Restoring Anatomy of Ruptured Achilles Tendon

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorBispebjerg Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Diagnosed with a complete mid-substance Achilles tendon rupture based on clinical exam, including Thompson/Matles test, by an experienced physician.

Presented within 14 days from injury.

Understands and reads Danish.

No contraindications for MRI.

Disqualifiers

Smoking

Diabetes

Other injuries affecting their lower limb function.

Contralateral Achilles tendon rupture.

Trial design

Treatments tested in this trial

  • A new two-layer surgical technique
  • Standard non-surgical treatment

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Bispebjerg Hospital

Lead sponsor

Copenhagen University Hospital, Hvidovre

Collaborator

Sahlgrenska University Hospital

Collaborator