A Randomised Trial Comparing Anterior Versus Posterior Approach in Total Hip Replacement

Study Overview
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Brief Summary
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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.

Official Title
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A Single Centre Prospective Randomised Controlled Clinical Trial Comparing Total Hip Arthroplasty Performed Either Through a Posterior Approach or a Direct Anterior Approach

Conditions
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Osteoarthritis, Rheumatoid Arthritis

Intervention / Treatment
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* Procedure: Minimally Invasive Anterior Approach
* Procedure: Standard postero-lateral approach


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Anterior Approach Group<br>(AMIS) | Procedure: Minimally Invasive Anterior Approach<br>* Anterior minimally invasive surgery (AMIS)<br>|
| Active Comparator: Posterior Approach Group<br>(Posterior) | Procedure: Standard postero-lateral approach<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Muscle strength will be assessed using the MIE digital myometer (from patient #50 to patient #100) | 6 weeks, 6 months and 1y after surgery | 
| MRI evaluation | A MRI examination will be used to detect any damage in the hip musculature and tendons (from patient #50 to patient #100) | preop-1y after surgery | 
| Assessment of gait kinematics | Comparison gait analysis Anterior vs Posterior groups at fixed time point (from patient #50 to patient # 100) | 6 weeks, 12 weeks and 6 months |