Clinical trial NCT00983762: Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Leg strength
Functional outcomes
Minimally Invasive Surgery Mini-Incision (MIS) TKA
Unicompartmental knee arthroplasty
Standard Para-patellar surgery TKA
gait
knee arthroplasty
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Zimmer Biomet
First posted: 2009-09-24
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Isokinetic and isometric quadriceps and hamstring strength
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Secondary outcomes:
measure: American Academy Orthopaedic Surgeons Knee Score
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: University California Los Angeles Activity Score
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Timed "Up & Go" Test
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Sit to Stand to Sit (STSTS) Test
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Stair Test
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Visual Analog Pain Scale
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Knee adductor moment during gait and chair rise
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
measure: Knee loading pattern during gait & chair rise
timeFrame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts General Hospital
name: Henrik Malchau, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: