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Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

This study has been completed.
Sponsor:
Collaborator:
Stryker Orthopaedics
Information provided by (Responsible Party):
R. David Heekin, Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier:
NCT01132378
First received: May 26, 2010
Last updated: February 3, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Osteoarthritis
 Device: Total knee arthroplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Heekin Orthopedic Research Institute:

Primary Outcome Measures:
  • Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quadriceps strength [ Time Frame: 2 year ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mini-midvastus incision Device: Total knee arthroplasty
staged bilateral total knee arthroplasty
Active Comparator: Medial Parapatellar incision Device: Total knee arthroplasty
staged bilateral total knee arthroplasty

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is a male or non-pregnant female between the ages of 21-80.
  2. Patient requires cemented primary total knee replacement.
  3. Patient has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA) or avascular necrosis (AVN).
  4. Patient has intact collateral ligaments.
  5. Patient has signed and dated an IRB approved study specific consent form.
  6. 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.
  7. Patient has failed to respond to conservative treatment modalities.

Exclusion Criteria:

  1. Patient has had a prior procedure of high tibial osteotomy, cruciate ligament reconstruction or patellectomy of the surgical knee.
  2. Patient is morbidly obese, >60% over ideal body weight for frame and height.
  3. Patient has a deformity at the involved knee greater than 45 degrees of flexion, 45 degrees of varus or 45 degrees of valgus.
  4. Patient has an active or suspected latent infection in or about the knee joint.
  5. Patient has a malignancy in the area of the involved knee joint.
  6. 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.
  7. 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.
  8. Female patient is or plans to become pregnant during the course of the study.
  9. Patient has a known sensitivity to device materials.
  10. Patient has prior diagnosis of diabetic or peripheral neuropathy in operative extremity or other neurologic disease affecting limb strength
  11. Patient's bone stock is compromised by disease or infection, which cannot provide adequate support and/or fixation to the prosthesis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132378

Locations
United States, Florida
Heekin Orthopedic Specialists
Jacksonville, Florida, United States, 32204
Sponsors and Collaborators
Heekin Orthopedic Research Institute
Stryker Orthopaedics
Investigators
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
  More Information

No publications provided

Responsible Party: R. David Heekin, R. David Heekin, M.D., Heekin Orthopedic Research Institute
ClinicalTrials.gov Identifier: NCT01132378     History of Changes
Other Study ID Numbers: 06-01-01
Study First Received: May 26, 2010
Last Updated: February 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Heekin Orthopedic Research Institute:
Total knee arthroplasty

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on May 21, 2013