Healing of Human Achilles Tendon Rupture

April 20, 2015 updated by: Pernilla Eliasson, Bispebjerg Hospital

Healing of Human Achilles Tendon Rupture: Loading Pattern After Surgical Repair to Achieve Optimal Mechanical Properties and Clinical Outcome

The overall aim of this project is to investigate the healing processes of human tendon after suturing a ruptured Achilles tendon, and more specifically to determine the optimal loading pattern of the tendon during the rehabilitation period to ensure complete and good recovery of tendon structure and function. The investigators hypothesize that restricting early weight bearing and only allowing for passive stretching in the early phase of tendon healing will ensure better tissue regeneration and thereby prevent chronic tendon elongation and improve tendon tissue recovery and the clinical outcome.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgical repair of Achilles tendon ruptures is known to significantly reduce the risk of re-rupture and to accelerate the time to return to activity compared with non-surgical treatments (1, 2). Although sutured, Achilles tendon rupture requires an extended rehabilitation period following surgery to function normally again. However, the currently available information on this post-operative treatment suggest that the currently available rehabilitation guidelines, which includes early weight bearing, does not accomplish optimal recovery of muscle-tendon function. It has been demonstrated that reduced capacity to perform heel-rises, diminished range of motion of the ankle joint, and reduced calf muscle mass is correlated with a delay in return to activity, and all of these factors could be related to elongation of the healing tendon (3). Importantly, it appears that preventing tendon elongation during rehabilitation improves the clinical outcome, but the actual mechanism for the elongation and thus how to prevent it remains unknown (4). With newly developed techniques in our laboratory we will determine the mechanical properties of human whole Achilles tendon, in vivo, which makes it possible to explore how tendons respond to the regimes following a suture repair and rehabilitation regime.

In contrast to the current rehabilitation regime after tendon surgery, which includes early high loading (weight bearing) already in the first weeks after surgery, we hypothesize that avoiding early weight bearing but allowing for early passive ankle joint range of motion (tissue strain with minimal loading) will prevent chronic tendon elongation, increase tendon stiffness, increase calf strength and muscle volume/thickness, and thus improve the long-term clinical outcome after tendon rupture in humans.

Patients with acute Achilles tendon ruptures will undergo a standardized suture repair (a.m. Kessler) using resorbable suture (Vicryl size 1) at Bispebjerg Hospital and be placed in a brace that inhibits ankle joint movement. During surgery, patients will get four tantalum beads with a diameter of 1.0 mm implanted with a venflon needle in the proximal and the distal stub of the tendon. Thereafter they will be randomized to three post-operative treatment regimes:

Control, range of motion or immobilized

From the currently available data (4, 5, 6) it is suggested that the brace is worn for 6 weeks after surgery in all three groups of the present experiment. The control group will be allowed partial weight-bearing from day 0 and full weight-bearing from week 4, toe rises after 16 weeks, jogging after 24 weeks and return to sports 34 weeks after. The two delayed weight-bearing groups (range motion group and immobilized group) will be restricted completely from weight-bearing initially (6 weeks), allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.

Study Type

Interventional

Enrollment (Anticipated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2400
        • Recruiting
        • Bispebjerg Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pernilla Eliasson, MSc, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 67 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury

Exclusion Criteria:

  • re-rupture
  • other injuries affecting their lower limb functions
  • systemic diseases influencing tendon healing
  • immunosuppressive treatment including systemic corticosteroid treatment
  • inability to follow rehabilitation or follow-ups.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
This constitutes the currently accepted regime and is therefore consider the control group (CTRL) with early range of motion and early weight bearing. The control group was allowed to have partial weight-bearing from day 0 and full weight-bearing from week 4. Furthermore, they were instructed in tendon strain exercise identical with the range of motion group.
Other: Range of motion
25 range of motion exercises of the ankle, 5 times per day.
Experimental: Range of motion
Early range of motion and delayed weight bearing (ROM). The range of motion group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks. In addition to this, the patients were instructed to perform tendon strain exercises, five times a day, from week 2. The exercises were performed by removing the foot from the brace and then perform light dorsal ankle movement, 25 repetitions/time, when sitting on a table.
Other: Range of motion
25 range of motion exercises of the ankle, 5 times per day.
Other: Delayed weight-bearing
No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks
Experimental: Immobilization
Delayed weight-bearing or range of motion (IMMOB). The immobilization group was restricted completely from weight-bearing until week 6, allowed partial weight-bearing after 6 weeks and full weight-bearing after 8 weeks.
Other: Delayed weight-bearing
No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tendon elongation
Time Frame: 2, 6, 12, 26 and 52 weeks after rupture
Tendon elongation will be evaluated using x-ray and measurements of the distance between tantalum beads
2, 6, 12, 26 and 52 weeks after rupture

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heel-rise
Time Frame: 26 and 52 weeks after rupture

The number of heel-rises and the heel-rise height will be used for

calculation of the heel-rise work.
26 and 52 weeks after rupture
Achilles tendon total rupture score (ATRS)
Time Frame: 12, 26 and 52 weeks after rupture
Patient reported outcome regarding function in their Achilles tendon
12, 26 and 52 weeks after rupture
Elastic modulus of the tendon
Time Frame: 6, 26 and 52 weeks after rupture
Tendon stiffness will be evaluated during a voluntary plantar flexion contraction where force and tendon elongation is measured using a force transducer and x-ray, respectively. Tendon size will be evaluated by MRI. Elastic modulus will be calculated based on stiffness and size of the tendon.
6, 26 and 52 weeks after rupture
Range of motion test
Time Frame: 26 and 52 weeks after rupture
Range of motion in the ankle will be measured.
26 and 52 weeks after rupture
Victorian Institute of Sport Assessment questionnaire - Achilles tendinopathy (VISA-A)
Time Frame: 12, 26 and 52 weeks after rupture
Patient reported outcome regarding pain in their Achilles tendon.
12, 26 and 52 weeks after rupture
Plantar flexion muscle strength
Time Frame: 26 and 52 weeks after rupture
Plantar flexion muscle strength will be measured during a maximal voluntary isometric contraction with ankle flexion at -10, 0˚ of dorsiflexion
26 and 52 weeks after rupture
Calf muscle size
Time Frame: 6, 26 and 52 weeks after rupture
Calf muscle size will be assessed using MRI.
6, 26 and 52 weeks after rupture
Tendon size
Time Frame: 6, 26 and 52 weeks after rupture
Tendon size will be assessed using MRI.
6, 26 and 52 weeks after rupture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

University of Copenhagen
Danish Council for Independent Research

Investigators

  • Study Director: Peter Magnusson, PT, DSc, PhD, Bispebjerg Hospital, University of Copenhagen
  • Study Director: Michael Kjaer, MD, PhD, Bispebjerg Hospital, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

April 16, 2015

First Submitted That Met QC Criteria

April 20, 2015

First Posted (Estimate)

April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

April 21, 2015

Last Update Submitted That Met QC Criteria

April 20, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBH100

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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