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OpenTrials
Completed

NCT Number: NCT01132378

Midvastus Versus 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.

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heekin Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Total knee arthroplasty

Procedure

staged bilateral total knee arthroplasty (not more than 7 days between surgeries)

Other names: Stryker Triathlon posterior stabilized components

Primary outcomes

  1. 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

Secondary outcomes

  1. Quadriceps Strength

    Time frame: 2 year

Sponsors and collaborators

Lead sponsor

Heekin Orthopedic Research Institute

Other

Collaborators

  • Stryker Orthopaedics

Registry information

Official study title

Mini-midvastus vs. Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

Important dates

Study start
2006
Primary completion
2012
Study completion
2012
First posted
May 28, 2010
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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