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| ID | Type | Description | Link |
|---|---|---|---|
| 81702127 | Other Grant/Funding Number | National Natural Science Foundation of China | |
| 2018YFF0301100 | Other Grant/Funding Number | Science and Technology fund of Winter Olympics |
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This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired by our suture technique, patients were randomly divided into 4 groups, and the brace fixation time was 0, 2, 4 and 6 weeks, respectively, to study the difference in efficacy between the groups.
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilization times by dividing the patients into four groups-A, B, C, and D-based on the amount of immobilization time (0, 2, 4, and 6 weeks, respectively) that include a similar rehabilitation protocol. The inclusion criteria are patients with an acute closed single-legged complete Achilles tendon rupture, and an age of 18 to 60 years. The exclusion criteria are patients with prior Achilles tendon rupture or other situations that affect their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). Other exclusion criteria are an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion is less than 3.5 cm), or those without rehabilitation or follow-up outcomes. All patients will be treated surgically with the same suture technique and undergo a similar rehabilitation protocol after the brace is removed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0-week immobilization | Experimental | 0-week brace immobilization after the surgery will be conducted. |
|
| 2-week immobilization | Experimental | 2-week brace immobilization after the surgery will be conducted. |
|
| 4-week immobilization | Other | 4-week brace immobilization after the surgery will be conducted. |
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| 6-week immobilization | Other | 6-week brace immobilization after the surgery will be conducted. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immobilization duration | Procedure | brace immobilization duration after open surgery for Achilles tendon rupture |
|
| Measure | Description | Time Frame |
|---|---|---|
| the time of return to light sports activity | when the patients are able to do jogging or rapid walk after the surgery, the time will be recorded. | from operation to 1-year follow-up after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| range of motion (ROM) recovery time | the recovery time will be recorded when the ROM is similar to that of the uninjured side. | from operation to 1-year follow-up after the surgery |
| recovery time of the single-legged heel rise height (SHRH) |
| Measure | Description | Time Frame |
|---|---|---|
| visual analogue scale (VAS) | VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain. | 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery |
| American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yang Lv, M.D. | Contact | +86-18513112060 | lvyang42@126.com | |
| Xiangyu Xu, M.D. | Contact | +86-15210849431 | 307542744@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Jie Qiao, M.D. | Peking University Third Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42036692 | Derived | Wei Z, Cui Z, Cao Y, Li X, Fu Y, Bai L, Lv Y. Comparative analysis of different mobility aids in the early accelerated rehabilitation phase following acute achilles tendon repair surgery: a prospective cohort study. J Orthop Surg Res. 2026 Apr 27;21(1):279. doi: 10.1186/s13018-026-06881-6. | |
| 40652259 | Derived |
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The heel rise height is measured as the distance from the ground to the heel when the patient lift the heel while keeping the knee straight. The recovery time is noted when the SHRH is similar to that of the opposite leg.
| from operation to 1-year follow-up after the surgery |
The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
| 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery |
| the Achilles tendon Total Rupture Score (ATRS) | The ATRS includes 10 items; each item has a score ranging between 0 and 10 on a Likert scale, with 100 indicating no major limitations. | 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery |
| Cao Y, Li X, Cui Z, Lv Y, Si G. Open surgery and minimally invasive repair of acute Achilles tendon rupture: stratified outcomes based on immobilization duration in a prospective cohort study. J Orthop Surg Res. 2025 Jul 12;20(1):647. doi: 10.1186/s13018-025-06019-0. |
| 39169350 | Derived | Cao Y, Gao S, Cui Z, Fu Y, Bai L, Si G, Fan J, Lv Y, Zhou F. Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study. J Orthop Surg Res. 2024 Aug 21;19(1):497. doi: 10.1186/s13018-024-04970-y. |