Osteoarthritis, Rheumatoid Arthritis
Conditions
Brief summary
This is a single-centre, randomised, prospective clinical follow-up study to evaluate clinical outcome and gait analysis after total hip arthroplasty using the standard postero-lateral approach or the minimally invasive anterior approach.
Interventions
PROCEDUREMinimally Invasive Anterior Approach
Anterior minimally invasive surgery (AMIS)
PROCEDUREStandard postero-lateral approach
Sponsors
Medacta International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18-75 years at time of surgery. * Those presenting with primary or secondary osteoarthritis and/or rheumatoid arthritis of the hip. * Those deemed capable of giving informed consent, understanding the aims of the study and expressing willingness to comply with the post-operative review programme. * Patients who signed the study consent form prior to surgery.
Exclusion criteria
* Pregnant women or women who plan to conceive in the future. * Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems. * Those already treated by with a Total Hip Replacement (THR) (i.e. requiring a revision hip replacement). * Those with co-existent ipsilateral knee disease or back problems * Muscle contracture around the hip joint * Individuals who have undergone organ transplant. * Those with a known co-existent medical condition where death is anticipated within five years due to the pre-existing medical condition. * Individuals who have had a THR on the contra-lateral side within the 6 months. * Individuals who have undergone a THR on the contralateral side and whose outcome is considered unsatisfactory or not good. An unsatisfactory or poor result is defined as achieving a total UCLA score (including activity) \< 16 points. * Individuals requiring bilateral hip replacement. * Individuals whose body mass index (BMI; kg/m2) \>35. * Individuals with active or suspected infection or sepsis. * Individuals with renal failure and/or renal insufficiency. * Patients with severe forms of developmental dysplasia of the hip (DDH): Crowe types II, III, IV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare gait kinematics and the return to normalization of gait in patients that have undergone a THA via the direct anterior approach vs. the posterior approach | on average up to 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the improvement in quality of life and joint movement using the EuroQol-5D Score | pre-op, 1 year post-op | — |
| Assessment of patient's level of activity using the UCLA score | pre-op and 6 weeks, 6 months, 1 year after surgery | — |
| Radiological evaluation to assess the fixation and stability of femoral and acetabular components | pre-op and 6 weeks, 6 months, 1 year after surgery | — |
| Clinical assessment of patient using the Harris Hip Score | pre-op and 6 weeks, 6 months, 1 year after surgery | — |
| MRI evaluation | preop-1y after surgery | A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100) |
| Assessment of gait kinematics | 6 weeks, 12 weeks and 6 months | Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100) |
| Strength Testing | 6 weeks, 6 months and 1y after surgery | Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100) |
Countries
United Kingdom
Outcome results
None listed