OsteoarthritisPhase 4NCT01180595
Roentgen Stereophotogrammetric Analysis (RSA) Trial Comparing Trabecular Metal Monoblock and Modular Tibial Components
A Phase 4 study testing Trabecular Metal Modular Tibial Total Knee Component and Trabecular Metal Monoblock Tibial Total Knee Component in people with Osteoarthritis, run by Dalhousie University at 1 site in Canada.
Trial summary
Total knee replacement is an effective option for treating chronic knee conditions that cause pain and functional impairment. Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures have been well documented. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Trabecular Metal Modular Tibial Total Knee Component and Trabecular Metal Monoblock Tibial Total Knee Component
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2011to Sep 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Who cannot join
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
Show all 12Show fewer
- Leg length discrepancy greater than 10 mm
- Active or prior infection
- Morbid Obesity (BMI > 40)
- Medical condition precluding major surgery
- Severe osteoporosis or osteopenia
- Neuromuscular impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Study Using Roentgen Stereophotogrammetric Analysis (RSA) to Compare the Fixation of the Trabecular Metal Monoblock and the Trabecular Metal Modular Total Knee Arthroplasties
Total knee replacement is an effective option for treating chronic knee conditions that cause pain and functional impairment. Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures have been well documented. Carefully monitored introduction of new implant designs through small, randomized trials using radiostereometric analysis (RSA) is gaining support. RSA is a radiographic technique that uses small tantalum balls implanted into the patient's bone to measure micromotion (<1 mm) at the bone - implant interface, something which is not possible to do reliably using regular x-ray techniques. The amount of micromotion that occurs within 2 years of surgery can be used to predict the long term survival of knee replacements. This provides a method for detecting inferior implant designs using only a small number of patients before release of these products into large clinical trials.
The study purpose is to utilize RSA to compare the migration patterns of the Trabecular Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop years and to determine what proportion of cases achieve adequate fixation. Secondary outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify any changes around the implant. Migration patterns will be compared to results obtained from previous studies of uncemented and cemented total knee arthroplasty components conducted at this centre.
Read more
Null Hypothesis: There is no significant difference in micromotion patterns of the TM arthroplasty components of the monoblock design and the modular design.
Alternative Hypothesis: There are significant differences in micromotion patterns between the tibial components of the monoblock design and the modular design.
This is a consecutive sample randomized control trial of patients undergoing total knee arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to identify the migration patterns of the tibial components of the implant. DEXA scanning will also be conducted to determine changes in the bone mineral density adjacent to the implant. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. Gait will be monitored and analyzed preoperatively and postoperatively throughout the duration of the trial.
- Conditions
- Osteoarthritis
- Being tested
- Trabecular Metal Modular Tibial Total Knee Component, Trabecular Metal Monoblock Tibial Total Knee Component
- Keywords
- osteoarthritis, arthroplasty, knee joint, radiography, surgery, Bone Density, Outcome Assessment (Health Care)
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabecular Metal Modular Tibial Total Knee ComponentDevice
The modular design of the Trabecular Metal Total Knee allows for increased options for physicians however, it is not clear how this modular feature will affect fixation since it may compromise some of the advantages of the original TM Monoblock tibial component.
Trabecular Metal Monoblock Tibial Total Knee ComponentDevice
| Study group | Role | What they receive |
|---|---|---|
| Modular | Other | Trabecular Metal Modular Tibial Total Knee Component Receives: Device: Trabecular Metal Modular Tibial Total Knee Component |
| Monoblock | Other | Trabecular Metal Monoblock Tibial Total Knee Component Receives: Device: Trabecular Metal Monoblock Tibial Total Knee Component |
What is being measured
The primary outcome is the main question the study is designed to answer.
micromotion of tibial component as measured with RSA
Measured: 2 years postoperative
Secondary outcomes (2)
Bone mineral density around the tibial component
Measured: 2 years postoperative
Subjective health outcome questionnaires - SF36, WOMAC, Oxford12 knee, Pain and Catastrophizing Scale, Standardized comorbidity questionnaire
Measured: 2 years 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 2010 (estimated)
- Study startFeb 2011
- Primary completionSep 2019
- Study completionSep 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Michael Dunbar, Dalhousie University
- Investigators
- Michael J Dunbar, MD PhD, Principal investigator, Dalhousie University and CDHA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180595
- Sponsor's protocol ID
- CDHA-RS/2011-010
- Status last verified
- Aug 2021
- First submitted
- 11 Aug 2010
- 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
- Randomized Control Study Using Roentgen Stereophotogrammetric Analysis (RSA) to Compare the Fixation of the Trabecular Metal Monoblock and the Trabecular Metal Modular Total Knee Arthroplasties
- ClinicalTrials.gov ID
- NCT01180595
- Acronym / sponsor ID
- CDHA-RS/2011-010
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, arthroplasty, knee joint, radiography, surgery, Bone Density, Outcome Assessment (Health Care)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Feb 2011
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 12 Aug 2010 (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.
Total knee replacement is an effective option for treating chronic knee conditions that cause pain and functional impairment. Significant improvements in quality of life, as measured by both disease specific and generic quality of life measures have been well documented. Carefully monitored introduction of new implant designs through small, randomized trials using radiostereometric analysis (RSA) is gaining support. RSA is a radiographic technique that uses small tantalum balls implanted into the patient's bone to measure micromotion (<1 mm) at the bone - implant interface, something which is not possible to do reliably using regular x-ray techniques. The amount of micromotion that occurs within 2 years of surgery can be used to predict the long term survival of knee replacements. This provides a method for detecting inferior implant designs using only a small number of patients before release of these products into large clinical trials.
The study purpose is to utilize RSA to compare the migration patterns of the Trabecular Metal(TM) Monoblock and the TM Modular Total Knee Arthroplasties during the first two postop years and to determine what proportion of cases achieve adequate fixation. Secondary outcome measures will be recorded to quantify changes in functional status of subjects after surgery and bone mineral density will be monitored to quantify any changes around the implant. Migration patterns will be compared to results obtained from previous studies of uncemented and cemented total knee arthroplasty components conducted at this centre.
Null Hypothesis: There is no significant difference in micromotion patterns of the TM arthroplasty components of the monoblock design and the modular design.
Alternative Hypothesis: There are significant differences in micromotion patterns between the tibial components of the monoblock design and the modular design.
This is a consecutive sample randomized control trial of patients undergoing total knee arthroplasty with the TM Monoblock and TM Modular Knee Arthroplasty systems utilizing RSA to identify the migration patterns of the tibial components of the implant. DEXA scanning will also be conducted to determine changes in the bone mineral density adjacent to the implant. Health status and functional outcome measures will be recorded to quantify functional status of subjects before surgery and at each follow-up interval. Gait will be monitored and analyzed preoperatively and postoperatively throughout the duration of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modular | Other | Device: Trabecular Metal Modular Tibial Total Knee ComponentTrabecular Metal Modular Tibial Total Knee Component |
| Monoblock | Other | Device: Trabecular Metal Monoblock Tibial Total Knee ComponentTrabecular Metal Monoblock Tibial Total Knee Component |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptomatic osteoarthritis of the knee indicating surgical intervention
- Between the ages of 21 and 80 inclusive
- Ability to give informed consent
Key exclusion criteria (12 listed)
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Extension lag greater than 10°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Prior arthroplasty, patellectomy or osteotomy with the affected knee
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 |
|---|---|---|
| Trabecular Metal Modular Tibial Total Knee ComponentThe modular design of the Trabecular Metal Total Knee allows for increased options for physicians however, it is not clear how this modular feature will affect fixation since it may compromise some of the advantages of the original TM Monoblock tibial component. | Device | Modular |
| Trabecular Metal Monoblock Tibial Total Knee Component | Device | Monoblock |
Primary outcome
micromotion of tibial component as measured with RSA
Time frame: 2 years postoperative
2 secondary outcomes
Bone mineral density around the tibial component
Time frame: 2 years postoperative
Subjective health outcome questionnaires - SF36, WOMAC, Oxford12 knee, Pain and Catastrophizing Scale, Standardized comorbidity questionnaire
Time frame: 2 years 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 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 J Dunbar, MD PhD principal investigator
Dalhousie University and CDHA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trabecular Metal Modular Tibial Total Knee Component and Trabecular Metal Monoblock Tibial Total Knee Component in people with 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 3 inclusion and 12 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
micromotion of tibial component as measured with RSA (time frame: 2 years 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 19 Aug 2021.