Knee OsteoarthritisNCT03970460
Evaluation of Bone Mineral Density Changes Using Two Tibial Base Plate Designs in Primary Total Knee Arthroplasty in Young Patient
A study testing Primary TKA with cemented modular metal-backed tibial implant and Primary TKA with uncemented trabecular metal in people with Knee Osteoarthritis, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal.
Trial summary
Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient. Read more about this study
- Who is it for?
- Ages 45 to 59 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Primary TKA with cemented modular metal-backed tibial implant and Primary TKA with uncemented trabecular metal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 5 Aug 2011to 30 Dec 2020
- 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 45 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Tricompartmental osteoarthritis of the knee
- Age, under 60 years old at the time of surgery
- Stable health (the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history).
Who cannot join
- Diagnosis of inflammatory joint disease
- Diagnosis of osteonecrosis
- Infection; acute or chronic
- Any current metal hardware on the proximal 25 cm of the tibia
- History, remote or recent, of high tibial osteotomy or tibial plateau fracture
- Any collateral ligamentous instability in the affected knee
Show all 14Show fewer
- Contra lateral below knee or above knee amputation
- Ongoing Biphosphonate pharmacotherapy
- Presence of clinically significant disease of the cardiovascular, renal, hepatic, hematologic,respiratory, endocrine, neurological, gastrointestinal, genitourinary, immune systems or other medical condition which is not well controlled.
- Participants of a study who have received an investigational drug or device within the last 30 days
- Patients unwilling or unable to cooperate in a follow-up program
- Bone deficit (subchondral cyst)
- Previous contralateral Total Knee Arthroplasty (TKA), ORIF, HTO
- Patella deficiency needing grafting or preventing patella resurfacing
About this study
Official title: Randomized Clinical Evaluation of Bone Mineral Density Changes Using Two Tibial Base Plate Designs in Primary Total Knee Arthroplasty in Young Patients
Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient.
In a previous study submitted for publication, the investigators have looked at BMD in vivo after total knee replacement comparing two different tibial base plate designs in cemented and uncemented implants in terms of stiffness and modularity, and its effect on bone density changes, synovitis, osteolysis or survivorship. The investigators found a difference of 18% in bone mineral density favoring trabecular metal implant over cemented modular metal-back implant in patient between 55 and 75 years of age. The trabecular metal implant thus behaved as it was expected and preserved bone density in an elderly population.
No randomized clinical trial has looked at cemented titanium tibial insert to uncemented trabecular metal tibia insert in young population. In order to isolate stiffness as study variable, one would aim at randomizing a homogeneous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial baseplate, titanium versus trabecular metal. The trabecular metal implant is closer to human bone modulus of elasticity.
Read the detailed description
THE GOAL OF OUR STUDY IS TO
- Quantify the amount of bone remodeling 24 months after total knee arthroplasty using sequential dual-energy x-ray absorptiometry of the proximal tibia in younger and more active patients (less than 60 years of age).
- Evaluate the evolution of functional outcome over a 24 months period using sequential subjective and objective clinical evaluations using the Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and Sf-12 v2 in this cohort of patients.
- There is also an interest in looking at the activity level before and after the surgery (by using the Tegner Activity Level Scale and the UCLA Activity Level Scale) and to determine the ability to return to an active lifestyle and the impact on implant survival.
Two groups will be created:
Group 1: NexGen cemented modular metal-backed tibial implant (Titanium) Group 2: NexGen uncemented Trabecular Metal(TM) modular tibial implant A total of 88 patients will be recruited
- Conditions
- Knee Osteoarthritis
- Being tested
- Primary TKA with cemented modular metal-backed tibial implant, Primary TKA with uncemented trabecular metal
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary TKA with cemented modular metal-backed tibial implantDevice
Tibial implant will be done with a cemented implant
Primary TKA with uncemented trabecular metalDevice
Tibial implant will be done with a uncemented implant
| Study group | Role | What they receive |
|---|---|---|
| 45-54 y.o / cemented modular metal-backed tibial implant | Active comparator | This group will undergo a surgery for a knee arthroplasty following standard procedure at our center Receives: Device: Primary TKA with cemented modular metal-backed tibial implant |
| 55-59 y.o / cemented modular metal-backed tibial implant | Active comparator | This group will undergo a surgery for a knee arthroplasty following standard procedure at our center Receives: Device: Primary TKA with cemented modular metal-backed tibial implant |
| 45-54 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant Receives: Device: Primary TKA with uncemented trabecular metal |
| 55-59 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | This group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant Receives: Device: Primary TKA with uncemented trabecular metal |
What is being measured
The primary outcome is the main question the study is designed to answer.
DEXA Scan
This exam will quantify the amount of bone density at 24 months after total knee arthroplasty. DXA scan can provide accurate, high-quality measurements of periprosthetic bone mineral density (BMD) with minimal precision error and a low coeficient of variation ranging from 1.3% to 4.7%17.
Measured: 24 months post-op
KOOS (knee injury and osteoarthritis outcomes score )
The Index is self-administered and assesses the 5 subscales: pain (9 questions), other symptoms (7 questions), function in daily living (17 questions), function in sports and recreation (5) and knee related quality of live (4). All subscales are on 100, 100 being the best score, 0 the worst.
The total score is an average of all subscale
Measured: 2 years post-op
KSS (Knee Society Score)
The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 2 years post-op
Secondary outcomes (2)
The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2)
This self-administered generic health status measure is composed of 12 items measuring 3 major health attributes: functional status, well-being, and overall evaluation of health
Measured: 2 years post-op
Lyshom and Tegner
The Lysholm Scale currently consists of eight items that measure: pain (25 points), instability (25 points), locking (15 points), swelling (10 points), limp (5 points), stair climbing (10 points), squatting (5 points), and need for support (5 points). Every question response has been assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions, and may range from 0-100. Higher scores indicate a better outcome with fewer symptoms or disability.
Measured: 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start5 Aug 2011
- Primary completion30 Dec 2019
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet, CHU de Québec
- Responsible party
- Principal investigator, Michel Malo, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Michel Malo, ND, Principal investigator, Hôpital Sacré-Coeur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970460
- Sponsor's protocol ID
- PTG-Young
- Status last verified
- Feb 2020
- First submitted
- 27 May 2019
- Last updated
- 18 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Evaluation of Bone Mineral Density Changes Using Two Tibial Base Plate Designs in Primary Total Knee Arthroplasty in Young Patients
- ClinicalTrials.gov ID
- NCT03970460
- Acronym / sponsor ID
- PTG-Young
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Collaborators
- Zimmer Biomet, CHU de Québec
- Study start
- 5 Aug 2011 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 May 2019 (actual)
- 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.
Arthritic disease in people less than 60 years old is increasingly common. Younger, active individuals often present now to orthopaedic surgeons requiring treatment of knee osteoarthritis. Knee arthroplasty has been offered as a viable option to provide pain relief and improve function in the middle-aged patient.
In a previous study submitted for publication, the investigators have looked at BMD in vivo after total knee replacement comparing two different tibial base plate designs in cemented and uncemented implants in terms of stiffness and modularity, and its effect on bone density changes, synovitis, osteolysis or survivorship. The investigators found a difference of 18% in bone mineral density favoring trabecular metal implant over cemented modular metal-back implant in patient between 55 and 75 years of age. The trabecular metal implant thus behaved as it was expected and preserved bone density in an elderly population.
No randomized clinical trial has looked at cemented titanium tibial insert to uncemented trabecular metal tibia insert in young population. In order to isolate stiffness as study variable, one would aim at randomizing a homogeneous patient population undergoing total knee arthroplasty with implants of similar articular geometry designs with different tibial baseplate, titanium versus trabecular metal. The trabecular metal implant is closer to human bone modulus of elasticity.
Detailed description
THE GOAL OF OUR STUDY IS TO
- Quantify the amount of bone remodeling 24 months after total knee arthroplasty using sequential dual-energy x-ray absorptiometry of the proximal tibia in younger and more active patients (less than 60 years of age).
- Evaluate the evolution of functional outcome over a 24 months period using sequential subjective and objective clinical evaluations using the Knee Society Score (KSS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) and Sf-12 v2 in this cohort of patients.
- There is also an interest in looking at the activity level before and after the surgery (by using the Tegner Activity Level Scale and the UCLA Activity Level Scale) and to determine the ability to return to an active lifestyle and the impact on implant survival.
Two groups will be created:
Group 1: NexGen cemented modular metal-backed tibial implant (Titanium) Group 2: NexGen uncemented Trabecular Metal(TM) modular tibial implant A total of 88 patients will be recruited
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 45-54 y.o / cemented modular metal-backed tibial implant | Active comparator | Device: Primary TKA with cemented modular metal-backed tibial implantThis group will undergo a surgery for a knee arthroplasty following standard procedure at our center |
| 55-59 y.o / cemented modular metal-backed tibial implant | Active comparator | Device: Primary TKA with cemented modular metal-backed tibial implantThis group will undergo a surgery for a knee arthroplasty following standard procedure at our center |
| 45-54 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | Device: Primary TKA with uncemented trabecular metalThis group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant |
| 55-59 y.o / uncemented Trabecular Metal modular tibial implant | Experimental | Device: Primary TKA with uncemented trabecular metalThis group will undergo a surgery for a knee arthroplasty with a trabecular metal of the tibial implant |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Tricompartmental osteoarthritis of the knee
- Age, under 60 years old at the time of surgery
- Stable health (the patient should be able to undergo surgery and participate in a follow-up program based upon physical examination and medical history).
Key exclusion criteria (14 listed)
- Diagnosis of inflammatory joint disease
- Diagnosis of osteonecrosis
- Infection; acute or chronic
- Any current metal hardware on the proximal 25 cm of the tibia
- History, remote or recent, of high tibial osteotomy or tibial plateau fracture
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 |
|---|---|---|
| Primary TKA with cemented modular metal-backed tibial implantTibial implant will be done with a cemented implant | Device | 45-54 y.o / cemented modular metal-backed tibial implant, 55-59 y.o / cemented modular metal-backed tibial implant |
| Primary TKA with uncemented trabecular metalTibial implant will be done with a uncemented implant | Device | 45-54 y.o / uncemented Trabecular Metal modular tibial implant, 55-59 y.o / uncemented Trabecular Metal modular tibial implant |
Primary outcome
DEXA Scan
Time frame: 24 months post-op
This exam will quantify the amount of bone density at 24 months after total knee arthroplasty. DXA scan can provide accurate, high-quality measurements of periprosthetic bone mineral density (BMD) with minimal precision error and a low coeficient of variation ranging from 1.3% to 4.7%17.
KOOS (knee injury and osteoarthritis outcomes score )
Time frame: 2 years post-op
The Index is self-administered and assesses the 5 subscales: pain (9 questions), other symptoms (7 questions), function in daily living (17 questions), function in sports and recreation (5) and knee related quality of live (4). All subscales are on 100, 100 being the best score, 0 the worst. The total score is an average of all subscale
KSS (Knee Society Score)
Time frame: 2 years post-op
The original KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
2 secondary outcomes
The 12-item medical outcomes study short form health survey version 2.0 (SF-12v2)
Time frame: 2 years post-op
Lyshom and Tegner
Time frame: 2 years post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
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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.
Michel Malo, ND principal investigator
Hôpital Sacré-Coeur de Montréal
Questions about this trial
What is this clinical trial studying?
A study testing Primary TKA with cemented modular metal-backed tibial implant and Primary TKA with uncemented trabecular metal in people with Knee Osteoarthritis, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal.
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 14 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: status not confirmed, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
DEXA Scan (time frame: 24 months post-op). 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 18 Feb 2020.