Two-layer Suturing of Achilles Tendon Ruptures

Achilles Tendon Rupture Clinical Trial

— ATRBFH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05717270
• Other study ID #: ATR_sutur_BFH
• Status: Recruiting
• Start date: May 23, 2023
• Est. completion date: February 1, 2026

Study information

• Verified date: August 2023
• Source: Bispebjerg Hospital
• Contact: Anne-Sofie Agergaard, Postdoc
• Phone: 004529928343
• Email: anne-sofie.agergaard[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: February 1, 2026
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• Two-layered suture repair
The ruptured Achilles tendon will be sutured in two-layer.

Locations

Country	Name	City	State
Denmark	Institute of Sports Medicine Copenhagen	Copenhagen	NV

Sponsors (1)

Lead Sponsor	Collaborator
Bispebjerg Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Tendon length Triceps Surae	The soleus and gastrocnemius tendon length (mm).	6 months.
Secondary	Plantar flexion function	Heel-rise test	6 and 12 months.
Secondary	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
Secondary	Vascularisation	Doppler flow (area in mm2)	6 months.
Secondary	Muscle architecture fascicle length	Gastrocnemius and soleus muscle fascicle length (mm).	6 months.
Secondary	Muscle architecture pennation angle	Gastrocnemius and soleus muscle pennation angle (°).	6 months.
Secondary	Muscle cross sectional area	Gastrocnemius and soleus tendon and lower limb muscle cross-sectional area (mm2).	6 months.