Nonoperative Treatment of Acute Achilles Tendor Rupture

Active, not recruiting

• Conditions: Achilles Tendon Rupture
• Interventions: Procedure: Operative treatment; Procedure: Nonoperative treatment

• Registration Number: NCT03704532
• Lead Sponsor: Central Finland Hospital District

Brief Summary

A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-01
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-10
• Study First Posted: 2018-10-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2024-08-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• acute achilles tendon rupture with clear onset of symptoms
• closed rupture
• resides in the catchment area of our hospital district

Exclusion Criteria

• avulsion fractures in the calcaneus
• unwillingness to participate
• inability to communicate using Finnish language

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operative treatment	Operative treatment	Patients having undergone an operative treatment of achilles tendon rupture
Nonoperative treatment	Nonoperative treatment	Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture

Primary Outcome Measures

Name	Time	Method
Rerupture rate	1 year	Rate rerupture of a healed tendon after the end of the intervention

Secondary Outcome Measures

Name	Time	Method
Foot inversion	1 year	Foot inversion angle in rest
Achilles tendon rupture score (ATRS)	1 year	Achilles tendon rupture score 1 year after the rupture
University of California, Los Angeles (UCLA) score	1 year	Patient activity 1 year after the rupture
Functional Score	1 year	Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100.
Heel-raise test	1 year	One leg heel-raise test while standing
Physical Activity Level	1 year	Patient activity 1 year after the rupture using the Tegner activity level scale which varies from 0 to 10. This scale that aims to provide a standardized method of grading work and sporting activities.
Foot flexion-extension	1 year	Foot flexion-extension angle in rest

Trial Locations

Locations (1)

Central Finland Hospital; 🇫🇮 Jyväskylä, Keski-Suomi, Finland