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.
Patients admitted for surgery because of peroneal tendon injury will be randomized to one of two postoperative immobilization protocols. In group A the patients will use a cast for 6 weeks after surgery. In group B, the patients will use a cast for 3 weeks followed by a Air Stirrup for 3 weeks. The patients in group B will start unloaded range of motion 3 weeks after surgery. Both groups are allowed to weight-bear directly after surgery. The patients will be evaluated before and several times after surgery. Patient-reported outcome measures (PROMs) will be used to evaluate changes in patient quality of life between the two interventions. A biomechanical evaluation of the ankle, knee and hip kinematics and kinetics during walking, running and walking will also be performed before and repeatedly after surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Early functional training after 3 weeks using Air Stirrup compared to cast (standard protocol) after peroneal tendon surgery.
Cast 6 weeks after peroneal tendon surgery (standard protocol)
Department of Orthopedics
Gothenburg, Sweden
RECRUITINGNRS
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.
Calf circumference
The widest part of the calf will be measured.
Time frame: Preoperative and 6 months, 12 months and 24 months postoperative.
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.
Balance
The patients balance will be measured with stabilometry.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Electromyography (EMG)
EMG electrodes on the medial and lateral Gastrocnemius, Soleus and Tibialis Anterior, Quadriceps and trunk muscles will be attached on the patient in order to measure how the muscles are recruited during walking, running and jumping. Both healthy and injured sides will be analyzed. The electrical activity in the muscles will be evaluated. 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.
Cutting test
Cutting test will be performed according to standard module.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Heel-rise work test
Ankle plantar flexion endurance and heel-rise height will be evaluated using MuscleLab® during a heel-rise work test.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Background questions
During all follow-ups (including preoperative) the patients will fill out questionnaires. The questionnaires contain questions concerning, for example, fear of physical activity, fear of re-injuring oneself, satisfaction with the treatment, whether they have experienced complications, time on sick leave, etc.
Time frame: Preoperative and 3 weeks, 6 weeks, 3 months, 6 months, 12 months and 24 months postoperative.
The Self-Reported Foot and Ankle Score (SEFAS)
SEFAS is a questionnaire designed to evaluate disorders of the foot and ankle. The score covers different constructs that are not reported separately in subscales: pain, function including limitations of function, and other symptoms. Each of the 12 multiple-choice questions is scored from 0 to 4; thus, 0 total points represents the most severe disability and 48 represents normal function.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Foot and Ankle Outcome Score (FAOS)
The FAOS is a patient-reported foot- and ankle-specific questionnaire including 42 items in 5 subscales evaluating pain, symptoms, function of daily living (ADL), function in sport and recreation, and quality of life (QOL). Standardized answer options are provided, and each question is rated on a scale from 0 to 4. A score is calculated for each subscale after which raw scores for each subscale are transformed to a scale ranging from 0 to 100 and presented graphically as the FAOS profile. The minimum possible total score for each subscale is 0 points, a condition that represents the most severe disability, whereas the maximum of 100 points represents normal ankle function.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
Physical Activity Scale (PAS)
Physical activity questionnaire. A patient reported outcome used fot the purpose to evaluate the patients self estimated physical activity level. The scale is from 1 to 6 and the higher score, the better outcome.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.
EuroQol- 5 Dimension (EQ-5D)
Descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has three levels: no problems, some problems, and extreme problems. The EQ-5D index is a weighted total value of the score that is calculated after being adjusted for cultural differences. The answers given to EQ-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health.
Time frame: Preoperative and postoperative at 6 months, 12 months and 24 months.