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Completed

NCT Number: NCT03543943

Achilles Tendon Elongation and Gait Pattern After Rupture.

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.

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Key information

Conditions

Achilles Tendon Rupture

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Copenhagen, Hvidovre, DK-2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Individualized treatment of Acute Achilles tendon rupture.

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.

Non-operative treatment

Procedure

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

Operative treatment

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.

Primary outcomes

  1. Three-Dimensional Gait Analysis: Ankle peak power during push-off.

    Time frame: 12 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

Secondary outcomes

  1. Copenhagen Achilles Length Measure

    Time frame: 6 and 12 months after started treatment.

    The examination of both the total and the free part of the achilles tendon of both the injured and un-injured leg is performed. The total length of the tendon is defined under the description of the intervention. The free part of the achilles tendon is defined as the distance between the proximal border of calcaneus and the musculotendinous junction of the soleus muscle and the achilles tendon. The method will be used both diagnostically for the individualized treatment and as a secondary endpoint.

  2. Three-Dimensional Gait Analysis: Ankle peak power during push-off

    Time frame: 6 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

  3. Three-Dimensional Gait Analysis: Maximal dorsiflexion in the stance phase.

    Time frame: 6 and 12 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

  4. Three-Dimensional Gait Analysis: stiffness of the plantar flexor musculo-tendinous complex during dorsiflexion.

    Time frame: 6 and 12 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

  5. Three-Dimensional Gait Analysis: time of heel-lift

    Time frame: 6 and 12 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

  6. Three-Dimensional Gait Analysis: jumping up and down

    Time frame: 6 and 12 months after started treatment.

    Reflective markers placed on the patients skin with tape on specific anatomical locations, in total 19 markers. The reflective markers are being filmed by 8 infrared cameras hanging on the walls around the laboratory. Thereby, the joint angles during gait will be measured, and, in combination with the ground reaction forces from two force plates embedded in the floor, the joint moments and powers will be calculated.

  7. Balance measurement

    Time frame: 6 and 12 months after started treatment.

    The postural sway with patient standing on a force plate in the gait laboratory.

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Official study title

Achilles Tendon Elongation and Gait Pattern After Rupture: A Three Armed Randomized Controlled Trial Comparing an Individualized Treatment Algorithm vs. Operative or Non-operative Treatment.

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2018
Registry last updated
Mar 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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