Achilles Tendon Rupture Clinical Trial
Official title:
Measurement of Mechanical Properties of the Healing Achilles Tendon With or Without Early Weightbearing in a Clinical Randomized Trial
The purpose of this study is to measure the mechanical properties of healing Achilles
tendons in humans after early controlled weightbearing, compared with a control group in a
randomized, single-blinded trial. The mechanical properties are measured using
radiostereophotogrammetic x-rays (RSA).
Hypothesis: Early weightbearing improves mechanical properties of the healing Achilles
tendon.
Patient with an acute Achilles tendon rupture coming to the local emergency room are asked
to participate in our study. Patients have to be between 18 and 60 years and they must not
have any contraindications for surgical treatment.
Patients who are interested in participating in the study receive oral and in written
information about the study of the main investigator of the study (Thorsten Schepull).
Patients who then agree to participate in the study are registered for surgery. All patients
are operated the same way in local anaesthesia within 5 days after injury. We are going to
use a conventional open technique with a dorso-medial approach. Tendon ends are going to be
adapted with a resorbable suture and we are going to implant 2 Tantalum beads (size 0.8 mm)
in the distal part of the tendon and 2 Tantalum beads with the same size in the proximal
part. A short leg cast is going to be applied with the foot in the equinus position.
Randomization to early weightbearing or control group is done postoperatively
Group 1 (control group):
The short leg cast that is going to be applied during operation with the foot in the equinus
position is removed after 3.5 weeks and a new cast is applied with the ankle in a neutral
position for another 3.5 weeks. The new cast is removed after 3.5 weeks (cast treatment in
total 7 weeks). Physiotherapy starts after cast removal, following our previous hospital
routines. Full activity, including sports, is allowed after approximately 5 months.
We are going to perform RSA after 7 weeks (within 15 minutes after cast removal), after 19
weeks i.e. 12 weeks after cast removal, and after 52 weeks (12 months). A certain frame is
used allowing us to apply a pedal to the forefoot and load it with weights. The first force
applied to the pedal is 25 N and the second is 150 N. The same day CT scans of the injured
Achilles tendon are taken.
Group 2 (early weightbearing):
The cast from surgery i removed after 2 weeks and replaced by a removable Air Cast Walker.
The patient is provided with a special training pedal where pedal resistance can be
increased during the treatment period. The patients are using the Air Cast Walker for 5
weeks (cast treatment in total 7 weeks), but is supposed to remove the cast twice a day and
supposed to use the training pedal.
Follow-ups at 7 (cast removal), 19 and 52 weeks using RSA and CT are performed as in group
1.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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