Unilateral Primary Osteoarthritis of KneePhase 4NCT01764984
Bone Mineral Density Changes Under Two Tibial Components in Total Knee Arthroplasty
A Phase 4 study testing Total knee arthroplasty in people with Unilateral Primary Osteoarthritis of Knee, run by CHU de Quebec-Universite Laval at 3 sites in Canada.
Trial summary
Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Unilateral Primary Osteoarthritis of Knee
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 3 sitesCanada
- Study dates
- Nov 2005to Jan 2015
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tri-compartmental knee arthrosis
- 55 to 75 years of age
- Stable health condition
Who cannot join
- Inflammatory arthritis
- Osteonecrosis
- Infection
- Amputation (AK or BK)
- Biphosphonates
- Metal in the proximal tibia (25cm)
- History of fracture or osteotomy
- Ligament instability
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Hôpital Maisonneuve Rosemont
Montreal, Quebec, H1T 2M4
Hopital du Sacre-Coeur
Montreal, Quebec
Centre Hospitalier Universitaire de Québec
Québec, Quebec, G1R 2J6
About this study
Official title: Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.
Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. A recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. The material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. While introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. However, it introduced other modes of failures. Micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. Factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. Studies have described a significant decrease in postoperative Bone mineral density (BMD), adjacent to the implants, after total knee replacement. No study, to our knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial base plate designs. Direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. No randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.
Read the detailed description
Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all
- Being tested
- Total knee arthroplasty
- Keywords
- total knee arthroplasty, trabecular metal, bone mineral density
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyDevice
Also called NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer), NexGen Option Stemmed (Titanium) modular tibia (Zimmer).
Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
| Study group | Role | What they receive |
|---|---|---|
| Trabecular metal | Experimental | Primary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate. Receives: Device: Total knee arthroplasty |
| Titanium | Active comparator | Primary total knee arthroplasty is performed with cemented titanium traditional tibial base plate Receives: Device: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density (%) from baseline initial value
Evaluation of Bone Mineral Density using dual energy x-ray absorptiometry (DEXA) scan under tibial base plate implant after Total knee arthroplasty.
Measured: post-operative 7 to 10 days, 6,12,24 months
Secondary outcomes (4)
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Standardized clinical evaluation instrument specific to Total knee arthroplasty population.
Measured: Pre-operative, 6,12,24,60 months
number of study subject with implant loosening
Radiological evaluation of implant loosening according to Radiographic Knee Society Score at follow-up after total knee arthroplasty.
Measured: 12, 24, 60 months
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
Standardized clinical outcome instruments specific to total knee arthroplasty population.
Measured: pre-operative, 6,12,24,60 months
SF-36 score
Standardized General health evaluation and quality of life measuring instrument.
Measured: Pre-operative, 12,24,60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2013 (estimated)
- Study startNov 2005
- Primary completionSep 2009
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Primary Osteoarthritis of KneeStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Principal investigator, Étienne Belzile, CHU de Quebec-Universite Laval
- Investigators
- Etienne L Belzile, MD, Principal investigator, Centre Hospitalier Universitaire de Quebec - Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764984
- Sponsor's protocol ID
- 5.5.04.12
- Status last verified
- Feb 2015
- First submitted
- 17 Feb 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Evaluation of Bone Mineral Density Changes Under Non-cemented Trabecular Metal Tibial Component and Cemented Titanium Controls.
- ClinicalTrials.gov ID
- NCT01764984
- Acronym / sponsor ID
- 5.5.04.12
- Keywords
- total knee arthroplasty, trabecular metal, bone mineral density
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Nov 2005
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 10 Jan 2013 (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.
Osteoarthritis is a progressive disease afflicting to two thirds of Americans. Today, an estimated 43 million individuals have arthritis. By 2020, more than 59.4 million Americans will be affected by the disease. Despite the relative good track record of total knee replacement, it remains a biomedical device that can fail over time. A recent study looking at the current mechanisms of total knee replacement failures, listed polyethylene wear and osteolysis around implants. The material used for polyethylene insert as well as the conformity of articular surface of implants has been modified to decrease wear. While introducing modularity, the usage of metal backing in tibial base plates became obvious as it offered better stress distribution to the proximal tibial bone. However, it introduced other modes of failures. Micromotion has been demonstrated between the metal backing and the tibial liner, and produced backside polyethylene wear in 44% of implants at retrieval for revision. Factor influencing the surgeon's choice of implant include: reproductibility and longevity of results, technical difficulty of implantation, cost, and impact on bone stock. The modulus of elasticity of the tibial base plate has a direct effect on periprosthetic bone biology. Studies have described a significant decrease in postoperative Bone mineral density (BMD), adjacent to the implants, after total knee replacement. No study, to our knowledge, has looked at BMD in vivo after total knee replacement comparing different tibial base plate designs. Direct effect of changes in design on overall implant survival can be studied with randomized clinical trials isolating specific variables. No randomized clinical trial has looked at tibial insert stiffness and modularity, and it effect on bone density changes, synovitis, osteolysis or survivorship. In order to isolate stiffness and modularity as study variables, one would aim at randomizing an homogenous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial insert modularity and stiffness.
Detailed description
Number of patients: 80 Ages: 55 - 75 years old Sex: male and female Race: all
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabecular metal | Experimental | Device: Total knee arthroplastyPrimary Total Knee Arthroplasty is performed with a non cemented trabecular metal tibial baseplate. |
| Titanium | Active comparator | Device: Total knee arthroplastyPrimary total knee arthroplasty is performed with cemented titanium traditional tibial base plate |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tri-compartmental knee arthrosis
- 55 to 75 years of age
- Stable health condition
Key exclusion criteria (8 listed)
- Inflammatory arthritis
- Osteonecrosis
- Infection
- Amputation (AK or BK)
- Biphosphonates
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 knee arthroplastyAlso: NexGen LPS Monobloc (Trabecular Metal) tibia (Zimmer), NexGen Option Stemmed (Titanium) modular tibia (Zimmer).Total knee arthroplasty using parapatellar approach and postero-stabilized implants. | Device | Titanium, Trabecular metal |
Primary outcome
Change in Bone Mineral Density (%) from baseline initial value
Time frame: post-operative 7 to 10 days, 6,12,24 months
Evaluation of Bone Mineral Density using dual energy x-ray absorptiometry (DEXA) scan under tibial base plate implant after Total knee arthroplasty.
4 secondary outcomes
Western Ontario & McMAster University Osteoarthritis sCore (WOMAC)change in time.
Time frame: Pre-operative, 6,12,24,60 months
number of study subject with implant loosening
Time frame: 12, 24, 60 months
Knee injury and Osteoarthritis Outcome Score (KOOS) change in time.
Time frame: pre-operative, 6,12,24,60 months
SF-36 score
Time frame: Pre-operative, 12,24,60 months
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 4 Feb 2015.
Related trials for Unilateral Primary Osteoarthritis of Knee
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Unilateral Primary Osteoarthritis, Left 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.
Etienne L Belzile, MD principal investigator
Centre Hospitalier Universitaire de Quebec - Universite Laval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Total knee arthroplasty in people with Unilateral Primary Osteoarthritis of Knee, run by CHU de Quebec-Universite Laval at 3 sites 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 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 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Change in Bone Mineral Density (%) from baseline initial value (time frame: post-operative 7 to 10 days, 6,12,24 months). 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 4 Feb 2015.