Joint DiseaseTOPAZNCT02668211
Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
A study testing PROFEMUR Preserve Classic Femoral Components in people with Joint Disease and Osteoarthritis, run by MicroPort Orthopedics Inc. at 1 site in Canada.
Trial summary
MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone. Read more about this study
- Who is it for?
- Ages 21 to 76 years
- Conditions the study is for
- Joint Disease, Osteoarthritis
- What is being tested?
- PROFEMUR Preserve Classic Femoral Components
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2016to Dec 2019
- Phase
- Interventional
- 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 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a candidate for primary THA for osteoarthritis
- Subject is able to undergo primary THA procedure
- Subject is a candidate to be implanted with the specified combination of components
- Subject is willing and able to complete required study visits and assessments
- Subject is willing to sign the approved Informed Consent document
Who cannot join
- Subject has any of the following contraindications at the time of the implantation:
- 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 18Show fewer
- Subjects 76 years of age or older
- Subjects with post-traumatic arthritis in the affected hip
- Subjects with rheumatoid arthritis in the affected hip
- Subjects with hip dysplasia in the affected hip
- Subjects with prior arthroplasty of the affected hip
- Subjects that are morbidly obese (BMI > 35)
- Subjects that are immuno-suppressed
- Subjects with known or tested-positive allergy to metals
- Subjects currently enrolled in another clinical investigation which could affect the endpoints of this protocol
- Subjects unwilling or unable to sign the Informed Consent document
- Subjects with substance abuse issues
- Subjects who are incarcerated or have pending incarceration
Trial locations and contacts
1 site in 1 country.
About this study
MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.
- Conditions
- Joint Disease, Osteoarthritis
- Being tested
- PROFEMUR Preserve Classic Femoral Components
- Keywords
- osteoarthritis, radiostereometric analysis, correction of functional deformity, procedures, total hip arthroplasty, musculoskeletal diseases
- 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.
PROFEMUR Preserve Classic Femoral ComponentsDevice
Also called Total Hip Arthroplasty System
| Study group | Role | What they receive |
|---|---|---|
| PROFEMUR Preserve RSA | Other | Single cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components Receives: Device: PROFEMUR Preserve Classic Femoral Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.
Measured: 24 months
Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
Assessment of migration in each individual plane (x, y, and z), as measured in mm.
Measured: 24 months
Assess if migration pattern is greater than 0.2mm between 1 and 2 years
To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.
Measured: 24 months
Secondary outcomes (1)
Patient functional outcomes (HOOS)
The secondary objective is to determine if there is a significant difference in health status and functional outcomes (using the HOOS questionnaire) before and after total hip arthroplasty (THA) using the PROFEMUR® Preserve Femoral Components.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Not feasible - RSA machine not available. RSA images needed for study endpoints
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.
- More trials run by MicroPort Orthopedics Inc.The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- MicroPort Orthopedics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02668211
- Sponsor's protocol ID
- 14LJH002
- Acronym
- TOPAZ
- Status last verified
- Dec 2016
- First submitted
- 9 Nov 2015
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiostereometric Analysis (RSA) of the PROFEMUR® Preserve Classic Femoral Components
- ClinicalTrials.gov ID
- NCT02668211
- Acronym / sponsor ID
- TOPAZ / 14LJH002
- Conditions
- Joint Disease, Osteoarthritis
- Keywords
- osteoarthritis, radiostereometric analysis, correction of functional deformity, procedures, total hip arthroplasty, musculoskeletal diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not feasible - RSA machine not available. RSA images needed for study endpoints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MicroPort Orthopedics Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 29 Jan 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.
MicroPort Orthopedics (MPO) is conducting this study to investigate the primary stability of its PROFEMUR® Preserve Femoral Components using radiostereometric analysis (RSA). RSA allows precise measurement of micromotion around orthopedic implants and hence, may estimate long-term fixation to bone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PROFEMUR Preserve RSA | Other | Device: PROFEMUR Preserve Classic Femoral ComponentsSingle cohort of subjects prospectively implanted with PROFEMUR® Preserve Classic femoral components |
Who may qualify
- Ages
- 21 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is a candidate for primary THA for osteoarthritis
- Subject is able to undergo primary THA procedure
- Subject is a candidate to be implanted with the specified combination of components
- Subject is willing and able to complete required study visits and assessments
- Subject is willing to sign the approved Informed Consent document
Key exclusion criteria (18 listed)
- Subject has any of the following contraindications at the time of the implantation:
- 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);
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 |
|---|---|---|
| PROFEMUR Preserve Classic Femoral ComponentsAlso: Total Hip Arthroplasty System | Device | PROFEMUR Preserve RSA |
Primary outcome
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance.
Time frame: 24 months
Assessment of the quantity of migration to determine if the total migration of the stem and cup at 2 years post¬operatively are less than 1.2 mm and 2.6mm, and also less than 0.4mm. Assessment of continuous migration to determine if continuous migration, defined as 0.2mm of motion between 1 and 2 years as measured with RSA exists in the stem and cup.
Determine the migration patterns of the PROFEMUR® Preserve Classic stem with RSA
Time frame: 24 months
Assessment of migration in each individual plane (x, y, and z), as measured in mm.
Assess if migration pattern is greater than 0.2mm between 1 and 2 years
Time frame: 24 months
To determine if the wear rate device is substantially less than the scientifically accepted threshold of 0.1 mm/year for osteolysis. The outcomes will be compared to data from the literature, which states that motion greater than 0.2mm between 1 and 2 years suggests an implant is at risk for early loosening.
1 secondary outcome
Patient functional outcomes (HOOS)
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
Related trials for Joint Disease
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROFEMUR Preserve Classic Femoral Components in people with Joint Disease and Osteoarthritis, run by MicroPort Orthopedics Inc. at 1 site in Canada.
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 5 inclusion and 18 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: withdrawn, as of the sponsor's last update on 15 Dec 2016. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Assess the stability of the PROFEMUR® Preserve Classic stem with RSA to estimate its long-term performance. (time frame: 24 months). The study lists 3 primary outcomes in all. 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 15 Dec 2016.