OsteoarthritisAR vs PRNCT01135030
Anterior Referencing Versus Posterior Referencing in Minimally Invasive Total Knee Arthroplasty
A study testing Total knee in people with Osteoarthritis, run by Heekin Orthopedic Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to look at two different referencing systems for total knee replacement surgery. In anterior referencing system, referencing cuts are made from the front surface of the femur. This allows for a more exact cut. The anterior referencing system is more difficult for the surgeon to use. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total knee
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jan 2012
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is a male or non-pregnant female between the ages of 21-80.
- Patient requires cemented primary total knee replacement.
- Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patient has intact collateral ligaments.
- Patient has signed and dated an IRB approved study specific consent form.
- Patient is able and willing to participate in the study according to the protocol for the full length of expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
- Patient's contralateral knee is without symptomatic degenerative disease.
Who cannot join
- Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
- Patient is morbidly obese (BMI >30).
- Patient has a deformity at the involved knee greater than 45degrees of flexion, 45 degrees of varus or 45 degrees of valgus.
- Patient has an active or suspected latent infection in or about the knee joint.
- Patient has a malignancy in the area of the involved knee joint.
- Patient has a diagnosed systematic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease, renal osteodystrophy) or is immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
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- Patient has a neurological deficit, which interferes with the patient's ability to limit weight bearing or places an extreme load on implant during the healing period.
- Female patient is or plans to become pregnant during the course of the study.
- Patient has a known sensitivity to device materials.
- Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength (i.e. Polymyositis, multiple sclerosis).
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
- Patient has a TKA on the contralateral side less than six months post-op.
- Patient has participated in an orthopaedic clinical investigation involving the hip or knee joint in the last 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heekin Orthopedic Specialists
Jacksonville, Florida, 32204
About this study
Official title: Anterior Referencing Vs. Posterior Referencing in Minimally Invasive Total Knee Arthroplasty
The purpose of this study is to look at two different referencing systems for total knee replacement surgery. In anterior referencing system, referencing cuts are made from the front surface of the femur. This allows for a more exact cut. The anterior referencing system is more difficult for the surgeon to use. This may increase surgery time. Posterior referencing, on the other hand, references cuts from the back of the femur. The posterior referencing system is quick and easy for the surgeon to use. Posterior referencing may lead to notching of the femur. The risk of notching is very low and may not affect your results. This is a study that has never been done before. Dr. Heekin uses both referencing systems in his practice. He would like to determine which knee referencing system allows for greater knee flexion after surgery. Knee flexion correlates with function and the ability to return to everyday activities. For example, getting up from a chair, going up and down stairs, stooping, and kneeling.
- Conditions
- Osteoarthritis
- Being tested
- Total knee
- Keywords
- total knee arthroplasty
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total kneeProcedure or surgery
Primary Total knee
| Study group | Role | What they receive |
|---|---|---|
| Posterior referencing | Active comparator | Not described Receives: Procedure: Total knee |
| Anterior referencing | Active comparator | Not described Receives: Procedure: Total knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
greater flexion after surgery
Measured: 12 months
Secondary outcomes (1)
greater flexion after surgery
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startOct 2006
- Primary completionJan 2012
- Study completionJan 2012
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heekin Orthopedic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Orthopaedics
- Responsible party
- Principal investigator, R. David Heekin, Heekin Orthopedic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135030
- Sponsor's protocol ID
- 06-09-03
- Acronym
- AR vs PR
- Status last verified
- Feb 2012
- First submitted
- 26 May 2010
- Last updated
- 6 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Referencing Vs. Posterior Referencing in Minimally Invasive Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01135030
- Acronym / sponsor ID
- AR vs PR / 06-09-03
- Conditions
- Osteoarthritis
- Keywords
- total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Heekin Orthopedic Research InstituteUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Oct 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Jun 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.
The purpose of this study is to look at two different referencing systems for total knee replacement surgery. In anterior referencing system, referencing cuts are made from the front surface of the femur. This allows for a more exact cut. The anterior referencing system is more difficult for the surgeon to use. This may increase surgery time. Posterior referencing, on the other hand, references cuts from the back of the femur. The posterior referencing system is quick and easy for the surgeon to use. Posterior referencing may lead to notching of the femur. The risk of notching is very low and may not affect your results. This is a study that has never been done before. Dr. Heekin uses both referencing systems in his practice. He would like to determine which knee referencing system allows for greater knee flexion after surgery. Knee flexion correlates with function and the ability to return to everyday activities. For example, getting up from a chair, going up and down stairs, stooping, and kneeling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Posterior referencing | Active comparator | Procedure: Total knee |
| Anterior referencing | Active comparator | Procedure: Total knee |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient is a male or non-pregnant female between the ages of 21-80.
- Patient requires cemented primary total knee replacement.
- Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
- Patient has intact collateral ligaments.
- Patient has signed and dated an IRB approved study specific consent form.
Key exclusion criteria (13 listed)
- Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
- Patient is morbidly obese (BMI >30).
- Patient has a deformity at the involved knee greater than 45degrees of flexion, 45 degrees of varus or 45 degrees of valgus.
- Patient has an active or suspected latent infection in or about the knee joint.
- Patient has a malignancy in the area of the involved knee joint.
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 kneePrimary Total knee | Procedure or surgery | Anterior referencing, Posterior referencing |
Primary outcome
greater flexion after surgery
Time frame: 12 months
1 secondary outcome
greater flexion after surgery
Time frame: 24 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 6 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee in people with Osteoarthritis, run by Heekin Orthopedic Research Institute at 1 site in United States.
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 8 inclusion and 13 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 6 Feb 2012. 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 United States. 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?
greater flexion after surgery (time frame: 12 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 6 Feb 2012.