Two-layer Suturing of Achilles Tendon Ruptures

Recruiting

• Conditions: Achilles Tendon Rupture
• Interventions: Procedure: Two-layered suture repair

• Registration Number: NCT05717270
• Lead Sponsor: Bispebjerg Hospital

Brief 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

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-01-26
• Study First Submitted QC: 2023-02-03
• Study First Posted: 2023-02-08
• Study Start: 2023-05-23
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-23
• Last Update Posted: 2023-08-24
• Primary Completion: 2025-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective group	Two-layered suture repair	Acute Achilles tendon Rupture undergoing surgical repair.

Primary Outcome Measures

Name	Time	Method
Tendon length	One week after surgery.	The distance between the distal muscle fibers of the Soleus muscle and the posterior most superior part of the calcaneus.

Secondary Outcome Measures

Name	Time	Method
Muscle cross sectional area	6 months.	Gastrocnemius and soleus tendon and lower limb muscle cross-sectional area (mm2).
Patient perception	12 months	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.
Vascularisation	6 months.	Doppler flow (area in mm2)
Muscle architecture fascicle length	6 months.	Gastrocnemius and soleus muscle fascicle length (mm).
Muscle architecture pennation angle	6 months.	Gastrocnemius and soleus muscle pennation angle (°).
Tendon length Soleus	One week after surgery.	The distance (mm) between the distal muscle fibers of the gastrocnemius muscle and the posterior most superior part of the calcaneus.
Tendon length Triceps Surae	6 months.	The soleus and gastrocnemius tendon length (mm).
Plantar flexion function	6 and 12 months.	Heel-rise test

Trial Locations

Locations (1)

Institute of Sports Medicine Copenhagen; 🇩🇰 Copenhagen, NV, Denmark