Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02805751 |
| Other study ID # |
Early loading |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2015 |
| Est. completion date |
November 2019 |
Study information
| Verified date |
June 2016 |
| Source |
Linkoeping University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
