OsteoarthritisNCT01132378
Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
A study testing Total knee arthroplasty 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 compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. 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 arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 the expected term of follow-up, and to follow their physician's directions.
- Patient has failed to respond to conservative treatment modalities.
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, >60% over ideal body weight for frame and height.
- Patient has a deformity at the involved knee greater than 45 degrees 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 systemic disease that would affect the subject's welfare or overall outcome of the study (i.e. moderate to severe osteoporosis, Paget's disease) 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 the 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
- Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Heekin Orthopedic Specialists
Jacksonville, Florida, 32204
About this study
Official title: Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
The purpose of this study is to compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.
- Conditions
- Osteoarthritis
- Being tested
- Total knee arthroplasty
- 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 knee arthroplastyProcedure or surgery
Also called Stryker Triathlon posterior stabilized components
staged bilateral total knee arthroplasty (not more than 7 days between surgeries)
| Study group | Role | What they receive |
|---|---|---|
| Mini-midvastus approach | Active comparator | Mini Midvastus approach with skin incision less than 13 cm long and vastus medialis obliquus dissection not more than 3 cm from the patellar margin was used to perform total knee arthroplasty in 40 patients. Receives: Procedure: Total knee arthroplasty |
| Medial Parapatellar Approach | Active comparator | Mini Medial Parapatellar approach with skin incision less than 13 cm. The extension into quadriceps tendon did not exceed 3 cm.Mini medial parapatellar approach was used to perform total knee arthroplasty. Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Society Score
The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain
Measured: 2 year
Secondary outcomes (1)
Quadriceps Strength
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2010 (estimated)
- Study startJan 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.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 40 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
- Investigators
- R. David Heekin, M.D., Principal investigator, Heekin Institute for Orthopedic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01132378
- Sponsor's protocol ID
- 06-01-01
- Status last verified
- Feb 2012
- First submitted
- 26 May 2010
- Last updated
- 17 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01132378
- Acronym / sponsor ID
- 06-01-01
- Conditions
- Osteoarthritis
- Keywords
- Total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Heekin Orthopedic Research InstituteUniversity, hospital or other
- Collaborators
- Stryker Orthopaedics
- Study start
- Jan 2006
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 28 May 2010 (estimated)
- Results
- Posted 19 Nov 2013
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 compare two different surgical approaches for total knee replacement surgery. The mini-midvastus approach involves cutting less of the thigh muscle (quadriceps) tendon than the classic approach (median parapatellar) in order to implant the knee components. Both will have the same skin incision.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-midvastus approach | Active comparator | Procedure: Total knee arthroplastyMini Midvastus approach with skin incision less than 13 cm long and vastus medialis obliquus dissection not more than 3 cm from the patellar margin was used to perform total knee arthroplasty in 40 patients. |
| Medial Parapatellar Approach | Active comparator | Procedure: Total knee arthroplastyMini Medial Parapatellar approach with skin incision less than 13 cm. The extension into quadriceps tendon did not exceed 3 cm.Mini medial parapatellar approach was used to perform total knee arthroplasty. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 (11 listed)
- Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
- Patient is morbidly obese, >60% over ideal body weight for frame and height.
- Patient has a deformity at the involved knee greater than 45 degrees 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 knee arthroplastyAlso: Stryker Triathlon posterior stabilized componentsstaged bilateral total knee arthroplasty (not more than 7 days between surgeries) | Procedure or surgery | Medial Parapatellar Approach, Mini-midvastus approach |
Primary outcome
Knee Society Score
Time frame: 2 year
The higher the score the better is the result (0-100). The knee society score reflects the outcomes and perception of the patients regarding function and pain
1 secondary outcome
Quadriceps Strength
Time frame: 2 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
R. David Heekin, M.D. principal investigator
Heekin Institute for Orthopedic Research
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 arthroplasty 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 7 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 17 Jan 2014. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knee Society Score (time frame: 2 year). 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 17 Jan 2014.