Two-layer Suturing of Achilles Tendon Ruptures

Study Overview
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Brief Summary
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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

Detailed Description
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This study is an ambidirectional cohort study with a retrospective part based on a recently completed trial (NCT04263493) and this prospective registered trial.

Official Title
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Two-layer Suturing of Achilles Tendon Ruptures - an Ambidirectional Cohort Study

Conditions
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Achilles Tendon Rupture

Intervention / Treatment
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* Procedure: Two-layered suture repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with a traumatic, complete mid-substance Achilles tendon rupture Manages transportation to/from the hospital on their own Presented within 14 days from injury Adult (18 to 60 years) Understands Danish Exclusion Criteria: Other injuries affecting their lower limb functions Prior Achilles contralateral tendon rupture Contraindications for MRI Re-rupture Smoking Systemic diseases influencing tendon healing Anticoagulation treatment Inability to follow rehabilitation or complete follow-ups Immunosuppressive treatment including systemic corticosteroid treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective group<br>Acute Achilles tendon Rupture undergoing surgical repair. | Procedure: Two-layered suture repair<br>* The ruptured Achilles tendon will be sutured in two-layer.<br>|
| comparison group<br>Patients group from a previous trial (NCT04263493). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon length | The distance between the distal muscle fibers of the Soleus muscle and the posterior most superior part of the calcaneus. | One week after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon length Soleus | The distance (mm) between the distal muscle fibers of the gastrocnemius muscle and the posterior most superior part of the calcaneus. | One week after surgery. | 
| Tendon length Triceps Surae | The soleus and gastrocnemius tendon length (mm). | 6 months. | 
| Plantar flexion function | Heel-rise test | 6 and 12 months. | 
| Patient perception | Achilles Tendon Total Rupture Score (ATRS). The ATRS consist of 10 items, with a total score range from 0 to 100, and a low score indicate more limitations in physical activity and worse symptoms. | 12 months | 
| Vascularisation | Doppler flow (area in mm2) | 6 months. | 
| Muscle architecture fascicle length | Gastrocnemius and soleus muscle fascicle length (mm). | 6 months. | 
| Muscle architecture pennation angle | Gastrocnemius and soleus muscle pennation angle (°). | 6 months. | 
| Muscle cross sectional area | Gastrocnemius and soleus tendon and lower limb muscle cross-sectional area (mm2). | 6 months. |