Transarticular Lateral Release Versus Percutaneous Lateral Release in Combination With Distal Metatarsal Chevron Osteotomy for Hallux Valgus -A Prospective Randomized Controlled Trial-
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 主要终点
- intermetatarsal angle (IMA) 1-2 (degrees)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Distal soft tissue procedure with TALR (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.
干预措施: Distal soft tissue procedure with PCLR (Procedure)
结局指标
主要结局
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
时间窗: postoperative 36-months
functional score, 0-100, the higher the better
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 36-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
sesamoid position
时间窗: 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
时间窗: postoperative 36-months
pain score, (0-10, the lower the better)
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 1-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 2-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 3-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 6-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 12-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
hallux valgus angle (HVA)(degrees)
时间窗: postoperative 24-month
weightbearing dorsoplantar radiograph, angle between proximal phalanx and 1st metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 1-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 2-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 3-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 6-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 12-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
intermetatarsal angle (IMA) 1-2 (degrees)
时间窗: postoperative 24-month
weightbearing dorsoplantar radiograph, angle between 1st metatarsal and 2nd metatarsal
sesamoid position
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
visual analogue scale (VAS) for pain
时间窗: postoperative 3-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
时间窗: postoperative 6-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
时间窗: postoperative 12-months
pain score, (0-10, the lower the better)
visual analogue scale (VAS) for pain
时间窗: postoperative 24-months
pain score, (0-10, the lower the better)
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
时间窗: postoperative 3-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
时间窗: postoperative 6-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
时间窗: postoperative 12-months
functional score, 0-100, the higher the better
hallux-metatarsophalangeal-interphalangeal scale of American Orthopaedic Foot Ankle Society (AOFAS)
时间窗: postoperative 24-months
functional score, 0-100, the higher the better
次要结局
- rate of osteonecrosis of first metatarsal head(36-month)
- rate of recurrent hallux valgus(36-month)
- rate of hallux varus(36-month)
- rate of infection(36-month)
- rate of reoperations(36-month)
- rate of numbness of hallux(36-month)
- rate of first MTPJ arthritis(36-month)
- rate of infection(12-month)
- rate of infection(24-month)
- rate of osteonecrosis of first metatarsal head(12-month)
- rate of osteonecrosis of first metatarsal head(24-month)
- rate of numbness of hallux(12-month)
- rate of numbness of hallux(24-month)
- rate of first MTPJ arthritis(12-month)
- rate of first MTPJ arthritis(24-month)
- rate of recurrent hallux valgus(12-month)
- rate of recurrent hallux valgus(24-month)
- rate of hallux varus(12-month)
- rate of hallux varus(24-month)
- rate of reoperations(12-month)
- rate of reoperations(24-month)