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

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.

Study Overview

• Status: Completed
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Device: immobilisation duration

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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: suture of Achilles tendon without immobilisation	Device: immobilisation duration; immobilisation duration of 2,4,6 week after suture of Achilles tendon
Experimental: suture of Achilles tendon with immobilisation	Device: immobilisation duration; immobilisation duration of 2,4,6 week after suture of Achilles tendon

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
visual analogue scale (VAS)	VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain. VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score	The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
the Achilles tendon Total Rupture Score (ATRS)	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.	2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 2, 2021
• First Posted (Actual): July 9, 2021

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 2, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Duration of immobilisation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: LM2020252

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No