Joint DiseaseNCT02865447
Evaluation of Bone Mineral Density Changes After Total Hip Replacement: A Two-Year Clinical and DXA Analysis
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Joint Disease
- What is being tested?
- total hip arthroplasty implant
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2017to 24 Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be recruited from the investigator's private orthopedic practice from among patients who require a total hip arthroplasty.
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Spokane Joint Replacement Center
Spokane, Washington, 99218
About this study
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
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
- Being tested
- total hip arthroplasty implant
- Keywords
- dual energy x-ray absorptiometry, DEXA, DXA, total hip arthroplasty, PROFEMUR, PRESERVE, bone mineral density, BMD, osteoarthritis, THA, musculoskeletal disease
- Medical subject headings
- Joint Diseases, Osteoarthritis, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total hip arthroplasty implantDevice
Also called PROFEMUR PRESERVE
PROFEMUR PRESERVE total hip arthroplasty femoral stem
| Study group | Role | What they receive |
|---|---|---|
| PRESERVE total hip arthroplasty implant | Subjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant Receives: Device: total hip arthroplasty implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bone mineral density (BMD), per dual energy x-ray absorptiometry (DXA) imaging, from standard and custom Gruen zones around the femoral stem.
Measured: 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.
Measured: 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.
Measured: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Implant survivorship of the femoral stem will be calculated.
Measured: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
Rate of complications will be assessed.
Measured: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Hip functional outcomes will be assessed using the Forgotten Joint Score.
Measured: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study start9 Mar 2017
- Primary completion24 Aug 2020
- Study completion24 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Orthopaedic Specialty Clinic of Spokane, PLLC
- Responsible party
- Sponsor
- Investigators
- David Scott, MD, Principal investigator, Spokane Joint Replacement Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02865447
- Sponsor's protocol ID
- 15-LJH-001
- Status last verified
- Aug 2022
- First submitted
- 1 Jul 2016
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02865447
- Acronym / sponsor ID
- 15-LJH-001
- Conditions
- Joint Disease
- Keywords
- dual energy x-ray absorptiometry, DEXA, DXA, total hip arthroplasty, PROFEMUR, PRESERVE, bone mineral density, BMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Orthopaedic Specialty Clinic of Spokane, PLLC
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 24 Aug 2020 (actual)
- Study completion
- 24 Aug 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PRESERVE total hip arthroplasty implant | – | Device: total hip arthroplasty implantSubjects to be prospectively implanted with the PROFEMUR PRESERVE total hip arthroplasty implant |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be recruited from the investigator's private orthopedic practice from among patients who require a total hip arthroplasty.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total hip arthroplasty implantAlso: PROFEMUR PRESERVEPROFEMUR PRESERVE total hip arthroplasty femoral stem | Device | PRESERVE total hip arthroplasty implant |
Primary outcome
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
5 secondary outcomes
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
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
Implant survivorship of the femoral stem will be calculated.
Time frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative
Rate of complications will be assessed.
Time frame: Preoperative, 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Hip functional outcomes will be assessed using the Forgotten Joint Score.
Time frame: 6 weeks Postoperative, 6 Months, 12 Months, and 24 Months Postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
Related trials for Joint Disease
Recruiting
Outpatient Physiotherapy vs. mHealth Exercise and Self-Management for Knee Osteoarthritis (MOKneeTOR)
Knee Osteoarthristis
RecruitingPhase 3
A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle
Chondral Defect, Articular Cartilage Defect
Not yet recruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
Not yet recruiting
Effects of Music During Walking on Pain and Muscle Activation in People With Chronic Pain Due to Knee Osteoarthritis
Knee Osteoarthritis
Recruiting
Radio- KO Radiotherapy for Knee Osteoarthritis Clinical Trial
Osteoarthritis, Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Scott, MD principal investigator
Spokane Joint Replacement Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by MicroPort Orthopedics Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 1 week Postoperative, 6 weeks, 6 Months, 12 Months, and 24 Months Postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.