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Clinical Trials/NCT02760784
NCT02760784CompletedNot Applicable

Medium Term Outcome of Nonoperative Dynamic Treatment of Acute Achilles Tendon Rupture: the Influence of Early Weight-bearing on Clinical Outcome: a Blinded, Randomized Controlled Trial.

Copenhagen University Hospital, Hvidovre1 site in 1 country37 target enrollmentStarted: January 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
37
Locations
1
Primary Endpoint
ATRS: Achilles Tendon Rupture Score

Study Overview

Brief Summary

A total of 56 patients completed a previous study regarding non-operative treatment for acute achilles tendon rupture. This study consists of an additional follow up after 4-5 years depending on original date of injury.

Detailed Description

30 patients suffering from acute Achilles tendon rupture was originally randomized to each arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in the final analysis, and invited to participate in this additional follow-up, 4-5 years after their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA: Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work, and tests of strength and stiffness in the ankle using a kinetic dynamometer.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Suffered acute Achilles tendon rupture from April 2011 to March 2012, and then referred to Copenhagen University Hospital Hvidovre.
  • •Participated and completed the original study.
  • •The patient must be able to speak and understand Danish, as well as be capable to give informed consent to participating.

Exclusion Criteria

  • •Terminal disease or serious illnesses with an ASA score of 3 or above.
  • •Any injury significantly influencing gate and function of the lower extremities other than re-rupture of the Achilles tendon.

Outcomes

Primary Outcomes

ATRS: Achilles Tendon Rupture Score

Time Frame: approximate 5 years

From initial test 6 and 12 months after injury, and now 4-5 years after.

Secondary Outcomes

  • return to sport and return to work(4-5 years after the initial injury)
  • Heel Raise Work(Test is performed once, 4-5 years after the initial injury)

Investigators

Sponsor
Copenhagen University Hospital, Hvidovre
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Rasmus Kastoft

Research Assistant

Copenhagen University Hospital, Hvidovre

Study Sites (1)

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