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

NCT ID: NCT02865447

Last Updated: 2022-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-09
• Study Completion Date: 2020-08-24

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.

Conditions

Joint Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

PRESERVE total hip arthroplasty implant

Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant

total hip arthroplasty implant

Intervention Type: DEVICE

PROFEMUR PRESERVE total hip arthroplasty femoral stem

Interventions

total hip arthroplasty implant

PROFEMUR PRESERVE total hip arthroplasty femoral stem

Intervention Type: DEVICE

Other Intervention Names

PROFEMUR PRESERVE

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Orthopaedic Specialty Clinic of Spokane, PLLC

OTHER

Sponsor Role: collaborator

MicroPort Orthopedics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Spokane Joint Replacement Center, Inc.

Locations

Spokane Joint Replacement Center

Spokane, Washington, United States

Countries

United States

Other Identifiers

15-LJH-001

Identifier Type: -

Identifier Source: org_study_id