NCT04912154

Brief Summary

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.

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
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

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

May 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 31, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 31, 2021

Last Update Submit

May 31, 2021

Conditions

Achilles Tendon Rupture

Keywords

traditional rehabilitation protocolaccelerated rehabilitation protocolultrasonic monitoring

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 (2)

Traditional rehabilitation protocol

EXPERIMENTAL

Traditional rehabilitation protocol after the surgery will be conducted

Procedure: Rehabilitation protocol

Accelerated rehabilitation protocol

ACTIVE COMPARATOR

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

Procedure: Rehabilitation protocol

Interventions

Rehabilitation protocolPROCEDURE

Rehabilitation protocol after open surgery for Achilles tendon rupture

Accelerated rehabilitation protocolTraditional rehabilitation protocol

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, China

RECRUITING

Study Officials

  • Jie Qiao, M.D.

    Peking University Third Hospital

    STUDY CHAIR

Central Study Contacts

Yang Lv, M.D.

CONTACT

+8682267010lvyang42@126.com

Yuan Cao, M.M.

CONTACT

+8682267010cy6415@126.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

May 31, 2021

First Posted

June 3, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

June 3, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)