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

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

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.

Study Overview

• Status: Completed
• Conditions: Joint Disease
• Intervention / Treatment: Device: total hip arthroplasty implant

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99218
      • Spokane Joint Replacement Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the investigator's private orthopedic practice from among patients who require a total hip arthroplasty.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PRESERVE total hip arthroplasty implant; Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant	Device: total hip arthroplasty implant; PROFEMUR PRESERVE total hip arthroplasty femoral stem; Other Names: PROFEMUR PRESERVE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.
• Collaborators: Orthopaedic Specialty Clinic of Spokane, PLLC
• Investigators: Principal Investigator: David Scott, MD, Spokane Joint Replacement Center, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2017
• Primary Completion (Actual): August 24, 2020
• Study Completion (Actual): August 24, 2020

Study Registration Dates

• First Submitted: July 1, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: osteoarthritis; total hip arthroplasty; THA; DXA; bone mineral density; BMD; DEXA; dual energy x-ray absorptiometry; musculoskeletal disease; PROFEMUR; PRESERVE
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 15-LJH-001