NCT04663542

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

September 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

December 11, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 16, 2020

Last Update Submit

December 6, 2020

Conditions

Achilles Tendon Rupture

Keywords

immobilization durationopen surgeryearly rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • range of motion (ROM) recovery time

    from operation to 1-year follow-up after the surgery

  • recovery time of the single-legged heel rise height (SHRH)

    from operation to 1-year follow-up after the surgery

Other Outcomes (3)

  • visual analogue scale (VAS)

    2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

  • 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 Achilles tendon Total Rupture Score (ATRS)

    2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

Study Arms (4)

0-week immobilization

EXPERIMENTAL

0-week brace immobilization after the surgery will be conducted.

Procedure: immobilization duration

2-week immobilization

EXPERIMENTAL

2-week brace immobilization after the surgery will be conducted.

Procedure: immobilization duration

4-week immobilization

OTHER

4-week brace immobilization after the surgery will be conducted.

Procedure: immobilization duration

6-week immobilization

OTHER

6-week brace immobilization after the surgery will be conducted.

Procedure: immobilization duration

Interventions

immobilization durationPROCEDURE

brace immobilization duration after open surgery for Achilles tendon rupture

0-week immobilization2-week immobilization4-week immobilization6-week immobilization

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • acute closed single-legged complete Achilles tendon rupture
  • age of 18 to 60 years.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (2)

  • Cao Y, Li X, Cui Z, Lv Y, Si G. Open surgery and minimally invasive repair of acute Achilles tendon rupture: stratified outcomes based on immobilization duration in a prospective cohort study. J Orthop Surg Res. 2025 Jul 12;20(1):647. doi: 10.1186/s13018-025-06019-0.

    PMID: 40652259DERIVED

  • Cao Y, Gao S, Cui Z, Fu Y, Bai L, Si G, Fan J, Lv Y, Zhou F. Comparison of different immobilisation durations following open surgery for acute achilles tendon rupture: a prospective cohort study. J Orthop Surg Res. 2024 Aug 21;19(1):497. doi: 10.1186/s13018-024-04970-y.

    PMID: 39169350DERIVED

Study Officials

  • Jie Qiao, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Yang Lv, M.D.

CONTACT

+86-18513112060lvyang42@126.com

Xiangyu Xu, M.D.

CONTACT

+86-15210849431307542744@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

December 11, 2020

Study Start

September 1, 2020

Primary Completion

September 1, 2022

Study Completion

October 1, 2022

Last Updated

December 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)