A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement
Not Applicable
Completed
- Conditions
- Rheumatoid ArthritisOsteoarthritis
- Interventions
- Procedure: Minimally Invasive Anterior ApproachProcedure: Standard postero-lateral approach
- Registration Number
- NCT01106560
- Lead Sponsor
- Medacta International SA
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anterior Approach Group Minimally Invasive Anterior Approach (AMIS) Posterior Approach Group Standard postero-lateral approach (Posterior)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical assessment of patient using the Harris Hip Score pre-op and 6 weeks, 6 months, 1 year after surgery 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 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)
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)
Trial Locations
- Locations (1)
The Elective Orthopaedic Centre (EOC)
š¬š§Epsom, United Kingdom