Nonoperative Treatment of Acute Achilles Tendor Rupture

Achilles Tendon Rupture Clinical Trial

— NoArc  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03704532
• Other study ID #: 2U/2018
• Status: Active, not recruiting
• Start date: April 1, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: Central Finland Hospital District
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Rupture

Intervention

Procedure:
• Operative treatment
Open surgical repair of tendon rupture
• Nonoperative treatment
Nonoperative treatment with lower leg orthosis and functional rehabilitation

Locations

Country	Name	City	State
Finland	Central Finland Hospital	Jyväskylä	Keski-Suomi

Sponsors (2)

Lead Sponsor	Collaborator
Central Finland Hospital District	University of Jyvaskyla

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Muscle strength	Isometric plantar flexion strength	1 year
Other	Gastrocnemius muscle cross-sectional area	Lateral and medial gastrocnemius and soleus muscle area using ultrasound	1 year
Other	Tendon length	Achilles tendon length using ultrasound	1 year
Other	Research ANd Development (RAND-36) quality of life	Measurement of quality of life using RAND-36 questionnaire	1 year
Primary	Rerupture rate	Rate rerupture of a healed tendon after the end of the intervention	1 year
Secondary	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
Secondary	University of California, Los Angeles (UCLA) score	Patient activity 1 year after the rupture	1 year
Secondary	Achilles tendon rupture score (ATRS)	Achilles tendon rupture score 1 year after the rupture	1 year
Secondary	Functional Score	Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100.	1 year
Secondary	Foot inversion	Foot inversion angle in rest	1 year
Secondary	Foot flexion-extension	Foot flexion-extension angle in rest	1 year
Secondary	Heel-raise test	One leg heel-raise test while standing	1 year