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Trial record 3 of 499 for:    PreSERVE

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2016 by MicroPort Orthopedics Inc.
Sponsor:
Collaborator:
Orthopaedic Specialty Clinic of Spokane, PLLC
Information provided by (Responsible Party):
MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier:
NCT02865447
First received: July 1, 2016
Last updated: October 26, 2016
Last verified: October 2016
  Purpose
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.

Condition Intervention Phase
Joint Disease
Device: total hip arthroplasty implant
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by MicroPort Orthopedics Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hip functional outcomes will be assessed using the Harris Hip score. [ Time Frame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative ] [ Designated as safety issue: No ]
  • Implant loosening will be assessed by the presence of radiographic lucencies around the femoral stem. [ Time Frame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative ] [ Designated as safety issue: No ]
  • Implant survivorship of the femoral stem will be calculated. [ Time Frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative ] [ Designated as safety issue: No ]
  • Rate of complications will be assessed. [ Time Frame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 25
Study Start Date: January 2017
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: July 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
PRESERVE total hip arthroplasty implant
Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant
Device: total hip arthroplasty implant
Other Name: PROFEMUR PRESERVE

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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;
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02865447

Contacts
Contact: Leann Speering 901-290-5924 Leann.Speering@ortho.microport.com
Contact: Laura Sanchez 901-290-5279 Laura.Sanchez@ortho.microport.com

Locations
United States, Washington
Spokane Joint Replacement Center Not yet recruiting
Spokane, Washington, United States, 99218
Sponsors and Collaborators
MicroPort Orthopedics Inc.
Orthopaedic Specialty Clinic of Spokane, PLLC
  More Information

Responsible Party: MicroPort Orthopedics Inc.
ClinicalTrials.gov Identifier: NCT02865447     History of Changes
Other Study ID Numbers: 15-LJH-001 
Study First Received: July 1, 2016
Last Updated: October 26, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by MicroPort Orthopedics Inc.:
PRESERVE
dual energy x-ray absorptiometry
DEXA
DXA
total hip arthroplasty
PROFEMUR
bone mineral density
BMD
osteoarthritis
THA
musculoskeletal disease

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on December 02, 2016