The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

NCT ID: NCT04912154

Last Updated: 2021-06-03

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-06-01

Brief Summary

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This study is a prospective randomized controlled clinical study. After the Achilles tendon rupture repaired , patients were randomly divided into 2 groups, and the rehabilitation protocol was traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring , 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 rehabilitation protocols by dividing the patients into two groups-based on the traditional rehabilitation protocol and accelerated rehabilitation protocol under ultrasonic monitoring after a similar suture technique. 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.

Conditions

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Achilles Tendon Rupture

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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Traditional rehabilitation protocol

Traditional rehabilitation protocol after the surgery will be conducted

Group Type EXPERIMENTAL

Rehabilitation protocol

Intervention Type PROCEDURE

Rehabilitation protocol after open surgery for Achilles tendon rupture

Accelerated rehabilitation protocol

Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted

Group Type ACTIVE_COMPARATOR

Rehabilitation protocol

Intervention Type PROCEDURE

Rehabilitation protocol after open surgery for Achilles tendon rupture

Interventions

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Rehabilitation protocol

Rehabilitation protocol 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

+8682267010

Yuan Cao, M.M.

Role: CONTACT

+8682267010

Facility Contacts

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Yang Lv, M.D.

Role: primary

+8601082267010

Yuan Cao, M.M.

Role: backup

+8601082267010

Other Identifiers

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PekingUTH LYCY ATR

Identifier Type: -

Identifier Source: org_study_id

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