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: December 16, 2013
Last verified: February 2012

May 26, 2010
December 16, 2013
January 2006
January 2012   (final data collection date for primary outcome measure)
Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
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
Knee Society Score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01132378 on ClinicalTrials.gov Archive Site
Quadriceps Strength [ Time Frame: 2 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Osteoarthritis
Procedure: Total knee arthroplasty
staged bilateral total knee arthroplasty (not more than 7 days between surgeries)
Other Name: Stryker Triathlon posterior stabilized components
  • Active Comparator: Mini-midvastus approach
    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.
    Intervention: Procedure: Total knee arthroplasty
  • Active Comparator: Medial Parapatellar Approach
    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.
    Intervention: Procedure: Total knee arthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
21 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01132378
06-01-01
No
R. David Heekin, Heekin Orthopedic Research Institute
Heekin Orthopedic Research Institute
Stryker Orthopaedics
Principal Investigator: R. David Heekin, M.D. Heekin Institute for Orthopedic Research
Heekin Orthopedic Research Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP