RecruitingNot ApplicableNCT06723639

Restoring Anatomy of Ruptured Achilles Tendon

Effects of Restoring Achilles Tendon Anatomy After a Rupture: A Randomized Controlled Trial


Sponsor

Bispebjerg Hospital

Enrollment

120 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 67 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria9

  • Smoking
  • Diabetes
  • Other injuries affecting their lower limb function.
  • Contralateral Achilles tendon rupture.
  • Re-rupture.
  • Anticoagulation treatment.
  • Inability to follow rehabilitation or complete follow-up tests.
  • Immunosuppressive treatment, including systemic corticosteroid treatment.
  • Pregnant

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Interventions

PROCEDUREA 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.

OTHERStandard non-surgical treatment

Standard non-surgical treatment


Locations(3)

, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.

Copenhagen, Capital, Denmark

Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Capital, Denmark

Sahlgrenska University Hospital

Gothenburg, Sweden

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NCT06723639


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