Two-layer Suturing of Achilles Tendon Ruptures

NCT ID: NCT05717270

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-23

Study Completion Date

2026-02-01

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.

Conditions

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Achilles Tendon Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Prospective group

Acute Achilles tendon Rupture undergoing surgical repair.

Two-layered suture repair

Intervention Type PROCEDURE

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

comparison group

Patients group from a previous trial (NCT04263493).

No interventions assigned to this group

Interventions

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Two-layered suture repair

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

Intervention Type PROCEDURE

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne-Sofie Agergaard

Project administrator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Sports Medicine Copenhagen

Copenhagen, NV, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ATR_sutur_BFH

Identifier Type: -

Identifier Source: org_study_id

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