Achilles Tendon Elongation and Gait Pattern After Rupture.

NCT ID: NCT03543943

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-04
• Study Completion Date: 2020-12-10

Brief Summary

The objective of this study is to determine if Achilles tendon elongation and gait pattern differ between patients treated using an individualized treatment algorithm and patients treated as usual (two control groups; patients treated operatively and non-operatively).

The individualized treatment algorithm is based on ultrasonographic status of tendon overlap and Copenhagen Achilles Length Measure (1). 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.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Individualized treatment

The ruptured achilles tendon is examined by ultrasonography. If the overlap of the tendon ends is less than 25 % or the tendon is elongated 7 % or more the patient receives conventional open operative treatment. The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast after surgery. The ankle is held at maximal plantar flexion. Weight bearing is not allowed. After 3 weeks the cast is removed and the injured leg is transferred to a functional brace with 3 heel wedges. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Group Type: EXPERIMENTAL

Individualized treatment of Acute Achilles tendon rupture.

Intervention Type: PROCEDURE

The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of 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 \[1\]. 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.

Control group 1

For the patients allocated to non-operative treatment the injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Group Type: ACTIVE_COMPARATOR

Non-operative treatment

Intervention Type: PROCEDURE

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

Control group 2

The tendon is sutured with double fiberwire size 2 a.m. Kessler under prophylactic Dicloxacillin 2 g and in local anesthesia or alternatively popliteal or spinal block. The injured leg is placed in a circulated below the knee cast from the time of the first appointment in the Outpatients Department. The ankle is held at maximal, unforced plantar flexion. Weight bearing is not allowed and the patient should walk with the aid of crutches. After 3 weeks from initiated treatment in the Emergency Department the cast is removed in the Outpatients Department and the injured leg is transferred to a functional brace (Walker boot) with 3 heel wedges promoting 20 degrees plantar flexion over the ankle. The patient will follow standard functional rehabilitation and the follow-up evaluations.

Group Type: ACTIVE_COMPARATOR

Operative treatment

Intervention Type: PROCEDURE

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

Interventions

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 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 \[1\]. 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.

Intervention Type: PROCEDURE

Non-operative treatment

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Appointment in the Outpatients Department within 4 days of injury.
• Total Achilles tendon rupture.
• Initial treatment with split cast with the ankle in maximal plantar flexion must be started within 24 hours of injury.
• The patient must be expected to be able to attend rehabilitation and postexamination.
• The patient must be able to speak and understand Danish.
• The patient must be able to give informed consent.

Exclusion Criteria

• Rupture of the Achilles tendon either at the insertion on the calcaneus or at musculotendinous junction of the triceps surae.
• Previous rupture of the Achilles tendon in any of the two legs.
• Treated with fluoroquinolones or corticosteroids within the last 6 months.
• In medical treatment of diabetes.
• Suffers from rheumatic disease.
• Other conditions prior to the injury resulting in reduced function of any of the two legs.
• Contra-indication for surgery: severe arthrosclerosis with no palpable pulse in the foot, broken skin in the Achilles region of the injured leg.
• Inability to lie in prone position on the operating table.
• Terminal illness or severe medical illness: American Society of Anaesthesiologists physical status classification score higher than or equal to 3.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hvidovre University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maria Swennergren Hansen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria S Hansen, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Copenhagen University Hospital, Amager-Hvidovre

Locations

Department of Physiotherapy and Orthopedical surgery, Copenhagen University Hospital, Amager-Hvidovre

Copenhagen, Hvidovre, Denmark

Countries

Denmark

References

Barfod KW, Riecke AF, Boesen A, Hansen P, Maier JF, Dossing S, Troelsen A. Validation of a novel ultrasound measurement of achilles tendon length. Knee Surg Sports Traumatol Arthrosc. 2015 Nov;23(11):3398-406. doi: 10.1007/s00167-014-3175-2. Epub 2014 Jul 20.

Reference Type: BACKGROUND

PMID: 25038882 (View on PubMed)

Other Identifiers

Achilles HVH RCT

Identifier Type: -

Identifier Source: org_study_id