Treatment Results After Acute Rupture of the Achilles Tendon.

Summary

To compare the end-results of three different methods of treatment of acute achilles tendon ruptures, it is necessary to establish identical rehabilitation protocols. Traditionally, early mobilization has been reserved for patients treated surgically and this may have unintentionally skewed treatment results. The investigators have therefore designed a prospective randomized trial performed as collaboration between Akershus University Hospital (Ahus), Oslo University Hospital (The Emergency Department), Østfold Hospital (Fredrikstad) and Drammen Hospital. The four institutions were chosen because of their geographical proximity and because they jointly have a substantial catchment area. Treatment is divided into three arms, and patients between 18 and 60 years of age sustaining first time achilles tendon ruptures will be invited to participate.

Conditions

• Rupture of Achilles Tendon

Interventions

PROCEDURE

Non-operative treatment

All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none. Patients randomized to non-operative treatment will have a cast applied within 3 days from injury.

PROCEDURE

Open surgery

All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.

PROCEDURE

Mini-invasive surgery

We will use the technique developed by Dr. Amlang and Professor Zwipp from Dresden, Germany. They have developed a protocol of mini-invasive surgery using specially adapted proprietary instruments. All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• Sykehuset Ostfold

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Hjelp24

  collaborator OTHER

• University Hospital, Akershus

  lead OTHER

Principal Investigators

• Ståle B Myhrvold, MD · University Hospital, Akershus

• Sigurd E Hoelsbrekken, PhD · University Hospital, Akershus

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2019-05-31

Completion

2019-05-31

Countries

• Norway

Study Locations