Knee OsteoarthritisNCT00983762
Comparison of Functional Outcomes of Three Surgical Approaches in Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Massachusetts General Hospital.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- TKA subjects:
- Patients requiring primary knee arthroplasty;
- Knee osteoarthritis;
- Subject has sufficient quantity or quality of bone support;
- Subject has no previous or active infection in the affected joint or systemic infection;
- Subject judged to be available for follow-up through at least 1 year postoperative;
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- All subjects in arthroplasty groups will be between 50-70 years of age
- Healthy subjects:
- Healthy subjects will have no complaints of knee pain or history of knee surgery or known arthritic knee changes.
- All subjects will have no history of prior lower extremity arthroplasty surgeries or systemic disease which could confound outcome measures.
- All healthy persons will be 40-70 years.
Who cannot join
- Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
- Unable to return for follow up x-rays and clinical evaluation;
- Unable to comprehending study protocol for any reason;
- Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
- 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;
- Subject has a neurologic condition that would influence the results of biomechanical analysis of whole body movement.
About this study
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
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.
Read the 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.
- 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
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isokinetic and isometric quadriceps and hamstring strength
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Secondary outcomes (9)
American Academy Orthopaedic Surgeons Knee Score
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
University California Los Angeles Activity Score
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Western Ontario McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Timed "Up & Go" Test
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Sit to Stand to Sit (STSTS) Test
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Stair Test
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Visual Analog Pain Scale
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee adductor moment during gait and chair rise
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Knee loading pattern during gait & chair rise
Measured: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionJan 2020 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: No continued funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Investigators
- Henrik Malchau, PhD, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00983762
- Sponsor's protocol ID
- 2007P001220
- Status last verified
- Nov 2009
- First submitted
- 23 Sep 2009
- Last updated
- 5 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00983762
- Acronym / sponsor ID
- 2007P001220
- 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
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No continued funding.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- Jun 2009
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 24 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- TKA subjects:
- Healthy subjects:
Key exclusion criteria (6 listed)
- Insufficient quantity or quality of bone support resulting from conditions such as cancer, femoral osteotomy, significant osteoporosis or metabolic disorders of calcified tissues;
- Unable to return for follow up x-rays and clinical evaluation;
- Unable to comprehending study protocol for any reason;
- Systemic inflammatory joint disease (rheumatoid arthritis), previous infection or those requiring revision knee surgery;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
9 secondary outcomes
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
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
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
Timed "Up & Go" Test
Time frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
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
Stair Test
Time frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
Visual Analog Pain Scale
Time frame: Pre-op, post op: 4 weeks, 3 months, 6 months and at 1, 2, 5, 10 years
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
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
Results and safety
The study was stopped early (reason given: No continued funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Malchau, PhD, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No continued funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2009.