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NCT Number: NCT05717270

Two-layer Suturing of Achilles Tendon Ruptures

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

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Institute of Sports Medicine Copenhagen

Copenhagen, NV, 2400, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Two-layered suture repair

Procedure

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

Primary outcomes

  1. Tendon length

    Time frame: 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 outcomes

  1. Tendon length Soleus

    Time frame: 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.

  2. Tendon length Triceps Surae

    Time frame: 6 months.

    The soleus and gastrocnemius tendon length (mm).

  3. Plantar flexion function

    Time frame: 6 and 12 months.

    Heel-rise test

  4. Patient perception

    Time frame: 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.

  5. Vascularisation

    Time frame: 6 months.

    Doppler flow (area in mm2)

  6. Muscle architecture fascicle length

    Time frame: 6 months.

    Gastrocnemius and soleus muscle fascicle length (mm).

  7. Muscle architecture pennation angle

    Time frame: 6 months.

    Gastrocnemius and soleus muscle pennation angle (°).

  8. Muscle cross sectional area

    Time frame: 6 months.

    Gastrocnemius and soleus tendon and lower limb muscle cross-sectional area (mm2).

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Registry information

Official study title

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

Acronym: ATRBFH

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 8, 2023
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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