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

Not Applicable

Completed

• Conditions: Achilles Tendon Rupture
• Interventions: Other: Conservative treatment of achilles tendon rupture; Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture

• Registration Number: NCT02012803
• Lead Sponsor: University of Oulu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2013-11-27
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-16
• Primary Completion: 2015-12
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conservative treatment	Conservative treatment of achilles tendon rupture	-
Operative treatment	End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture	-

Primary Outcome Measures

Name	Time	Method
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.	18 months	Subjective results consists of Rand-36 questionnaire and part of Leppilahti-scores questionnaire. Objective results consists of calf muscle isokinetic strength measurements and MRI-findings.

Secondary Outcome Measures

Name	Time	Method
Complications in treatment of achilles tendon rupture.	18 months	Complications are re-rupture and postoperative infection.
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.	18 months	We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland