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Individualized Treatment of Acute Achilles Tendon Rupture

NCT03525964 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2025-01-03

No results posted yet for this study

Summary

To asses the functional outcome after individualized treatment of acute achilles tendon rupture. The treatment is individualizes on the basis of ultrasonographic status of tendon overlap and Barfod's Ultrasonographic length measure. Patients are allocated for operative treatment if there the tendon overlap is less than 25 % or the tendon is elongated with 7% or more compared to the healthy, contralateral achilles tendon.

The study includes two control groups of non-operative and operative treatment.

Conditions

  • Achilles Tendon Rupture

Interventions

PROCEDURE

Individualized treatment of Acute Achilles tendon rupture.

The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the Achilles tendon and the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon and consist of the free tendon and the fascia \[1\]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. The cut-off at 7% elongation is determined for 75% sensitivity and 65% specificity of elongation.

PROCEDURE

Non-operative treatment

Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

PROCEDURE

Operative treatment

Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.

Sponsors & Collaborators

  • The Danish Rheumatism Association

    collaborator OTHER

  • Central Jutland Regional Hospital

    lead OTHER

Principal Investigators

  • Marianne T Vestermark, MD PhD · Central Jutland Regional Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2024-09-24
Completion
2024-09-24

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03525964 on ClinicalTrials.gov