Clinical trial NCT04956614: Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Official title: Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Tendon Rupture
Keywords: Duration of immobilisation
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-09
Enrollment: 266
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 novel Achilles tendon rupture repaired , patients were randomly divided into 4 groups according to immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the same suture technique with a similar rehabilitation protocol and were examined clinically at 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the groups.

Detailed description: This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilisation duration by dividing the patients into four groups according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture technique. The primary outcome was the time of return to light sports activity (LSA). Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH). Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS) were also collected. Demographic baseline data were analysed using one-way analysis of variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05.

The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

The excluded criteria were patients with prior ATR and those without rehabilitation or follow-up outcomes. Other situations that affected patients' lower limb functions or tendon healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were also excluded.

Eligibility criteria: Inclusion Criteria:

patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

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:
References: