Nonoperative Treatment of Acute Achilles Tendor Rupture

Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study

Sponsors

Lead Sponsor: Central Finland Hospital District

Collaborator: University of Jyvaskyla

Source 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.

Overall Status Recruiting
Start Date 2017-04-01
Completion Date 2023-08-31
Primary Completion Date 2021-08-31
Study Type Observational
Primary Outcome
Measure Time Frame
Rerupture rate 1 year
Secondary Outcome
Measure Time Frame
Physical Activity Level 1 year
University of California, Los Angeles (UCLA) score 1 year
Achilles tendon rupture score (ATRS) 1 year
Functional Score 1 year
Foot inversion 1 year
Foot flexion-extension 1 year
Heel-raise test 1 year
Enrollment 200
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Operative treatment

Description: Open surgical repair of tendon rupture

Arm Group Label: Operative treatment

Intervention Type: Procedure

Intervention Name: Nonoperative treatment

Description: Nonoperative treatment with lower leg orthosis and functional rehabilitation

Arm Group Label: Nonoperative treatment

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Juha Paloneva, MD, PhD Study Chair Central Finland Health Care District
Overall Contact

Last Name: Juha Paloneva, MD, PhD

Phone: +35814 269 3119

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Central Finland Hospital Juha Paloneva, Professor +358142693119 [email protected]
Location Countries

Finland

Verification Date

2018-11-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Operative treatment

Description: Patients having undergone an operative treatment of achilles tendon rupture

Label: Nonoperative treatment

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

Acronym NoArc
Patient Data Undecided
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

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