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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02012803
Enrollment
60
Registered
2013-12-16
Start date
2009-04-30
Completion date
2017-12-31
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Achilles Tendon Rupture

Keywords

Achilles tendon rupture, treatment, elongation, operative treatment of achilles tendon rupture, conservative treatment of achilles tendon rupture

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.

Interventions

PROCEDUREEnd 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.

OTHERConservative 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.

Sponsors

University of Oulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective and objective results in conservative and operative treatment of Achilles tendon rupture.18 monthsSubjective 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

MeasureTime frameDescription
Complications in treatment of achilles tendon rupture.18 monthsComplications are re-rupture and postoperative infection.
Achilles tendon MRI-findings in operative and conservative treatment of achilles tendon rupture.18 monthsWe study calf muscle volume, achilles tendon volume, fat degeneration and achilles tendon elongation.

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026