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

NCT02865447 | Completed

• 1 other identifier: 15-LJH-001
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Keywords

dual energy x-ray absorptiometry; DEXA; DXA; total hip arthroplasty; PROFEMUR; PRESERVE; bone mineral density; BMD; osteoarthritis; THA; musculoskeletal disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

PRESERVE total hip arthroplasty implant

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

Device: total hip arthroplasty implant

Interventions

total hip arthroplasty implant DEVICE

PROFEMUR PRESERVE total hip arthroplasty femoral stem

Also known as: PROFEMUR PRESERVE

PRESERVE total hip arthroplasty implant

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• MicroPort Orthopedics Inc.: lead
• Orthopaedic Specialty Clinic of Spokane, PLLC: collaborator

Study Sites (1)

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

MeSH Terms

Conditions

Joint Diseases; Osteoarthritis; Musculoskeletal Diseases

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Arthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• David Scott, MD

  Spokane Joint Replacement Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2016
• First Posted: August 12, 2016
• Study Start: March 9, 2017
• Primary Completion: August 24, 2020
• Study Completion: August 24, 2020
• Last Updated: August 2, 2022

Record last verified: 2022-08

Locations

US (1)