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Restoring Anatomy of Ruptured Achilles Tendon

NCT06723639 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-04-15

No results posted yet for this study

Summary

The goal of this clinical trial is to investigate a new surgical approach to restore the anatomy of a ruptured Achilles tendon. We will use a new two-layer technique followed by rehabilitation and find out how it influence the patients clinical outcome, muscle and tendon structure, and function after one year and compare with a standard non-surgical approach followed by rehabilitation. Participants will be randomized to 1) NEWSUR: A new two-layer surgical technique followed by rehabilitation regime or 2) CONSER: A standard non-surgical treatment followed by rehabilitation .

We hypothesize that restoring the anatomy of the ruptured mid-substance Achilles tendon using a new two-layer surgery technique followed by rehabilitation will yield a more favorable patient reported outcome (ATRS) one year after rupture compared to standard non-surgical treatment followed by rehabilitation.

Conditions

  • Achilles Tendon Rupture

Interventions

PROCEDURE

A new two-layer surgical technique

A new double row suturing technique attempting to restore the length of the distinct soleus and gastrocnemius portions of the Achilles tendon.

OTHER

Standard non-surgical treatment

Standard non-surgical treatment

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER

  • Sahlgrenska University Hospital

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Denmark
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06723639 on ClinicalTrials.gov