OsteoarthritisNCT01273324
Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
An observational study of Osteoarthritis, run by Dalhousie University at 1 site in Canada.
Trial summary
The dual mobility design concept for acetabular liners, as is used in the Restoration ADM Acetabular System, has been applied in various implants since its introduction by Gilles Bousquet in France in 1976. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ADM Cup
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2011to Dec 2019
- 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: Osteoarthritis of the hip
Who may be able to join
- Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Who cannot join
- Inflammatory arthritis
- BMI >40
- Post-traumatic arthritis of the hip
- Prior arthroplasty with the affected hip
- Hip dysplasia
- Active or prior infection
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study Using Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
The dual mobility design concept for acetabular liners, as is used in the Restoration ADM Acetabular System, has been applied in various implants since its introduction by Gilles Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been particularly lauded for low incidence of dislocations. However, the wear performance of this design concept has not been proven to date. As wear particles are a possible contributing factor in aseptic loosening, the assessment of wear and fixation is an important step in proving this implant design.
The proposed study will combine RSA and peri-prosthetic bone mineral density as well as outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation, polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular System.
Read the detailed description
Question 1: a) Do the implant components of the Restoration ADM Acetabular System achieve adequate fixation to the underlying bone? Null Hypothesis: There is no significant increase in micromotion of the implant components after 1 year indicating adequate long-term fixation at the implant - bone interface. Alternative Hypothesis: There is a significant increase in micromotion of of the implant components after 1 year indicating inadequate fixation at the implant - bone interface. b) What are the migration patterns (translations and rotations) of the Restoration ADM Acetabular System components during the first three years postoperatively? c) For what proportion of implants does migration continue to increase during the three year follow-up? d) Are inducible displacements, measured during weight-bearing follow-up exams, consistent over time and do they indicate that adequate fixation has been achieved? e) Are there significant differences in migration patterns (translations and rotations) between the Restoration ADM Acetabular System components and other implants previously studied with RSA and reported in the literature? Question 2: a) How much does the femoral head wear into the polyethylene liner?b)How much backside wear occurs on the polyethylene liner? c)How does the total wear compare to that with other implants previously reported in the literature? Question 3: Does the polyethylene liner demonstrate mobile bearing properties? Question 4: a) Are there changes over time in bone mineral density of peri-prosthetic bone with the Restoration ADM Acetabular System components? b) Where do changes in bone mineral density occur? Question 5: Does total hip arthroplasty using the Restoration ADM Acetabular System result in significant improvement in health status and functional outcome?
- Conditions
- Osteoarthritis
- Being tested
- ADM Cup
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADM CupDevice
Also called Styrker ADM Acetabular Cup
ADM Cup
| Study group | Role | What they receive |
|---|---|---|
| ADM | ADM Cup Receives: Device: ADM Cup |
What is being measured
The primary outcome is the main question the study is designed to answer.
RSA migration
Measured: 3 years
Secondary outcomes (2)
RSA wear
Measured: 3 years
Questionnaires
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dunbar, Dalhousie University
- Investigators
- Michael Dunbar, MD, FRCSC, PhD, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01273324
- Sponsor's protocol ID
- CDHA-RS/2012-079
- Status last verified
- Aug 2021
- First submitted
- 7 Jan 2011
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study Using Radiostereometric Analysis (RSA) and DEXA to Evaluate Fixation and Wear of the Restoration ADM Acetabular System
- ClinicalTrials.gov ID
- NCT01273324
- Acronym / sponsor ID
- CDHA-RS/2012-079
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 10 Jan 2011 (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.
The dual mobility design concept for acetabular liners, as is used in the Restoration ADM Acetabular System, has been applied in various implants since its introduction by Gilles Bousquet in France in 1976. Dual mobility cups have shown good clinical results and have been particularly lauded for low incidence of dislocations. However, the wear performance of this design concept has not been proven to date. As wear particles are a possible contributing factor in aseptic loosening, the assessment of wear and fixation is an important step in proving this implant design.
The proposed study will combine RSA and peri-prosthetic bone mineral density as well as outcome questionnaires to provide a complete in vivo evaluation of prosthesis fixation, polyethylene wear, and objective and subjective outcomes for the Restoration ADM Acetabular System.
Detailed description
Question 1: a) Do the implant components of the Restoration ADM Acetabular System achieve adequate fixation to the underlying bone? Null Hypothesis: There is no significant increase in micromotion of the implant components after 1 year indicating adequate long-term fixation at the implant - bone interface. Alternative Hypothesis: There is a significant increase in micromotion of of the implant components after 1 year indicating inadequate fixation at the implant - bone interface. b) What are the migration patterns (translations and rotations) of the Restoration ADM Acetabular System components during the first three years postoperatively? c) For what proportion of implants does migration continue to increase during the three year follow-up? d) Are inducible displacements, measured during weight-bearing follow-up exams, consistent over time and do they indicate that adequate fixation has been achieved? e) Are there significant differences in migration patterns (translations and rotations) between the Restoration ADM Acetabular System components and other implants previously studied with RSA and reported in the literature? Question 2: a) How much does the femoral head wear into the polyethylene liner?b)How much backside wear occurs on the polyethylene liner? c)How does the total wear compare to that with other implants previously reported in the literature? Question 3: Does the polyethylene liner demonstrate mobile bearing properties? Question 4: a) Are there changes over time in bone mineral density of peri-prosthetic bone with the Restoration ADM Acetabular System components? b) Where do changes in bone mineral density occur? Question 5: Does total hip arthroplasty using the Restoration ADM Acetabular System result in significant improvement in health status and functional outcome?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADM | – | Device: ADM CupADM Cup |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Osteoarthritis of the hip
Key inclusion criteria (4 listed)
- Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty
- Between the ages of 21 and 80 inclusive
- Patients willing and able to comply with follow-up requirements and self-evaluations
- Ability to give informed consent
Key exclusion criteria (8 listed)
- Inflammatory arthritis
- BMI >40
- Post-traumatic arthritis of the hip
- Prior arthroplasty with the affected hip
- Hip dysplasia
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 |
|---|---|---|
| ADM CupAlso: Styrker ADM Acetabular CupADM Cup | Device | ADM |
Primary outcome
RSA migration
Time frame: 3 years
2 secondary outcomes
RSA wear
Time frame: 3 years
Questionnaires
Time frame: 3 years
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 19 Aug 2021.
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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.
Michael Dunbar, MD, FRCSC, PhD principal investigator
Dalhousie University
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 Osteoarthritis, run by Dalhousie University 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 4 inclusion and 8 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 19 Aug 2021. 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 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?
RSA migration (time frame: 3 years). 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 19 Aug 2021.