NCT06030908

Brief Summary

The purpose of this study is to evaluate the functional outcomes and sports ability after surgical treatment of insertional Achilles tendon tendinopathy using tendon detachment, debridement, and double-row anchor refixation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

September 13, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

August 28, 2023

Last Update Submit

November 27, 2023

Conditions

Achilles TendinopathyInsertional Achilles Tendinopathy

Keywords

insertionalAchilles Tendinopathysurgerysport

Outcome Measures

Primary Outcomes (1)

  • Return to sports Rate

    in percentage compared to preoperatively

    minimum 12 months from surgery to follow-up

Secondary Outcomes (6)

  • Number of sport units per week, sport disciplines practiced

    minimum 12 months from surgery to follow-up

  • Length of sport units

    minimum 12 months from surgery to follow-up

  • Range of motion after surgery

    minimum 12 months from surgery to follow-up

  • Subjective change of instability after surgery

    minimum 12 months from surgery to follow-up

  • Change of pain after surgery

    minimum 12 months from surgery to follow-up

  • +1 more secondary outcomes

Study Arms (1)

Study Population

Patients who underwent surgical reconstruction of the Achilles tendon insertion using a knotless, double-row anchor system.

Procedure: Reconstruction of Achilles tendon insertion

Interventions

Reconstruction of Achilles tendon insertionPROCEDURE

knotless double-row anchor fixation of the achilles tendon insertion

Study Population

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion between 01/2018 and 10/2021.

You may qualify if:

  • All patients who underwent reconstruction and double-row anchor refixation of the Achilles tendon insertion due to an insertional tendinopathy of the Achilles tendon.

You may not qualify if:

  • Lack of informed consent
  • Revision surgery
  • Patients who had another operation on the same leg during the same procedure or 6 months later

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ordensklinikum Linz, Barmherzige Schwestern Abteilung Orthopädie

Linz, 4010, Austria

Location

Study Design

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

Study Record Dates

First Submitted

August 28, 2023

First Posted

September 11, 2023

Study Start

September 13, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

November 29, 2023

Record last verified: 2023-11

Locations

AU(1)