Achilles Tendon Rupture
Conditions
Keywords
immobilization duration, open surgery, early rehabilitation
Brief summary
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
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.
Interventions
PROCEDUREimmobilization duration
brace immobilization duration after open surgery for Achilles tendon rupture
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the time of return to light sports activity | from operation to 1-year follow-up after the surgery | when the patients are able to do jogging or rapid walk after the surgery, the time will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| range of motion (ROM) recovery time | from operation to 1-year follow-up after the surgery | the recovery time will be recorded when the ROM is similar to that of the uninjured side. |
| recovery time of the single-legged heel rise height (SHRH) | from operation to 1-year follow-up after the surgery | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| visual analogue scale (VAS) | 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery | VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain. |
| American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score | 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery | The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points. |
| the Achilles tendon Total Rupture Score (ATRS) | 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery | 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. |
Countries
China
Contacts
Primary ContactYang Lv, M.D.
Backup ContactXiangyu Xu, M.D.
Outcome results
None listed