Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings

Not Applicable

Active, not recruiting

• Conditions: Athletic Injuries; Rupture; Acute Disease; Achilles Tendon Rupture; Ultrasonography
• Interventions: Other: Non-surgical treatment; Procedure: Surgical treatment

• Registration Number: NCT04420832
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

Brief Summary

Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-17
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Study Start: 2020-08-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• acute achilles tendon rupture diagnosed less than 48 hours from injury
• mid-substance rupture

Exclusion Criteria

• previous achilles tendon rupture
• lower leg disability
• diabetes mellitus
• neurovascular disease
• immunosuppression
• non-Swedish speaker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-surgical treatment	Non-surgical treatment	Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy
Surgical treatment	Surgical treatment	Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy

Primary Outcome Measures

Name	Time	Method
Difference in functional outcome between patients treated surgically and non-surgically	24 months	The primary outcome will be a comparison of function by the heel-rise work test developed by Silbernagel et al. This is a validated set of tests measuring vertical jump, strength and endurance

Secondary Outcome Measures

Name	Time	Method
Achilles Tendon Rupture Score (ATRS)	24 months	Patient reported outcome measure (PROM) specific for achilles tendon rupture. Minimum value 0. Maximum value 100. Higher scores mean better outcome.
Physical Activity Scale (PAS)	24 months	PROM to measure overall physical activity. Minimum value 1. Maximum value 6. Higher scores mean a better outcome.
Ultrasonography (US)	24 months	Achilles tendon length - measured using US extended field of view

Trial Locations

Locations (1)

Department of Orthopedics; 🇸🇪 Göteborg, Västra Götalandsregionen, Sweden