Minimally Invasive Surgical Approaches In Total Knee Arthroplasty

NCT01461356 | Completed

• 1 other identifier: 07-001613
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of the proposed study is that performing total knee arthroplasty through a mini subvastus approach results in statistically significant differences in one or more of the above functional outcome measures, when compared in a blinded, prospective, controlled, randomized manner to mini-medial arthrotomy approach.

1. 1.Analyses of lower extremity functional activities (gait and stairs)
2. 2.Strength of thigh musculature
3. 3.Self-assessment of the functional outcomes
4. 4.Return to the activities of daily living and sports activities

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Knee Society Clinical Rating Score

  The two patient cohorts, minimally invasive surgical approach and standard medial parapatellar approach, will be followed prospectively and evaluated with the Knee Society Clinical Rating Score.

  2 months

Secondary Outcomes (1)

• Comprehensive gait analysis

  2 months

Study Arms (2)

Minimally Invasive Surgical approach

EXPERIMENTAL

Minimally invasive surgical approach for total knee replacement.

Procedure: Minimally invasive total knee replacement

Medial Parapatellar surgical approach

ACTIVE COMPARATOR

Standard medial parapateller surgical approach for total knee replacement.

Procedure: Standard approach total knee replacement

Interventions

Minimally invasive total knee replacement PROCEDURE

A cemented tricompartmental total knee replacement will be performed using a minimally invasive surgical approach.

Also known as: Posterior stabilzed total knee replacement., Minimally invasive total knee replacement.

Minimally Invasive Surgical approach

Standard approach total knee replacement PROCEDURE

A cemented tricompartmental total knee replacement will be performed using a traditional medial parapatellar surgical approach.

Also known as: Posterior stabilized total knee replacement., Minimally invasive total knee replacment.

Medial Parapatellar surgical approach

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary arthroplasty
• Age between 45 and 75 years old
• Single condylar implant design

You may not qualify if:

• Revision arthroplasty
• Age less than 45 and greater than 75 years old
• Pre-operative flexion lower than 90 degrees
• Valgus or varus knee deformity greater than 15 degrees.
• The presence of infections, highly communicable diseases (AIDS, active tuberculosis, venereal disease, hepatitis) or metastasis disease.
• Significant neurological or musculoskeletal disorders or disease that may interfere with normal gait or weight bearing.
• Any congenital, developmental, or other bone disease or previous hip surgery that may, in the surgeon's judgment, interfere with TK prosthesis survival or success.
• Presence of previous prosthetic knee or hip replacement device.
• BMI \> 30.
• Pregnant women.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Mark W Pagnano, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2011
• First Posted: October 28, 2011
• Study Start: March 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 28, 2011

Record last verified: 2011-10

Locations

US (1)