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Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

Primary Purpose

Achilles Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
immobilisation duration
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 Duration of immobilisation

Eligibility Criteria

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

Inclusion Criteria:

patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.

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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

suture of Achilles tendon without immobilisation

suture of Achilles tendon with immobilisation

Arm Description

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
July 2, 2021
Last Updated
July 2, 2021
Sponsor
Peking University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04956614
Brief Title
Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Official Title
Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2021 (Actual)

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 novel Achilles tendon rupture repaired , patients were randomly divided into 4 groups according to immobilisation duration of 0, 2, 4, and 6 weeks, respectively. All patients underwent the same suture technique with a similar rehabilitation protocol and were examined clinically at 2, 4, 6, 8, 10, 12, 14, 16, 24, and 48 weeks to study the difference in efficacy among the groups.
Detailed Description
This prospective randomized controlled clinical study is designed to compare the treatment outcomes of different immobilisation duration by dividing the patients into four groups according to immobilisation duration of 0, 2, 4, and 6 weeks after a similar suture technique. The primary outcome was the time of return to light sports activity (LSA). Secondary outcomes included range of motion (ROM) and single-legged heel rise height (SHRH). Data on operation time, complications, visual analogue pain scale (VAS), American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot score, and Achilles tendon Total Rupture score (ATRS) were also collected. Demographic baseline data were analysed using one-way analysis of variance; outcome parameters were analysed using Kruskal-Wallis H test, and complications were analysed using Fisher's exact test. Statistical significance was considered at P ≤ 0.05. The inclusion criteria were patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique. The excluded criteria were patients with prior ATR and those without rehabilitation or follow-up outcomes. Other situations that affected patients' lower limb functions or tendon healing (e.g. autoimmune disease, diabetes mellitus, systemic corticosteroid treatment) were also excluded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendon Rupture
Keywords
Duration of immobilisation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
suture of Achilles tendon without immobilisation
Arm Type
Experimental
Arm Title
suture of Achilles tendon with immobilisation
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
immobilisation duration
Intervention Description
immobilisation duration of 2,4,6 week after suture of Achilles tendon
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. 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: patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique. 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.
Facility Information:
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery

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