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NCT05717270
Two-layer Suturing of Achilles Tendon Ruptures
Conditions: Achilles Tendon Rupture
Sex: All
Ages: 18 Years – 60 Years
Enrollment: 23
Sponsor: Bispebjerg Hospital
Location: Denmark
Summary
The purpose of the present study is to measure whether a new technique of double row suturing of a ruptured Achilles tendon will result in a normalization of the length of the Soleus part (primary outcome) and of the superficial Gastrocnemius part of the tendon (secondary outcome) one-week post-operative.
Results will be compared to that of a participants group that underwent the same operation but with a standard operative technique and the same rehabilitation regime recently completed (NCT04263493).The investigators hypothesize that the new suturing technique will result in an elongation of the Soleus part of the Achilles tendon (primary outcome) by 8.9 mm or less relative to the uninjured contralateral side one week (primary endpoint) after surgery compared to retrospective data from a recently completed randomized controlled trial
Eligibility Criteria
Inclusion Criteria:Diagnosed with a traumatic, complete mid-substance Achilles tendon ruptureManages transportation to/from the hospital on their ownPresented within 14 days from injuryAdult (18 to 60 years)Understands DanishExclusion Criteria:Other injuries affecting their lower limb functionsPrior Achilles contralateral tendon ruptureContraindications for MRIRe-ruptureSmokingSystemic diseases influencing tendon healingAnticoagulation treatmentInability to follow rehabilitation or complete follow-upsImmunosuppressive treatment including systemic corticosteroid treatment.
Source: ClinicalTrials.gov (NCT05717270). StuddyBuddy aggregates publicly available trial information.