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Achilles Tendon Rupture, Conservative vs. Operative Treatment: Prospective Randomized Controlled Trial

NCT02012803 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2018-10-11

No results posted yet for this study

Summary

The intention is to compare prospectively operative and conservative early functional rehabilitation protocol in treatment of total achilles tendon rupture. To compare these treatments, the investigators use 1998 published Leppilahti-score, Rand-36 quality of life-questionnaire and MRI. The Leppilahti-score includes both subjective and objective items (pain, stiffness, subjective calf muscle weakness, footwear restrictions, active range of motion between ankles, subjective result, isokinetic calf muscle strength). The investigators also study MRI-imaging for both legs and compare including achilles tendon elongation and muscle volume correlations to Leppilahti-score results between these two treatments. Follow-up time is 18 months.

Hypothesis is that operative treatment offers no benefit in comparison conservative treatment, with identical rehabilitation protocol.

Conditions

  • Achilles Tendon Rupture

Interventions

PROCEDURE

End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture

Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.

OTHER

Conservative treatment of achilles tendon rupture

Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2015-12-31
Completion
2017-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02012803 on ClinicalTrials.gov