The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Procedure: immobilization duration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute closed single-legged complete Achilles tendon rupture age of 18 to 60 years. Exclusion Criteria: patients with prior Achilles tendon rupture or other situations that affected their lower limb functions or tendon healing (e.g., autoimmune disease, diabetes mellitus, systemic corticosteroid treatment). an inability to complete our suture technique (e.g., the distance from the rupture site to the Achilles tendon insertion was less than 3.5 cm) those without rehabilitation or follow-up outcomes.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0-week immobilization<br>0-week brace immobilization after the surgery will be conducted. | Procedure: immobilization duration<br>* brace immobilization duration after open surgery for Achilles tendon rupture<br>|
| Experimental: 2-week immobilization<br>2-week brace immobilization after the surgery will be conducted. | Procedure: immobilization duration<br>* brace immobilization duration after open surgery for Achilles tendon rupture<br>|
| Other: 4-week immobilization<br>4-week brace immobilization after the surgery will be conducted. | Procedure: immobilization duration<br>* brace immobilization duration after open surgery for Achilles tendon rupture<br>|
| Other: 6-week immobilization<br>6-week brace immobilization after the surgery will be conducted. | Procedure: immobilization duration<br>* brace immobilization duration after open surgery for Achilles tendon rupture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immobilization duration, open surgery, early rehabilitation