Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis

Study Overview
=================
Brief Summary
-----------------
Sponsor is conducting this post-market study to evaluate the clinical outcome and femoral bone mineral density (BMD) changes associated with the PROFEMUR® PRESERVE hip stem when used as indicated for primary total hip arthroplasty in patients with osteoarthritis of the hip joint.

Official Title
-----------------
A Dual Energy X-ray Absorptiometry (DXA) Evaluation of Bone Density Changes After Hip Replacement. Performance of the PROFEMUR® PRESERVE Hip Stem in Total Hip Arthroplasty, Two-Year Clinical and DXA Analysis

Conditions
-----------------
Joint Disease

Intervention / Treatment
-----------------
* Device: total hip arthroplasty implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in the study, subjects must meet all of the following criteria: Subject is minimum age 21 years, maximum age of 80 Subject is a candidate for primary THA for osteoarthritis of the hip Subject is able to undergo primary elective THA procedure Subject is willing and able to complete required study visits and assessments Subject is willing to sign the Institutional Review Board/Ethics Committee (IRB/EC) approved Informed Consent document. Exclusion Criteria: Subjects will be excluded if they meet any of the following criteria: Overt infection; Distant foci of infections (which may cause hematogenous spread to the implant site); Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram; Skeletally immature (less than 21 years of age at time of surgery); Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable; Neuropathic joints; Known Hepatitis or HIV infection; Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing Subjects with known osteoporosis of the affected hip Subjects with prior arthroplasty of the affected hip Subjects that are clinically obese (>40 body mass index [BMI]) Subjects with femoral dysplasia of the affected hip Subjects with trochanteric osteotomy of the affected hip Subject with inflammatory arthritis of the affected hip Subjects currently taking, or have taken within 12 months of enrollment, bisphosphonates, parathyroid hormone (PTH), fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect BMD in a substantial way Subjects with severe medical condition(s) that in the view of the investigator prohibits participation in the study Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol Subjects with known substance abuse issues Subjects who are incarcerated or have pending incarceration

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PRESERVE total hip arthroplasty implant<br>Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant | Device: total hip arthroplasty implant<br>* PROFEMUR PRESERVE total hip arthroplasty femoral stem<br>* Other names: PROFEMUR PRESERVE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem. |  | 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip functional outcomes will be assessed using the Harris Hip score. |  | Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative | 
| Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem. |  | 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative | 
| Implant survivorship of the femoral stem will be calculated. |  | 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative | 
| Rate of complications will be assessed. |  | Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative | 
| Hip functional outcomes will be assessed using the Forgotten Joint Score. |  | 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DXA, dual energy x-ray absorptiometry, DEXA, total hip arthroplasty, PROFEMUR, PRESERVE, bone mineral density, BMD, osteoarthritis, THA, musculoskeletal disease