OsteoarthritisPhase 2NCT00710840
Effectiveness of Minimally Invasive Total Knee Replacement in Improving Rehabilitation and Function
A Phase 2 study testing Minimally Invasive Total Knee Arthroplasty [TKA Min] and Total Knee Arthroplasty (TKA) Traditional in people with Osteoarthritis, run by University of Colorado, Denver at 3 sites in United States.
Trial summary
Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Minimally Invasive Total Knee Arthroplasty [TKA Min] and Total Knee Arthroplasty (TKA) Traditional
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2008to Jan 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Who cannot join
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Health Sciences Center
Boulder, Colorado, 80304
National Jewish Medical and Research Center
Denver, Colorado, 80206
University of Colorado Health Sciences Center
Denver, Colorado, 80262
About this study
Official title: Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.
Read the detailed description
More than 400,000 TKAs are performed each year in the United States to alleviate pain and disability associated with knee OA. Although this procedure reliably reduces pain and improves function in people with knee OA, recovery of the strength of the quadriceps muscle to normal levels is rare. For years after a TKA, performance while walking or while doing a more physically demanding activity, such as stair climbing, is also significantly lower in people who have had a TKA than in healthy adults of the same age. Within the past few years, less invasive TKA surgical techniques have been developed as promising alternatives to traditional TKA. Minimally invasive TKA, or TKA(min), achieves the same surgical objectives, but possibly without doing as much damage to the quadriceps muscle as is seen with traditional TKA. No studies, however, have specifically investigated how TKA(min) might preserve quadriceps muscle function. This study will determine whether TKA(min) is better than TKA at improving quadriceps muscle force production and activation, increasing knee range of motion, and reducing post-operative pain to improve overall functional outcomes.
Participants who are scheduled to undergo knee replacement surgery will be randomly assigned to receive either traditional TKA or TKA(min). Prior to surgery, participants will attend a 30-minute orientation session and undergo certain tests to evaluate knee function. Functional testing will include timed walking, stair climbing, balance testing, and knee flexibility measurements. Other evaluations will include thigh muscle strength and activation testing, which uses brief electrical pulses to determine if the muscles are contracted as much as possible, and health status questionnaires. After the operation, participants will be instructed to use walking aids, such as a walker, crutches, or a cane, for a period of time. Participants will attend study visits for repeat testing 48 hours following surgery; at Months 1, 3, and 6; and at Years 1 and 2.
- Conditions
- Osteoarthritis
- Being tested
- Minimally Invasive Total Knee Arthroplasty [TKA Min], Total Knee Arthroplasty (TKA) Traditional
- Keywords
- Knee Replacement, Knee OA, OA
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally Invasive Total Knee Arthroplasty [TKA Min]Procedure or surgery
Also called TKA Min
TKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery.
Total Knee Arthroplasty (TKA) TraditionalProcedure or surgery
Also called TKA Traditional
TKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Procedure: Minimally Invasive Total Knee Arthroplasty [TKA Min] |
| 2 | Active comparator | Not described Receives: Procedure: Total Knee Arthroplasty (TKA) Traditional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quadriceps Muscle Force
Measured: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Range of Motion
Knee Flexion Active Range of Motion (AROM)
Measured: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Secondary outcomes (2)
Functional Performance: 6 Minute Walk (6MW) Distance
Measured: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test
This outcome measures the time (seconds) it takes to climb up and back down 12 steps.
Measured: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Jennifer E. Stevens, MPT, PhD, Principal investigator, University of Colorado, DenverMichael Dayton, MD, Principal investigator, University of Colorado, DenverWendy Kohrt, PhD, Principal investigator, University of Colorado School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00710840
- Sponsor's protocol ID
- 06-0183
- Other IDs
- R03AR054538, 1R03AR054538-01A2
- Status last verified
- Mar 2015
- First submitted
- 27 Jun 2008
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Outcomes Following Minimally Invasive Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00710840
- Acronym / sponsor ID
- 06-0183
- Conditions
- Osteoarthritis
- Keywords
- Knee Replacement, Knee OA, OA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Jun 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Jul 2008 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osteoarthritis (OA) is a long-term degenerative joint disease that disables about 10% of people over the age of 60 and compromises the quality of life of more than 20 million Americans. A procedure called total knee arthroplasty (TKA), in which the affected surface of the knee joint is replaced by plastic or metal, has been successful in restoring comfort and mobility to formerly arthritic joints. This study will compare quadriceps muscle strength, knee range of motion, and pain in people who have had a traditional TKA with those who have had a minimally invasive TKA.
Detailed description
More than 400,000 TKAs are performed each year in the United States to alleviate pain and disability associated with knee OA. Although this procedure reliably reduces pain and improves function in people with knee OA, recovery of the strength of the quadriceps muscle to normal levels is rare. For years after a TKA, performance while walking or while doing a more physically demanding activity, such as stair climbing, is also significantly lower in people who have had a TKA than in healthy adults of the same age. Within the past few years, less invasive TKA surgical techniques have been developed as promising alternatives to traditional TKA. Minimally invasive TKA, or TKA(min), achieves the same surgical objectives, but possibly without doing as much damage to the quadriceps muscle as is seen with traditional TKA. No studies, however, have specifically investigated how TKA(min) might preserve quadriceps muscle function. This study will determine whether TKA(min) is better than TKA at improving quadriceps muscle force production and activation, increasing knee range of motion, and reducing post-operative pain to improve overall functional outcomes.
Participants who are scheduled to undergo knee replacement surgery will be randomly assigned to receive either traditional TKA or TKA(min). Prior to surgery, participants will attend a 30-minute orientation session and undergo certain tests to evaluate knee function. Functional testing will include timed walking, stair climbing, balance testing, and knee flexibility measurements. Other evaluations will include thigh muscle strength and activation testing, which uses brief electrical pulses to determine if the muscles are contracted as much as possible, and health status questionnaires. After the operation, participants will be instructed to use walking aids, such as a walker, crutches, or a cane, for a period of time. Participants will attend study visits for repeat testing 48 hours following surgery; at Months 1, 3, and 6; and at Years 1 and 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Minimally Invasive Total Knee Arthroplasty [TKA Min] |
| 2 | Active comparator | Procedure: Total Knee Arthroplasty (TKA) Traditional |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of osteoarthritis
- Eligible for a unilateral or bilateral primary TKA to be performed by Dr. Michael Dayton (University of Colorado Hospital)
- Minimum of 110 degrees of active knee flexion
- No greater than 10 degrees of anatomic knee varus, 15 degrees anatomic valgus, and 10 degrees flexion contracture
- Body mass index less ≤ 40 kg/m2
Key exclusion criteria (2 listed)
- Any brain, circulation, or heart problems that limit function
- Severe osteoarthritis or other orthopedic conditions that limit function in the lower extremity that is not undergoing the TKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally Invasive Total Knee Arthroplasty [TKA Min]Also: TKA MinTKA Min is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. TKA Min, as opposed to TKA Traditional, employs smaller skin incisions and smaller instrumentation and avoids turning the knee cap out and dislocating the knee. This procedure also avoids disrupting the knee extensor mechanism and the suprapatellar pouch and minimizes extreme knee flexion during surgery. | Procedure or surgery | 1 |
| Total Knee Arthroplasty (TKA) TraditionalAlso: TKA TraditionalTKA is a procedure in which diseased and painful joint surfaces of the knee are replaced by metal and plastic components shaped to allow continued motion of the knee. | Procedure or surgery | 2 |
Primary outcome
Quadriceps Muscle Force
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Range of Motion
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Knee Flexion Active Range of Motion (AROM)
2 secondary outcomes
Functional Performance: 6 Minute Walk (6MW) Distance
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Functional Performance: Stair Climb Test
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Jennifer E. Stevens, MPT, PhD principal investigator
University of Colorado, Denver
Michael Dayton, MD principal investigator
University of Colorado, Denver
Wendy Kohrt, PhD principal investigator
University of Colorado School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Minimally Invasive Total Knee Arthroplasty [TKA Min] and Total Knee Arthroplasty (TKA) Traditional in people with Osteoarthritis, run by University of Colorado, Denver at 3 sites in United States.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quadriceps Muscle Force (time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks). The study lists 2 primary outcomes in all. 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 10 Jun 2015.