- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455490
Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture
Study Overview
Detailed Description
Background: Delayed wound healing is a kind of postoperative complication of Achilles tendon suture. Conventional surgical approach is open surgery in order to clean the wound, which requires multiple dressing changes and involves a longer recovery period. We recently developed arthroscopic surgery for delayed wound healing after Achilles tendon suture. This therapy may be an alternative approach to open surgery.
Purposes: In this paper we evaluate the long-term efficacy of endoscopic surgery for delayed wound healing after Achilles tendon suture.
Patients and Methods: Clinical data of 4 patients with delayed wound healing after Achilles tendon suture who underwent endoscopic surgery from April 2008 to October 2017 at our institute were retrospectively analyzed. There were 3 males and 1 females with age of 39-60 years, the follow-up period was 8-43 months). All the patients had unilateral tendon rupture with 3 cases on the left and 1 cases on the right. Scores on Visual analogue scale(VAS) and the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot Scale were used. The postoperative outcome was evaluated on the basis of Victorian Institute of Sport Assessment-Achilles score and Achilles tendon total rupture score (ATRS).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Beijing
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Beijing, Beijing, China, 100191
- Peking University Third Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- The diagnostic criteria for delayed wound healing after Achilles tendon suture are met, namely the presence of skin necrosis, wound nonunion, or delayed wound healing.
Exclusion Criteria:
- The expected healing time of wounds with regular dressing changes is <2 weeks.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Delayed wound healing
Patients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital
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We compared relevant scores of patients before and after surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale
Time Frame: 8 months to 4 years after the surgery
|
Use Visual Analog Scale(VAS) to evaluate the pain recovery of patients who received endoscopic surgery.
VAS ranges from 0 to 10, higher scores mean a worse outcome.
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8 months to 4 years after the surgery
|
American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score
Time Frame: 8 months to 4 years after the surgery
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Use American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score(AOFAS) to evaluate the function recovery of patients who received endoscopic surgery.
AOFAS ranges from 0 to 100, higher scores mean a better outcome.
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8 months to 4 years after the surgery
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Victorian Institute of Sport Assessment-Achilles
Time Frame: 8 months to 4 years after the surgery
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Use Victorian Institute of Sport Assessment-Achilles(VISA-A) to evaluate the pain and movement recovery of patients who received endoscopic surgery.
VISA-A ranges from 0 to 100, higher scores mean a better outcome.
|
8 months to 4 years after the surgery
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Achilles tendon total rupture score
Time Frame: 8 months to 4 years after the surgery
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Use Achilles tendon total rupture score(ATRS) to evaluate the function and movement recovery of patients who received endoscopic surgery.
VISA-A ranges from 0 to 100, higher scores mean a better outcome.
|
8 months to 4 years after the surgery
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Tegner knee motion score
Time Frame: 8 months to 4 years after the surgery
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Use Tegner knee motion score to evaluate the sports ability of patients who received endoscopic surgery.
Tegner knee motion score ranges from 0 to 10, higher scores mean a better outcome.
|
8 months to 4 years after the surgery
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M2019492
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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