Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

NCT ID: NCT04956614

Last Updated: 2021-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 266 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-07-01

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.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

suture of Achilles tendon without immobilisation

Group Type: EXPERIMENTAL

immobilisation duration

Intervention Type: DEVICE

immobilisation duration of 2,4,6 week after suture of Achilles tendon

suture of Achilles tendon with immobilisation

Group Type: EXPERIMENTAL

immobilisation duration

Intervention Type: DEVICE

immobilisation duration of 2,4,6 week after suture of Achilles tendon

Interventions

immobilisation duration

immobilisation duration of 2,4,6 week after suture of Achilles tendon

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

LM2020252

Identifier Type: -

Identifier Source: org_study_id