Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture

Wound Healing Clinical Trial

Official title:

Clinical Effect of Endoscopic Surgery for Delayed Wound Healing After Achilles Tendon Suture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04455490
• Other study ID #: M2019492
• Status: Completed
• Start date: March 18, 2020
• Est. completion date: May 18, 2020

Study information

• Verified date: July 2020
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study proposes endoscopic surgery for delayed wound healing after Achilles tendon suture which is a brand new treatment，and retrospectively analyzed the clinical data of 4 cases treated with this treatment. The analysis results of the clinical efficacy of the method can serve as a reference for clinical and surgical decision-making and prognosis assessment.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: May 18, 2020
• Est. primary completion date: April 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound Healing
• Wounds and Injuries

Intervention

Other:
• Self-control
We compared relevant scores of patients before and after surgery

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	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.	8 months to 4 years after the surgery
Primary	American Orthopaedic Foot and Ankle Society Ankle-Hindfoot Score	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.	8 months to 4 years after the surgery
Primary	Victorian Institute of Sport Assessment—Achilles	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
Primary	Achilles tendon total rupture score	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
Primary	Tegner knee motion score	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