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N/A N=40 Randomized Single-blind Treatment

Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Osteoarthritis

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Knee Society Score — 98.70; 99.03 score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Total knee arthroplasty (Procedure)
Age
Adult, Older Adult · 21+ yrs
Sex
All
Sponsor
Heekin Orthopedic Research Institute
Primary completion
Jan 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Knee Society Score
98.70; 99.03
SECONDARY
Quadriceps Strength

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01132378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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