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

U

University of Oulu

Status

Completed

Conditions

Achilles Tendon Rupture

Treatments

Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
Other: Conservative treatment of achilles tendon rupture

Study type

Interventional

Funder types

Other

Identifiers

NCT02012803
Evo-rad-akilles-2

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups

Operative treatment
Experimental group
Treatment:
Procedure: End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture
conservative treatment
Active Comparator group
Treatment:
Other: Conservative treatment of achilles tendon rupture

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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