Clinical trial NCT02865447: Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Joint Disease
Keywords: dual energy x-ray absorptiometry
DEXA
DXA
total hip arthroplasty
PROFEMUR
PRESERVE
bone mineral density
BMD
osteoarthritis
THA
musculoskeletal disease
Lead sponsor: MicroPort Orthopedics Inc.
Sponsor class: INDUSTRY
Collaborators: name: Orthopaedic Specialty Clinic of Spokane, PLLC
First posted: 2016-08-12
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
timeFrame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
Secondary outcomes:
measure: Hip functional outcomes will be assessed using the Harris Hip score.
timeFrame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
measure: Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem.
timeFrame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
measure: Implant survivorship of the femoral stem will be calculated.
timeFrame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
measure: Rate of complications will be assessed.
timeFrame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
measure: Hip functional outcomes will be assessed using the Forgotten Joint Score.
timeFrame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Spokane Joint Replacement Center
state: Washington
Study officials:
affiliation: Spokane Joint Replacement Center, Inc.
name: David Scott, MD
role: PRINCIPAL_INVESTIGATOR
References: