Analysis of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component

Study Overview
=================
Brief Summary
-----------------
This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.

Official Title
-----------------
Prospective, Multicenter Study to Assess Performance of a Tapered Porous Coated Stem and a Cementless Hemispherical Acetabular Component in Total Hip Arthroplasty

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis of the hip necessitating primary hip replacement, Suitability for straight cementless stem, Adult male and female under 75 years old, Ability to give informed consent , Patients who understand the conditions of the study and are willing to participate for the length of the prescribed follow-up. Exclusion Criteria: Off-label use of the Medacta Masterloc femoral component and MPACT acetabular component Post-traumatic deformity in the affected hip, Patient suffering from Inflammatory arthritis including rheumatoid arthritis, Patient suffering by congenital or developmental deformity, Severe osteoporosis, History of surgery in the affected hip, Perioperative fracture, Personality disorders (dementia, alcohol or drug abuse etc) suspected of making completion of the trial uncertain, Patients with a history of active infection Pregnant women or those seeking to become pregnant

Ages Eligible for Study
-----------------
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup<br>All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner. | Device: Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup.<br>* Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Harris Hip Score (HHS) | Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. | 
| Hip Disability and Osteoarthritis Outcome Score (HOOS) | Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. | 
| Oxford Hip Score (OHS) | Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. | 
| Veterans Rand 12 (VR-12) | Assessment of the improvement in your health using the Veterans Rand 12 | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. | 
| EuroQol 5 dimension (EQ-5D) | Assessment of the improvement in quality of life and joint movement using the EQ-5D | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic analysis | Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar. | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |