NCT02012803

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2009-04-01
• Primary completion: 2015-12-01
• Completion: 2017-12-01
• First posted: 2013-12-16
• Last updated: 2018-10-11

Locations

1 site across 1 country: Finland