Midvastus Versus Medial Parapatellar Approach for Minimally Invasive Total Knee Arthroplasty

NCT01132378 | Completed Results

• 1 other identifier: 06-01-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

Total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quadriceps Strength

  2 year

Study Arms (2)

Mini-midvastus approach

ACTIVE COMPARATOR

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

Medial Parapatellar Approach

ACTIVE COMPARATOR

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

Interventions

Total knee arthroplasty PROCEDURE

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

Also known as: Stryker Triathlon posterior stabilized components

Medial Parapatellar Approach; Mini-midvastus approach

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heekin Orthopedic Research Institute: lead
• Stryker Orthopaedics: collaborator

Study Sites (1)

Heekin Orthopedic Specialists

Jacksonville, Florida, 32204, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Limitations and Caveats

The strength of the study is the standardized surgical protocol performed by a single surgeon and a prospectively randomized consecutive and blinded subjects

Results Point of Contact

• Title: R. David Heekin MD, FACS
• Organization: Heekin Institute for Orthopaedic Research

drheekin@heekinortho.com

904-634-0640

Study Officials

• R. David Heekin, M.D.

  Heekin Institute for Orthopedic Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: R. David Heekin, M.D.

Study Record Dates

• First Submitted: May 26, 2010
• First Posted: May 28, 2010
• Study Start: January 1, 2006
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: January 17, 2014
• Results First Posted: November 19, 2013

Record last verified: 2012-02

Locations

US (1)