
rate of reoperations
postoperative complication
Measured: 36-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Jan 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Chao-Ching Chiang, MD, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614675
- Sponsor's protocol ID
- 2020-07-021B
- Status last verified
- Oct 2020
- First submitted
- 19 Jul 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26152873Lee 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.
PubMed 25628283Park 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.
PubMed 23632675Park 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.
PubMed 24196470Ahn 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.
PubMed 23917851de 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.
PubMed 31055210Lucas 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.
PubMed 26920962Bock 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.
PubMed 26246258Kim 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.
PubMed 21733437Choi 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.
PubMed 23050706Dalmau-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.
PubMed 32456480Okuda 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.
PubMed 19571086
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
- ClinicalTrials.gov ID
- NCT04614675
- Acronym / sponsor ID
- 2020-07-021B
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, Distal soft tissue procedure, Transarticular lateral release (TALR), Percutaneous lateral release (PCLR), Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 1 Jan 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 4 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Compare the differences of surgical outcomes between TALR and PCLR. These results could offer valuable information for foot and ankle surgeon.
- If PCLR is not adequate to achieve satisfactory outcomes, the minimally invasive surgery using PCLR for HV is not recommended.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transarticular lateral release (TALR) | Active comparator | Procedure: Distal soft tissue procedure with TALRTALR 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. |
| Percutaneous lateral release (PCLR) | Active comparator | Procedure: Distal soft tissue procedure with PCLRPCLR 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distal soft tissue procedure with TALRTALR group: Transarticular lateral release as the distal soft tissue procedure | Procedure or surgery | Transarticular lateral release (TALR) |
| Distal soft tissue procedure with PCLRPCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure | Procedure or surgery | Percutaneous lateral release (PCLR) |
Primary outcome
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 1-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 2-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 3-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 6-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 12-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 24-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
Time frame: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 1-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 2-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 3-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 6-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 12-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 24-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
Time frame: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
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
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
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
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
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
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
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
visual analogue scale (VAS) for pain
Time frame: postoperative 3-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
Time frame: postoperative 6-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
Time frame: postoperative 12-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
Time frame: postoperative 24-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
Time frame: postoperative 36-months
pain score, (0-10, the lower the better)
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time frame: postoperative 3-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time frame: postoperative 6-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time frame: postoperative 12-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time frame: postoperative 24-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
Time frame: postoperative 36-months
functional score, 0-100, the higher the better
21 secondary outcomes
rate of osteonecrosis of first metatarsal head
Time frame: 12-month
rate of osteonecrosis of first metatarsal head
Time frame: 24-month
rate of osteonecrosis of first metatarsal head
Time frame: 36-month
rate of numbness of hallux
Time frame: 12-month
rate of numbness of hallux
Time frame: 24-month
rate of numbness of hallux
Time frame: 36-month
rate of infection
Time frame: 12-month
rate of infection
Time frame: 24-month
rate of infection
Time frame: 36-month
rate of first MTPJ arthritis
Time frame: 12-month
rate of first MTPJ arthritis
Time frame: 24-month
rate of first MTPJ arthritis
Time frame: 36-month
rate of recurrent hallux valgus
Time frame: 12-month
rate of recurrent hallux valgus
Time frame: 24-month
rate of recurrent hallux valgus
Time frame: 36-month
rate of hallux varus
Time frame: 12-month
rate of hallux varus
Time frame: 24-month
rate of hallux varus
Time frame: 36-month
rate of reoperations
Time frame: 12-month
rate of reoperations
Time frame: 24-month
rate of reoperations
Time frame: 36-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
- Background: PubMed 26152873Wagner 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.
- Background: PubMed 25628283Lee 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.
- Background: PubMed 23632675Park 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.
- Background: PubMed 24196470Park 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.
- Background: PubMed 23917851Ahn 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.
- Background: PubMed 31055210de 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.
- Background: PubMed 26920962Lucas 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.
- Background: PubMed 26246258Bock 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.
- Background: PubMed 21733437Kim 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.
- Background: PubMed 23050706Choi 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.
- Background: PubMed 32456480Dalmau-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.
- Background: PubMed 19571086Okuda 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao-Ching Chiang, MD principal investigator
Taipei Veterans General Hospital, Taiwan
Questions about this trial
What is this clinical trial studying?
A study testing Distal soft tissue procedure with TALR and Distal soft tissue procedure with PCLR in people with Hallux Valgus, run by Taipei Veterans General Hospital, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao-Ching Chiang, MD (+886-2-28757557 ext. 140, 1966chiang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hallux valgus angle (HVA)(degrees) (time frame: postoperative 1-month). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04614675, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2020.