Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-02-28
2027-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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NEWSUR
Participants in this group will receive a new two-layer surgical technique followed by a detailed rehabilitation regime.
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.
CONSER
Participants in this group will receive standard non-surgical treatment followed by a detailed rehabilitation regime.
Standard non-surgical treatment
Standard non-surgical treatment
Interventions
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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.
Standard non-surgical treatment
Standard non-surgical treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Presented within 14 days from injury.
* Understands and reads Danish.
* No contraindications for MRI.
Exclusion Criteria
* 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
18 Years
67 Years
ALL
No
Sponsors
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Copenhagen University Hospital, Hvidovre
OTHER
Sahlgrenska University Hospital
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
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Rikke Høffner
Post doc, PhD, PT
Locations
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, Copenhagen University Hospital Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark.
Copenhagen, Capital, Denmark
Copenhagen University Hospital, Amager-Hvidovre
Copenhagen, Capital, Denmark
Sahlgrenska University Hospital
Gothenburg, , Sweden
Countries
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Facility Contacts
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Other Identifiers
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H-24041516
Identifier Type: -
Identifier Source: org_study_id
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