NCT03704532

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 12, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 13, 2024

Status Verified

February 1, 2024

Enrollment Period

7.4 years

First QC Date

October 10, 2018

Last Update Submit

February 12, 2024

Conditions

Keywords

achilles tendon rupturenonoperative treatmentfunctional rehabilitationoperative treatmentbiomechanical measurements

Outcome Measures

Primary Outcomes (1)

  • Rerupture rate

    Rate rerupture of a healed tendon after the end of the intervention

    1 year

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Other Outcomes (4)

  • Muscle strength

    1 year

  • Gastrocnemius muscle cross-sectional area

    1 year

  • Tendon length

    1 year

  • +1 more other outcomes

Study Arms (2)

Operative treatment

Patients having undergone an operative treatment of achilles tendon rupture

Procedure: Operative treatment

Nonoperative treatment

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

Procedure: Nonoperative treatment

Interventions

Open surgical repair of tendon rupture

Operative treatment

Nonoperative treatment with lower leg orthosis and functional rehabilitation

Nonoperative treatment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • acute achilles tendon rupture with clear onset of symptoms
  • closed rupture
  • resides in the catchment area of our hospital district

You may not qualify if:

  • avulsion fractures in the calcaneus
  • unwillingness to participate
  • inability to communicate using Finnish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Hospital

Jyväskylä, Central Finland, 40620, Finland

Location

Related Publications (1)

  • 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.

Study Officials

  • Juha Paloneva, MD, PhD

    Central Finland Health Care District

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 12, 2018

Study Start

April 1, 2017

Primary Completion

August 31, 2024

Study Completion

December 31, 2025

Last Updated

February 13, 2024

Record last verified: 2024-02

Locations