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NCT04663542

The Efficacy of Different Immobilization Times After Achilles Tendon Rupture Surgery

NCT ID: NCT04663542

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Achilles Tendon Rupture

Keywords

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immobilization duration open surgery early rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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0-week immobilization

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

Group Type EXPERIMENTAL

immobilization duration

Intervention Type PROCEDURE

brace immobilization duration after open surgery for Achilles tendon rupture

2-week immobilization

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

Group Type EXPERIMENTAL

immobilization duration

Intervention Type PROCEDURE

brace immobilization duration after open surgery for Achilles tendon rupture

4-week immobilization

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

Group Type OTHER

immobilization duration

Intervention Type PROCEDURE

brace immobilization duration after open surgery for Achilles tendon rupture

6-week immobilization

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

Group Type OTHER

immobilization duration

Intervention Type PROCEDURE

brace immobilization duration after open surgery for Achilles tendon rupture

Interventions

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immobilization duration

brace immobilization duration after open surgery for Achilles tendon rupture

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jie Qiao, M.D.

Role: STUDY_CHAIR

Peking University Third Hospital

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Lv, M.D.

Role: CONTACT

Phone: +86-18513112060

Email: [email protected]

Xiangyu Xu, M.D.

Role: CONTACT

Phone: +86-15210849431

Email: [email protected]

Facility Contacts

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Yang Lv, M.D.

Role: primary

Xiangyu Xu, M.D.

Role: backup

References

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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.

Reference Type DERIVED

PMID: 40652259 (View on PubMed)

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.

Reference Type DERIVED

PMID: 39169350 (View on PubMed)

Other Identifiers

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81702127

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2018YFF0301100

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PekingUTH LY ATR

Identifier Type: -

Identifier Source: org_study_id