Nonoperative Treatment of Acute Achilles Tendor Rupture (NoArc)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Achilles Tendon Rupture
• Intervention / Treatment: Procedure: Operative treatment; Procedure: Nonoperative treatment

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Juha Paloneva, MD, PhD; Phone Number: +35814 269 3119; Email: juha.paloneva@ksshp.fi
• Study Contact Backup: Name: Aleksi Reito, MD, PhD; Phone Number: +358142693119; Email: aleksi@reito.fi

Study Locations

• Finland
  • Keski-Suomi
    • Jyväskylä, Keski-Suomi, Finland, 40620
      • Central Finland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients having sustained an acute achilles tendon rupture and referred for either operative or nonoperative treatment with functional rehabilitation at our institution.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rerupture rate	Rate rerupture of a healed tendon after the end of the intervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Activity Level	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.	1 year
University of California, Los Angeles (UCLA) score	Patient activity 1 year after the rupture	1 year
Achilles tendon rupture score (ATRS)	Achilles tendon rupture score 1 year after the rupture	1 year
Functional Score	Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100.	1 year
Foot inversion	Foot inversion angle in rest	1 year
Foot flexion-extension	Foot flexion-extension angle in rest	1 year
Heel-raise test	One leg heel-raise test while standing	1 year

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Finland Hospital District
• Collaborators: University of Jyvaskyla
• Investigators: Study Chair: Juha Paloneva, MD, PhD, Central Finland Health Care District

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 10, 2018
• First Posted (Actual): October 12, 2018

Study Record Updates

• Last Update Posted (Estimated): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: nonoperative treatment; operative treatment; achilles tendon rupture; functional rehabilitation; biomechanical measurements
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 2U/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No