Nonoperative Treatment of Acute Achilles Tendor Rupture

NCT ID: NCT03704532

Last Updated: 2024-02-13

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-01

Study Completion Date

2025-12-31

Brief Summary

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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

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Conditions

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Achilles Tendon Rupture

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Operative treatment

Patients having undergone an operative treatment of achilles tendon rupture

Operative treatment

Intervention Type PROCEDURE

Open surgical repair of tendon rupture

Nonoperative treatment

Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture

Nonoperative treatment

Intervention Type PROCEDURE

Nonoperative treatment with lower leg orthosis and functional rehabilitation

Interventions

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Operative treatment

Open surgical repair of tendon rupture

Intervention Type PROCEDURE

Nonoperative treatment

Nonoperative treatment with lower leg orthosis and functional rehabilitation

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Jyvaskyla

OTHER

Sponsor Role collaborator

Central Finland Hospital District

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juha Paloneva, MD, PhD

Role: STUDY_CHAIR

Central Finland Health Care District

Locations

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Central Finland Hospital

Jyväskylä, Central Finland, Finland

Site Status

Countries

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Finland

References

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Sukanen M, Khair RM, Reito A, Ponkilainen V, Paloneva J, Cronin N, Hautala AJ, Finni T. Early Predictors of Recovery From Nonoperatively Treated Achilles Tendon Rupture: 1 Year Follow-Up Study. Scand J Med Sci Sports. 2024 Jul;34(7):e14700. doi: 10.1111/sms.14700.

Reference Type DERIVED
PMID: 39010659 (View on PubMed)

Other Identifiers

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2U/2018

Identifier Type: -

Identifier Source: org_study_id

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