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The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

Primary Purpose

Achilles Tendon Rupture

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rehabilitation protocol
Sponsored by
Peking University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Achilles Tendon Rupture focused on measuring traditional rehabilitation protocol, accelerated rehabilitation protocol, ultrasonic monitoring

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking University Third HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Traditional rehabilitation protocol

Accelerated rehabilitation protocol

Arm Description

Traditional rehabilitation protocol after the surgery will be conducted

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Range of motion (ROM) recovery time
The recovery time will be recorded when the ROM is similar to that of the uninjured side.
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.

Full Information

First Posted
May 31, 2021
Last Updated
May 31, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04912154
Brief Title
The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery
Official Title
A Prospective Randomized Controlled Clinical Trial on the Comparison of Traditional Rehabilitation Protocol and Accelerated Rehabilitation Protocol Under Ultrasonic Monitoring for Achilles Tendon Rupture
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
traditional rehabilitation protocol, accelerated rehabilitation protocol, ultrasonic monitoring

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional rehabilitation protocol
Arm Type
Experimental
Arm Description
Traditional rehabilitation protocol after the surgery will be conducted
Arm Title
Accelerated rehabilitation protocol
Arm Type
Active Comparator
Arm Description
Accelerated rehabilitation protocol under ultrasonic monitoring after the surgery will be conducted
Intervention Type
Procedure
Intervention Name(s)
Rehabilitation protocol
Intervention Description
Rehabilitation protocol after open surgery for Achilles tendon rupture
Primary Outcome Measure Information:
Title
The time of return to light sports activity
Description
When the patients are able to do jogging or rapid walk after the surgery, the time will be recorded.
Time Frame
From operation to 1-year follow-up after the surgery
Secondary Outcome Measure Information:
Title
Range of motion (ROM) recovery time
Description
The recovery time will be recorded when the ROM is similar to that of the uninjured side.
Time Frame
from operation to 1-year follow-up after the surgery
Title
Recovery time of the single-legged heel rise height (SHRH)
Description
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.
Time Frame
From operation to 1-year follow-up after the surgery
Other Pre-specified Outcome Measures:
Title
visual analogue scale (VAS)
Description
VAS pain score is from 0 to 10, the higher score demonstrate the more severe pain.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Title
American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score
Description
The AOFAS score ranges from 0 to 100, with a healthy hindfoot receiving 100 points.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery
Title
the Achilles tendon Total Rupture Score (ATRS)
Description
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.
Time Frame
2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks after the surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Lv, M.D.
Phone
+8682267010
Email
lvyang42@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Cao, M.M.
Phone
+8682267010
Email
cy6415@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Qiao, M.D.
Organizational Affiliation
Peking University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yang Lv, M.D.
Phone
+8601082267010
Email
lvyang42@126.com
First Name & Middle Initial & Last Name & Degree
Yuan Cao, M.M.
Phone
+8601082267010
Email
cy6415@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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The Efficacy of Different Rehabilitation Protocols After Achilles Tendon Rupture Surgery

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