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Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT00983762
Recruitment Status : Terminated (No continued funding.)
First Posted : September 24, 2009
Last Update Posted : November 5, 2009
Sponsor:
Collaborator:
Zimmer Biomet
Information provided by:
Massachusetts General Hospital

Brief 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.

Condition or disease
Knee Osteoarthritis

Detailed 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.

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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Study Start Date : June 2009
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort
MIS knee arthroplasty
Persons scheduled for Minimally Invasive Surgery Mini-Incision (MIS) Total Knee Arthroplasty (TKA)
Unicompartmental knee arthroplasty
Persons scheduled for Unicompartmental knee arthroplasty
Standard knee arthroplasty
Persons scheduled for Standard Para-patellar surgery TKA
Heathly knee subjects
Persons with healthy knees



Primary Outcome Measures :
  1. Isokinetic and isometric quadriceps and hamstring strength [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]

Secondary Outcome Measures :
  1. American Academy Orthopaedic Surgeons Knee Score [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  2. University California Los Angeles Activity Score [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  3. Western Ontario McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  4. Timed "Up & Go" Test [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  5. Sit to Stand to Sit (STSTS) Test [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  6. Stair Test [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  7. Visual Analog Pain Scale [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  8. Knee adductor moment during gait and chair rise [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]
  9. Knee loading pattern during gait & chair rise [ Time Frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

TKA subjects:

Subjects will be selected and recruited from the MGH Arthroplasty Clinic. The surgical decision for TKA approach will be made prior to recruitment for the study.

Healthy persons:

Healthy subjects will be recruited through orthopedic departmental advertisement flyers and by word of mouth.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983762


Sponsors and Collaborators
Massachusetts General Hospital
Zimmer Biomet
Investigators
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Principal Investigator: Henrik Malchau, PhD, MD Massachusetts General Hospital
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Responsible Party: Henrik Malchau, PhD, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00983762    
Other Study ID Numbers: 2007P001220
First Posted: September 24, 2009    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009
Keywords provided by Massachusetts General Hospital:
Knee osteoarthritis
Leg strength
Functional outcomes
Minimally Invasive Surgery Mini-Incision (MIS) TKA
Unicompartmental knee arthroplasty
Standard Para-patellar surgery TKA
gait
knee arthroplasty
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases