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Completed

NCT Number: NCT02012803

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

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.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90220, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

Conservative treatment of achilles tendon rupture

Other

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

  1. Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.

    Time frame: 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 outcomes

  1. Complications in treatment of achilles tendon rupture.

    Time frame: 18 months

    Complications are re-rupture and postoperative infection.

  2. Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.

    Time frame: 18 months

    We study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2017
First posted
Dec 16, 2013
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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