Osteoarthritis, KneeNCT00405470
A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
A study testing Advance Medial Pivot Knee Arthroplasty in people with Osteoarthritis, Knee, run by Dalhousie University.
Trial summary
The purpose of this study is to determine whether this particular knee replacement is better than those already on the market. By participation, it will further refine the design of future total knee replacements and perhaps increase longevity. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Advance Medial Pivot Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Jun 2006
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary osteoarthritis of the knee
- Mono-articular disease (Charnley Modified Type A)
Who cannot join
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Greater than 10° of varus or 15° of valgus
- Extension lag greater than 10°
- Lateral or medial collateral ligament instability (> 10° varus/valgus)
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- Previous osteotomy about the knee
- Previous arthroplasty of the knee
- Previous patellectomy
- Leg length discrepancy greater than 10 mm
- Morbid obesity (obesity that results in significant systemic problems)
About this study
The purpose of this study is to determine whether this particular knee replacement is better than those already on the market. By participation, it will further refine the design of future total knee replacements and perhaps increase longevity.
Read the detailed description
Joint arthroplasty is an effective surgical intervention, however prosthetic survivorship is finite. New or modified prosthetic components are routinely introduced, partly in an effort to improve survivorship. When new technologies emerge for total knee replacement it is not always evident that they are an improvement over existing options. This determination requires long-term follow-up studies. Conventional studies require a large number of patients and approximately 10 years of follow-up. By using RSA to measure micromotion of prostheses over time problems can be elucidated with a much smaller sample over a shorter time period. RSA involves using tantalum markers (0.5-1.0 mm beads inserted in the bone and prosthesis during surgery) to measure motion in subsequent bi-planar x-rays of the joint. The relatively new Medial Pivot Knee (ADVANCE Knee) theoretically reproduces the natural kinematics of the knee but it is unclear what effect this design may have on the forces applied to the tibial component-bone interface. The amount of micromotion of the tibial component is directly related to the amount of force exerted on it and inversely related to its fixation. In this study we propose to compare in vivo micromotion at the tibial component-bone interface with the ADVANCE Medial-Pivot Knee (experimental group) versus a more conventional prosthesis (control), the ADVANCE Traditional Knee. Patients (n=60; age 45-80 years old) with primary osteoarthritis of the knee and mono-articular disease will be randomized to receive either the ADVANCE Traditional or ADVANCE Medial-Pivot Knee using Simplex cement. Eight tantalum markers will be placed in both the tibia and femur proximal to the prosthesis and in the polyethylene tray of the tibial component. Pre-operatively and at 6, 12 and 24 months all patients will complete general health (SF-12) and joint specific questionnaires (Oxford -12 Item Knee Score), have their body mass index calculated, and have the range of motion, alignment, extensor function and ligamentous competency of their index knee recorded. On the first weight-bearing day after surgery bi-planar standing x-rays will be taken and used as a reference point for tibial component position. At 6, 12 and 24 months post-operatively patients will undergo more bi-planar standing x-rays incorporating provocative loading tests. Micromotion will be analyzed through serial comparison of digital x-rays by blinded study personnel using RSA software. Parametric statistics (unpaired Student's t-test) will be used to compare the 2 groups.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Advance Medial Pivot Knee Arthroplasty
- Keywords
- arthroplasty, RSA, micromotion, osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advance Medial Pivot Knee ArthroplastyDevice
medial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post. Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post
| Study group | Role | What they receive |
|---|---|---|
| Medial Pivot | Active comparator | Not described Receives: Device: Advance Medial Pivot Knee Arthroplasty |
| Posterior Stabilized | Active comparator | Not described Receives: Device: Advance Medial Pivot Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
tibial implant micromotion relative to tibia at 2 years
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 posted30 Nov 2006 (estimated)
- Study startJul 2001
- Primary completionJun 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalhousie University
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Investigators
- Michael Gross, MD FRCSC PhD, Principal investigator, Dalhousie University & Capital District Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405470
- Sponsor's protocol ID
- DAL06-01
- Status last verified
- Aug 2010
- First submitted
- 28 Nov 2006
- Last updated
- 12 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial Using Roentgen Stereophotogrammetric Analysis of the Advance Medial Pivot Knee
- ClinicalTrials.gov ID
- NCT00405470
- Acronym / sponsor ID
- DAL06-01
- Conditions
- Osteoarthritis, Knee
- Keywords
- arthroplasty, RSA, micromotion, osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Dalhousie UniversityUniversity, hospital or other
- Collaborators
- Stryker Trauma and Extremities
- Study start
- Jul 2001
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 30 Nov 2006 (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 purpose of this study is to determine whether this particular knee replacement is better than those already on the market. By participation, it will further refine the design of future total knee replacements and perhaps increase longevity.
Detailed description
Joint arthroplasty is an effective surgical intervention, however prosthetic survivorship is finite. New or modified prosthetic components are routinely introduced, partly in an effort to improve survivorship. When new technologies emerge for total knee replacement it is not always evident that they are an improvement over existing options. This determination requires long-term follow-up studies. Conventional studies require a large number of patients and approximately 10 years of follow-up. By using RSA to measure micromotion of prostheses over time problems can be elucidated with a much smaller sample over a shorter time period. RSA involves using tantalum markers (0.5-1.0 mm beads inserted in the bone and prosthesis during surgery) to measure motion in subsequent bi-planar x-rays of the joint. The relatively new Medial Pivot Knee (ADVANCE Knee) theoretically reproduces the natural kinematics of the knee but it is unclear what effect this design may have on the forces applied to the tibial component-bone interface. The amount of micromotion of the tibial component is directly related to the amount of force exerted on it and inversely related to its fixation. In this study we propose to compare in vivo micromotion at the tibial component-bone interface with the ADVANCE Medial-Pivot Knee (experimental group) versus a more conventional prosthesis (control), the ADVANCE Traditional Knee. Patients (n=60; age 45-80 years old) with primary osteoarthritis of the knee and mono-articular disease will be randomized to receive either the ADVANCE Traditional or ADVANCE Medial-Pivot Knee using Simplex cement. Eight tantalum markers will be placed in both the tibia and femur proximal to the prosthesis and in the polyethylene tray of the tibial component. Pre-operatively and at 6, 12 and 24 months all patients will complete general health (SF-12) and joint specific questionnaires (Oxford -12 Item Knee Score), have their body mass index calculated, and have the range of motion, alignment, extensor function and ligamentous competency of their index knee recorded. On the first weight-bearing day after surgery bi-planar standing x-rays will be taken and used as a reference point for tibial component position. At 6, 12 and 24 months post-operatively patients will undergo more bi-planar standing x-rays incorporating provocative loading tests. Micromotion will be analyzed through serial comparison of digital x-rays by blinded study personnel using RSA software. Parametric statistics (unpaired Student's t-test) will be used to compare the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial Pivot | Active comparator | Device: Advance Medial Pivot Knee Arthroplasty |
| Posterior Stabilized | Active comparator | Device: Advance Medial Pivot Knee Arthroplasty |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary osteoarthritis of the knee
- Mono-articular disease (Charnley Modified Type A)
Key exclusion criteria (11 listed)
- Significant co-morbidity affecting ability to ambulate
- Flexion contracture greater than 15°
- Tibial subluxation greater than 10 mm on standing AP radiograph
- Greater than 10° of varus or 15° of valgus
- Extension lag greater than 10°
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 |
|---|---|---|
| Advance Medial Pivot Knee Arthroplastymedial pivot total knee arthroplasty tibial component vs standard posterior stabilized tibial component with post. Medial pivot provides a constrained medial condyle through shape of polyethylene and reduces amount of bone removal on femoral side that would otherwise be removed to accommodate PS post | Device | Medial Pivot, Posterior Stabilized |
Primary outcome
tibial implant micromotion relative to tibia at 2 years
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 12 Aug 2010.
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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 Gross, MD FRCSC PhD principal investigator
Dalhousie University & Capital District Health Authority
Questions about this trial
What is this clinical trial studying?
A study testing Advance Medial Pivot Knee Arthroplasty in people with Osteoarthritis, Knee, run by Dalhousie University.
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 2 inclusion and 11 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 12 Aug 2010. 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?
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?
tibial implant micromotion relative to tibia at 2 years (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 12 Aug 2010.