NCT04455490

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

1 month

First QC Date

June 25, 2020

Last Update Submit

July 1, 2020

Conditions

Keywords

Achilles tendon sutureDelayed wound healingEndoscopy

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

Delayed wound healing

Patients with delayed wound healing after Achilles tendon suture who were treated at Peking University Third Hospital

Other: Self-control

Interventions

We compared relevant scores of patients before and after surgery

Delayed wound healing

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

4 patients with delayed healing after Achilles tendon suture surgery who were treated at our institution, in the period from April 2008 to July 2019. The patients were 3 men and 1 woman, aged 39 to 60 years. Among them, 3 had surgery on the left Achilles tendon and 1 had surgery on the right Achilles tendon. The time from the first operation (Achilles tendon suture) to foreign body reaction ranged from 1 month to 5 months.

You may qualify if:

  • 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.

You may not qualify if:

  • The expected healing time of wounds with regular dressing changes is \<2 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

July 2, 2020

Study Start

March 18, 2020

Primary Completion

April 18, 2020

Study Completion

May 18, 2020

Last Updated

July 2, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations