Clinical trial NCT04663542: The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery
Official title: A Prospective Randomized Controlled Clinical Trial on the Comparison of the Treatment Outcomes of Different Immobilization Times After the Repair of Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: immobilization duration
open surgery
early rehabilitation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: the time of return to light sports activity
timeFrame: from operation to 1-year follow-up after the surgery
Secondary outcomes:
measure: range of motion (ROM) recovery time
timeFrame: from operation to 1-year follow-up after the surgery
measure: recovery time of the single-legged heel rise height (SHRH)
timeFrame: from operation to 1-year follow-up after the surgery
Other outcomes:
measure: visual analogue scale (VAS)
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
measure: American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
measure: the Achilles tendon Total Rupture Score (ATRS)
timeFrame: 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao, M.D.
role: STUDY_CHAIR
References: