Two-layer Suturing of Achilles Tendon Ruptures

NCT05717270 | Active Not Recruiting

• 1 other identifier: ATR_sutur_BFH
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Tendon length Soleus

  One week after surgery.

• Tendon length Triceps Surae

  6 months.

• Plantar flexion function

  6 and 12 months.

• Patient perception

  12 months

• Vascularisation

  6 months.

Study Arms (2)

Prospective group

Acute Achilles tendon Rupture undergoing surgical repair.

Procedure: Two-layered suture repair

comparison group

Patients group from a previous trial (NCT04263493).

Interventions

Two-layered suture repair PROCEDURE

The ruptured Achilles tendon will be sutured in two-layer.

Prospective group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients with diagnosed acute Achilles tendon rupture

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bispebjerg Hospital: lead

Study Sites (1)

Institute of Sports Medicine Copenhagen

Copenhagen, NV, 2400, Denmark

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project administrator

Study Record Dates

• First Submitted: January 26, 2023
• First Posted: February 8, 2023
• Study Start: May 23, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2026
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)