Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty: The Minimally Invasive Surgery Mini-Incision (MIS) TKA, Standard Para-Patellar Surgery TKA and the Unicompartmental Knee Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00983762
• Other study ID #: 2007P001220
• Status: Terminated
• Phase: N/A
• First received: September 23, 2009
• Last updated: November 4, 2009
• Start date: June 2009
• Est. completion date: January 2020

Study information

• Verified date: November 2009
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

A functional outcomes comparison study of three surgical techniques using minimally invasive surgery mini-incision (MIS) for total knee arthroplasty (TKA), standard para-patellar TKA and the unicompartmental knee arthroplasty performed over a 2+ year post-op period.

Description:

The purpose of this research study is to compare post-operative knee function of persons who have undergone one of three types of knee arthroplasty for the treatment of knee osteoarthritis. A variety of functional performance tests will be assessed and compared using a group of evaluations including: functional activity performance tests and questionnaires; leg strength; knee range of motion; and forces at the knee during a series of activities (walking, bending, stepping etc.) via a motion analysis system. The study will compare the three surgical subject groups and one group of healthy, non-surgical subjects for a total of 100 subjects.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• TKA subjects:

1. Patients requiring primary knee arthroplasty;

2. Knee osteoarthritis;

3. Subject has sufficient quantity or quality of bone support;

4. Subject has no previous or active infection in the affected joint or systemic infection;

5. Subject judged to be available for follow-up through at least 1 year postoperative;

6. All subjects in arthroplasty groups will be between 50-70 years of age

• Healthy subjects:

1. Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.

2. All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.

3. All healthy persons will be 40-70 years.

Exclusion Criteria:

1. Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;

2. Unable to return for follow up x-rays and clinical evaluation;

3. Unable to comprehending study protocol for any reason;

4. Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;

5. Subject has an immunological disorder: immunosuppressive treatment characterized by markedly inhibited ability to respond to antigenic stimuli. Examples of such conditions include Subjects who are on immunosuppressive therapy (corticosteroid hormones in large amounts, cytotoxic drugs, antilymphocytic serum or irradiation in large doses), Subjects receiving therapy to prevent homograft rejection, Subjects who have a documented history of acquired immunodeficiency syndrome (AIDS), or auto-immune diseases;

6. Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Zimmer, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isokinetic and isometric quadriceps and hamstring strength		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	American Academy Orthopaedic Surgeons Knee Score		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	University California Los Angeles Activity Score		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Timed "Up & Go" Test		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Sit to Stand to Sit (STSTS) Test		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Stair Test		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Visual Analog Pain Scale		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Knee adductor moment during gait and chair rise		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No
Secondary	Knee loading pattern during gait & chair rise		Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years	No