Achilles Tendon Rupture
Conditions
Keywords
Achilles tendon rupture, MRI, Surgery, Restore anatomy, Heel-rise test, Rehabilitation
Brief 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.
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
Sponsors
Copenhagen University Hospital, Hvidovre
Sahlgrenska University Hospital
Bispebjerg Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Achilles tendon Total rupture score (ATRS) | At 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 1 year | 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). |
| Tampa Scale of Kinesiophobia | 26 weeks & 1 year | 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. |
| Heel-rise test | 26 weeks & 1 year | Heel-rise muscle function (height) and repetitions will be evaluated using a standardized heel-rise test. |
| Ultrasonography | 1 year | Muscle fascicle length, pennation angle and thickness of the medial gastrocnemius muscle will be measured with B-mode ultrasonography. Power doppler flow in the Achilles tendon will be recorded in the area with the highest visible Power Doppler activity. |
| Hourly sporting activity | 1 year | 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. |
| Plantarflexion muscle strength | 1 year | Maximal isometric plantar flexion muscle strength will be measured in 10-degree increments from 10 degrees of dorsiflexion to 20 degrees of plantarflexion with the knee in extension (soleus + gastrocnemius) and in flexion (primarily soleus) while seated (Biodex Multi-joint System 4 Pro, Biodex Medical Systems, USA) |
| Vertical jump performance | 1 year | For the countermovement jump, participants are instructed to stand on one leg with their arms folded across their chest, perform a maximal vertical jump, and aim to land in the same spot on the force plate. For the drop jump, participants stand on one leg with their arms folded across their chest on a 20cm box. They then jump down onto the force plate and, upon landing, perform a maximal vertical jump. Each participant will complete three repetitions on each leg for both tasks. For the hopping task, participants stand on one leg with their arms at their sides, as if jumping rope. They performed 25 rhythmic jumps at a self-selected pace, trying to remain in the same spot. Each participant completed two repetitions of the hopping task on each leg |
| Ankle joint range of motion (ATRA) | 26 weeks & 1 year | The passive ankle joint range of motion will be assessed as the Achilles tendon resting angle (ATRA) with the subject lying prone with the knee in full extension (ATRAext) and with the knee in 90 degrees of flexion (ATRAflex) bilaterally using a standard goniometer as previously described. The uninjured side will serve as an internal control. |
| Knee to wall test | 26 weeks & 1 year | Ankle dorsiflexion range of motion will be measured with the knee extended and knee flexed positions of the weight bearing lunge test bilaterally. |
| Magnetic resonance imaging (MRI) | 1 year | A 3D MRI of both Achilles tendons will be obtained. An axial 6-point DIXON sequence will also be applied to assess free fat fraction of the muscles.The uninjured side will serve as an internal control for all measures. |
Countries
Denmark, Sweden
Outcome results
None listed