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

NCT ID: NCT04420832

Last Updated: 2024-05-29

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

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2027-08-31

Brief Summary

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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

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Conditions

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Achilles Tendon Rupture Athletic Injuries Ultrasonography Rupture Acute Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical treatment

Patients with a distance of 5 mm or more between tendon ends will be treated surgically and with physiotherapy

Group Type ACTIVE_COMPARATOR

Surgical treatment

Intervention Type PROCEDURE

Se above

Non-surgical treatment

Patients with a distance of less than 5 mm between tendon ends will be treated non-surgically and with physiotherapy

Group Type OTHER

Non-surgical treatment

Intervention Type OTHER

See above

Interventions

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Non-surgical treatment

See above

Intervention Type OTHER

Surgical treatment

Se above

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Katarina Nilsson Helander

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katarina Nilsson Helander, MD Ass Prof.

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Locations

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Department of Orthopedics

Gothenburg, Västra Götalandsregionen, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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ATR ultrasound study

Identifier Type: -

Identifier Source: org_study_id

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