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

MicroPort Orthopedics Inc.1 site in 1 country25 target enrollmentMarch 9, 2017

ConditionsJoint Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Joint Disease
Sponsor: MicroPort Orthopedics Inc.
Enrollment: 25
Locations: 1
Primary Endpoint: Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

March 9, 2017

End Date

August 24, 2020

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MicroPort Orthopedics Inc.

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.

Time Frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative

Secondary Outcomes

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)