Restoring Anatomy of Ruptured Achilles Tendon
ConditionAchilles Tendon Rupture
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
A new two-layer surgical technique
Procedure/SurgeryA 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
Other interventionStandard non-surgical treatment
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: NEWSURExperimental treatment 1 intervention
Group B: CONSEROther 1 intervention
Trial outcomes
Primary outcomes
1
The Achilles tendon Total rupture score (ATRS)
The Achilles tendon Total rupture score (ATRS) will be used. The ATRS is a patient-reported instrument with high reliability, validity, and sensitivity for measuring the outcome related to symptoms and physical activity after treatment in patients with a total Achilles tendon rupture. The scale is from 0-100. A score of 100 points indicates full function and no pain with lower scores indicating reduced function.
Time frame
At 1 yearSecondary outcomes
1
Hourly sporting activity
Data on activity level of sporting activities (h/week), if patients return to the same sport, and if patients return to the same job as prior to the injury will be obtained.
Time frame
1 year2
Patient satisfaction
Patient satisfaction regarding activities of daily living and sport participation will be evaluated using a 5-point Likert scale for satisfaction. With responses ranging from 1 (strongly dissatisfied) to 5 (strongly satisfied).
Time frame
1 year3
Tampa Scale of Kinesiophobia
Increased fear of movement can be a sequala after an Achilles tendon rupture. The Danish (and swedish in Sweden) version of the Tampa Scale of Kinesiophobia (TSK-11) will be used to assess fear of movement. The TSK-11 is scored on a 4-point Likert scale, with responses ranging from 1 (strongly disagree) to 4 (strongly agree). The lowest possible score, 11, denotes negligible or nonexistent kinesiophobia. The highest possible score, 44, denotes a severe fear of experiencing pain while moving.
Time frame
26 weeks & 1 year4
Heel-rise test
Heel-rise muscle function (height) and repetitions will be evaluated using a standardized heel-rise test.
Time frame
26 weeks & 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Bispebjerg Hospital
Lead sponsor
Copenhagen University Hospital, Hvidovre
Collaborator
Sahlgrenska University Hospital
Collaborator
Source ClinicalTrials.gov