Comparison of Therapeutic Effect of Different Brace Fixed Time After Novel Achilles Tendon Rupture Surgery
1 other identifier
interventional
266
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 2, 2021
CompletedFirst Posted
Study publicly available on registry
July 9, 2021
CompletedJuly 9, 2021
July 1, 2021
2 years
July 2, 2021
July 2, 2021
Conditions
Keywords
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)
suture of Achilles tendon without immobilisation
EXPERIMENTALsuture of Achilles tendon with immobilisation
EXPERIMENTALInterventions
immobilisation duration of 2,4,6 week after suture of Achilles tendon
Eligibility Criteria
You may qualify if:
- patients aged 18 to 60 years with an acute closed single-legged complete ATR who underwent open surgery with our suture technique.
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, 100191, China
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
July 2, 2021
First Posted
July 9, 2021
Study Start
July 1, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2021
Last Updated
July 9, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share