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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Total knee arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Heekin Orthopedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Procedure: Total knee arthroplasty; staged bilateral total knee arthroplasty (not more than 7 days between surgeries); Other Names: Stryker Triathlon posterior stabilized components
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.	Procedure: Total knee arthroplasty; staged bilateral total knee arthroplasty (not more than 7 days between surgeries); Other Names: Stryker Triathlon posterior stabilized components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee Society Score	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	2 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Quadriceps Strength	2 year

Collaborators and Investigators

• Sponsor: Heekin Orthopedic Research Institute
• Collaborators: Stryker Orthopaedics

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: May 27, 2010
• First Posted (Estimate): May 28, 2010

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: December 16, 2013
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: Total knee arthroplasty
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: 06-01-01