Overview

This trial is active, not recruiting.

Condition achilles tendon rupture
Treatments end to end suturation by krackow locking loop surgical technique with 2-fiber-wire suture, conservative treatment of achilles tendon rupture
Sponsor University of Oulu
Start date April 2009
End date May 2015
Trial size 60 participants
Trial identifier NCT02012803, Evo-rad-akilles-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (investigator)
Primary purpose treatment
Arm
(Experimental)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.
time frame: 18 months

Secondary Outcomes

Measure
Complications in treatment of achilles tendon rupture.
time frame: 18 months
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.
time frame: 18 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - 18-65 years, Clinical diagnosis of total achilles tendon rupture, ultrasonography controlled tendon ends reposition when ankle is in equinus/ plantar flexion. Exclusion Criteria: - earlier achilles tendon disorders, corticosteroid injections in achilles tendon, fluorokinolol-antibiotics in 2 years earlier, systemic corticosteroid medication, diabetes, peripheral arterial disease, more than 7 days old rupture, patient lives abroad or patient refused to participate.

Additional Information

Official title Conservative vs. Operative Treatment of Achilles Tendon Rupture, Prospective Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Oulu.