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Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

Primary Purpose

Tendon Injuries, Soft Tissue Injuries, Achilles Tendon Rupture

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Early loading on a training pedal
Tendon strain exercises
Early weight bearing
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tendon Injuries focused on measuring Achilles, Tendon, Loading, Rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon
  • Presented within 14 days from injury
  • 18-60 years old

Exclusion Criteria:

  • Inability to understand swedish
  • previous injured tendon
  • Diabetes mellitus
  • History of Rheumatoid disease
  • Treatment with steroids

Sites / Locations

  • University Hospital Linkoeping

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Early loading

Arm Description

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 weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.

The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).

Outcomes

Primary Outcome Measures

Modulus of Elasticity
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.

Secondary Outcome Measures

Tendon elongation
Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads
Modulus of Elasticity
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
Achilles tendon total rupture score (ATRS)
Patient reported outcome regarding function in their Achilles tendon
Maximal range of motion
The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.
Heel-rise
The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Plastic deformation of the tendon
Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.
Calf muscle circumference
Measurement of the circumference at the thickest part of the calf

Full Information

First Posted
June 10, 2016
Last Updated
August 3, 2021
Sponsor
Linkoeping University
Collaborators
University Hospital, Linkoeping
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1. Study Identification

Unique Protocol Identification Number
NCT02805751
Brief Title
Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures
Official Title
Mechanical Properties in Conservative Treated Achilles Tendon Ruptures With or Without Early Controlled Loading
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
November 2018 (Actual)
Study Completion Date
November 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Linkoeping University
Collaborators
University Hospital, Linkoeping

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to measure the mechanical properties of the tendon after conservative treated Achilles tendon ruptures with or without early controlled loading. This is done in a randomized trial and the mechanical properties are measured using roentgen stereometric analysis (RSA). The hypothesis is that early weightbearing improves mechanical properties of conservative treated Achilles tendon ruptures without causing elongation of the tendon.
Detailed Description
Treatment of Achilles tendon ruptures includes surgical repair or immobilization in an orthosis, followed by prolonged rehabilitation. Improved rehabilitation regimens still display imperfect recovery, with deficits such as persistent end-range muscle weakness, tendon elongation and incomplete return to pre-injury activity level. The underlying mechanisms are unknown, but are likely to involve molecular and cellular aspects of the early healing processes. Animal experiments have shown that short episodes of vigorous loading during tendon healing create a stronger tendon, and lead to less elongation than continuous loading. Early controlled training has also been shown to improve the material properties of surgically repaired tendons. However, more and more clinics now turn away from surgery and towards conservative treatment, while studies on rehabilitation mainly concern sutured tendons. It is therefore also important to understand how to best rehabilitate conservatively treated patients. The aim is to investigate the effect of early controlled loading on conservatively treated Achilles tendon ruptures. The patients (age 18-60 years of age) are treated conservatively by receiving a removable foam walker boot at the emergency department. The patients are thereafter called by the principal investigator and are asked if they want to participate in the study. Patients who are interested in participating in the study receive oral and in written information about the study of the principal investigator of the study (Pernilla Eliasson). After 2 weeks, the rupture is localized by ultrasound and 4 tantalum beads are implanted percutaneously in the proximal and distal part of the tendon. These beads are used for measurements of the mechanical properties of the tendon by using RSA. The patients are thereafter randomized to early controlled loading or control. All patients wear the foam walker boot for 7 weeks. Full weight-bearing is allowed as tolerated from the beginning. Both groups perform motion exercises outside the boot with 20 repetitions, 3 times per day as of 14 days after rupture. The patients in the early loading group are provided with a special training pedal where pedal resistance can be increased during the treatment period. The patients will use this pedal twice a day starting 2 weeks after rupture. After the initial 7 weeks, the patients are referred to physical therapists uninvolved in this research, but with the instruction to follow the regional rehabilitation guidelines for Achilles tendon ruptures. Mechanical properties of the tendon will be estimated by measuring tendon length, cross-sectional area (CSA) and stiffness at week 7, 19 and 52. The elastic modulus of the tendon at 19 weeks it the primary variable of this study. At week 7, both the elastic and plastic deformation will be measured. Tendon CSA will be evaluated using computer tomography (CT). Tendon elongation will be evaluated by RSA at week 2, 7, 19 and 52. Calf muscle circumference, passive and active range of motion in the ankle joint and a heel-raise test will be performed at week 19 and 52. The overall function will be assessed by the Achilles Tendon Rupture Score at 19 and 52 weeks. Complications and re-ruptures will be registered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendon Injuries, Soft Tissue Injuries, Achilles Tendon Rupture
Keywords
Achilles, Tendon, Loading, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
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 weight-bearing as tolerated from day 0. They are also instructed to perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
Arm Title
Early loading
Arm Type
Experimental
Arm Description
The patients in the early loading group are also allowed to have weight-bearing as tolerated from day 0 and perform tendon strain exercises 3 times each day from 2 weeks after the rupture. The patients in this group will also remove the walker twice a day and use a special training pedal for 5 weeks (until walker removal).
Intervention Type
Device
Intervention Name(s)
Early loading on a training pedal
Intervention Description
The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.
Intervention Type
Other
Intervention Name(s)
Tendon strain exercises
Intervention Description
The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
Intervention Type
Other
Intervention Name(s)
Early weight bearing
Intervention Description
The patients are allowed to bear weight as much as tolerated in the walker from day 1.
Primary Outcome Measure Information:
Title
Modulus of Elasticity
Description
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
Time Frame
19 weeks
Secondary Outcome Measure Information:
Title
Tendon elongation
Description
Tendon elongation will be evaluated using RSA and measurements of the distance between tantalum beads
Time Frame
2, 7, 19 and 52 weeks after rupture
Title
Modulus of Elasticity
Description
Modulus of elasticity will be measured using RSA and measurements of the distance between tantalum beads. A certain frame is used allowing us to apply a pedal to the forefoot and load it with weights. Tendon size will be measured using CT.
Time Frame
7 and 52 weeks after rupture
Title
Achilles tendon total rupture score (ATRS)
Description
Patient reported outcome regarding function in their Achilles tendon
Time Frame
19 and 52 weeks after rupture
Title
Maximal range of motion
Description
The maximun range of motion in the ankle joint will be measured in plantar and dorsiflexion.
Time Frame
19 and 52 weeks after rupture
Title
Heel-rise
Description
The number of heel-rises and the heel-rise height will be used for calculation of the heel-rise work.
Time Frame
19 and 52 weeks after rupture
Title
Plastic deformation of the tendon
Description
Plastic deformation will be measured using RSA and measurements of the distance between tantalum beads while the patient continues to have a load on the tendon for 3 minutes with a weight. Tendon size will be measured using CT.
Time Frame
7 weeks after rupture
Title
Calf muscle circumference
Description
Measurement of the circumference at the thickest part of the calf
Time Frame
19 and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Complete Achilles tendon rupture placed in the mid-substance of the Achilles tendon Presented within 14 days from injury 18-60 years old Exclusion Criteria: Inability to understand swedish previous injured tendon Diabetes mellitus History of Rheumatoid disease Treatment with steroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Aspenberg, MD, PhD
Organizational Affiliation
Linkoping University
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Linkoeping
City
Linkoping
State/Province
Ostergotland
ZIP/Postal Code
58729
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Controlled Loading on Conservative Treated Achilles Tendon Ruptures

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