Functional and Patient-reported Outcome After Peroneal Tendon Surgery and Different Immobilization Protocols
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region
About this trial
Patients with surgery of a peroneal tendon injury in Gothenburg, Sweden, will be randomized to one of two different postoperative protocols. Before and after surgery the patients will perform biomechanical evaluation and also fill out questionnaires including PROMs. All evaluations will be performed on both limbs.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Extensive surgery needed, such as for example heel osteotomy
Previous surgery in the affected area
Previous injury in the healthy foot/leg that impairs function
Neuromuscular disease
Trial design
Design model
Parallel
Treatments tested in this trial
Early Functional Training
Procedure/SurgeryEarly functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.
Standard protocol
Procedure/SurgeryCast 6 weeks after peroneal tendon surgery (standard protocol)
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: CastActive comparator 1 intervention
Group B: Cast + Air StirrupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
NRS
Pain will be graded using Numeric Rating Scale (NRS) ranging from 0 to 10, whereas 0 is corresponding to no pain and 10 is corresponding to the worst pain imaginable. Patients will be asked to select a corresponding number (0 - 10) to indicate the pain intensity they are experiencing during an average day, before taking the functional tests, during the tests and after taking the functional tests. In follow-ups that does not include any functional tests, the patients will only grade pain during an average day.
Time frame
Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.Secondary outcomes
1
Calf circumference
The widest part of the calf will be measured.
Time frame
Preoperative and 6 months, 12 months and 24 months postoperative.2
Range of motion
Range of motion (ROM) will be measured with inclinometer. Patients will be barefoot. ROM will be measured preoperative and postoperative after 6 weeks, 3 months, 6 months, 12 months and 24 months. The first two measurements after surgery (6 weeks, 3 months) will be carried out unloaded. The subsequent measurements (6 months, 12 months, 24 months) will be carried out loaded.
Time frame
Preoperative and postoperative at 6 weeks, 3 months, 6 months, 12 months and 24 months.3
Balance
The patients balance will be measured with stabilometry.
Time frame
Preoperative and postoperative at 6 months, 12 months and 24 months.4
Biomechanical evaluation
A biomechanical evaluation of the ankle, knee and hip kinematics and kinetics during walking, running, and jumping will be performed before and after surgery (6 months, 12 months and 24 months). For collection of the data, 16 Qualisys 7+ cameras (Qualisys AB, Gothenburg, Sweden) and 4 force plates will be used. 55 reflectors will be attached on the patient's body to be able to detect segmental movements. Kinetic data will be evaluated in power (watt) in ankle, knee and hip. Comparison will be performed between groups and limbs in power (LSI) - injured side/healthy side \*100 expressed in percent. The range in LSI is between 0-100% and the higher value, the better outcome.
Time frame
Preoperative and postoperative at 6 months, 12 months and 24 months.Sponsors and contacts
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Source ClinicalTrials.gov