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Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Not Applicable
Completed
Conditions
Osteoarthritis
Interventions
Procedure: Total knee arthroplasty
Registration Number
NCT01132378
Lead Sponsor
Heekin Orthopedic Research Institute
Brief 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. Both will have the same skin incision.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Mini-midvastus approachTotal 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 ApproachTotal 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.
Primary Outcome Measures
NameTimeMethod
Knee Society Score2 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

Secondary Outcome Measures
NameTimeMethod
Quadriceps Strength2 year

Trial Locations

Locations (1)

Heekin Orthopedic Specialists

🇺🇸

Jacksonville, Florida, United States

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