NoArc: Nonoperative Treatment of Acute Achilles Tendor Rupture

Sponsor

Central Finland Hospital District (Other)

Overall Status

Recruiting

CT.gov ID

NCT03704532

Collaborator

University of Jyvaskyla (Other)

200

Enrollment

Location

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Achilles Tendon Rupture	Procedure: Operative treatment Procedure: Nonoperative treatment

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 1, 2017

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Operative treatment Patients having undergone an operative treatment of achilles tendon rupture	Procedure: Operative treatment Open surgical repair of tendon rupture
Nonoperative treatment Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture	Procedure: Nonoperative treatment Nonoperative treatment with lower leg orthosis and functional rehabilitation

Arm

Intervention/Treatment

Operative treatment

Patients having undergone an operative treatment of achilles tendon rupture

Procedure: Operative treatment

Open surgical repair of tendon rupture

Nonoperative treatment

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

Procedure: Nonoperative treatment

Nonoperative treatment with lower leg orthosis and functional rehabilitation

Outcome Measures

Primary Outcome Measures

Rerupture rate [1 year]
Rate rerupture of a healed tendon after the end of the intervention

Secondary Outcome Measures

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.
University of California, Los Angeles (UCLA) score [1 year]
Patient activity 1 year after the rupture
Achilles tendon rupture score (ATRS) [1 year]
Achilles tendon rupture score 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.
Foot inversion [1 year]
Foot inversion angle in rest
Foot flexion-extension [1 year]
Foot flexion-extension angle in rest
Heel-raise test [1 year]
One leg heel-raise test while standing

Other Outcome Measures

Muscle strength [1 year]
Isometric plantar flexion strength
Gastrocnemius muscle cross-sectional area [1 year]
Lateral and medial gastrocnemius and soleus muscle area using ultrasound
Tendon length [1 year]
Achilles tendon length using ultrasound
Research ANd Development (RAND-36) quality of life [1 year]
Measurement of quality of life using RAND-36 questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Finland Hospital	Jyväskylä	Keski-Suomi	Finland	40620

Sponsors and Collaborators

Central Finland Hospital District
University of Jyvaskyla

Investigators

Study Chair: Juha Paloneva, MD, PhD, Central Finland Health Care District

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Central Finland Hospital District

ClinicalTrials.gov Identifier:

NCT03704532

Other Study ID Numbers:

2U/2018

First Posted:

Oct 12, 2018

Last Update Posted:

Aug 13, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Central Finland Hospital District

achilles tendon rupture

nonoperative treatment

functional rehabilitation

operative treatment

biomechanical measurements

Additional relevant MeSH terms:

Rupture

Study Results

No Results Posted as of Aug 13, 2021