Total Hip Arthroplasty
Conditions
Interventions
None listed
Sponsors
Amphia Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients undergoing total hip arthroplasty for osteoarthritis Patients with a BMI
Exclusion criteria
Exclusion criteria: Patients who have undergone a previous joint replacement surgery of the lower body in the past year Patients with a BMI>35
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage difference in load of the affected / operated leg compared to the unaffected leg, while walking at 3 km / h, at 4 weeks after the THA. This is determined by dividing the average ground reaction force during the stance phase of the operated leg by the mean ground reaction force during the stance phase of the non-operated leg. Primary outcome variable (s): The average ground reaction force (GRF) during the stance phase of the operated leg is divided by the average ground reaction force during the stance phase of the non-operated leg. The average of this is calculated on the number of steps that are run during 1 minute walk at 3 km / h. This primary outcome measure between the two groups is then compared with an unpaired t-test, assuming that the data will be normally distributed. This concerns the differences at the 4-week measurement moment. | — |
Secondary
| Measure | Time frame |
|---|---|
| As secondary outcome measures are assessed: * GRF symmetry at 8 and 12 weeks * Trunk sway on all 3 GRAIL moments * Pelvic lifts all 3 GRAIL moments * Hip and knee ROM during the walk on all 3 GRAIL moments * Internal / External rotation ROM of the hip on all 3 GRAIL moments * Hip abductor moment on all 3 GRAIL moments * EMG differences affected versus unaffected side during stance (gluteus maximus, gluteus medius and tensor fascia lata) on all 3 GRAIL moments * Cadence / step length on all 3 GRAIL moments * Gait width on all 3 GRAIL moments * Performance at obstacle avoidance task at all 3 GRAIL moments * Preferred walking speed on all 3 GRAIL moments * Change in Patient Reported Outcome MeasureS (PROMS) from pre-operative to 3 months (see 5.2.3: questionnaires) * Course in NumeRic Scal for pain (NRS) score Tertiary parameters * The use of tools during the recovery period * AEs and SAEs, which are requested during the GRAIL moments. Secondary outcome variable (s) With regard to the GRF symmetry at the other measurement moments (8 and 12 weeks): these will be calculated in the same way as the primary outcome measure and the difference between the groups will also be tested at any time with an unpaired t-test. Also the 'trunk sway', 'pelvic tilt', 'hip ROM sagittal plane', 'knee ROM sagittal plane', 'Internal / extarnal rotation ROM hip', 'Hip abductor moment', 'EMG differences between affected non-affected side' , 'step frequency / cadence', and 'gait width' are calculated as an average over 1 minute walk at 3 km / h. The preferred walking speed is determined by setting the treadmill with the patient in such a way that he / she walks the most comfortably. The performance on the obstacle avoidance task is evaluated by counting how often the patient walks on the projected surfaces in 4 minutes on the treadmill, which we again evaluate at 3 km / h. We will analyze the parameters in the two paragraphs above with two-way repeated measure | — |
Countries
Netherlands
Outcome results
None listed