Osteoarthritis
Conditions
Keywords
Knee Replacement, Knee OA, OA
Brief 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. 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.
Interventions
PROCEDUREMinimally Invasive Total Knee Arthroplasty [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.
PROCEDURETotal Knee Arthroplasty (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.
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quadriceps Muscle Force | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks | — |
| Knee Range of Motion | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks | Knee Flexion Active Range of Motion (AROM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Performance: 6 Minute Walk (6MW) Distance | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks | — |
| Functional Performance: Stair Climb Test | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks | This outcome measures the time (seconds) it takes to climb up and back down 12 steps. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TKA Min Minimally Invasive Total Knee Arthroplasty \[TKA(min)\]: 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, 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. | 22 |
| TKA Traditional Total Knee Arthroplasty (TKA): 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. | 22 |
| Total | 44 |
Baseline characteristics
| Characteristic | TKA Min | TKA Traditional | Total |
|---|---|---|---|
| Age, Continuous | 64.6 years STANDARD_DEVIATION 8.5 | 64.0 years STANDARD_DEVIATION 8.4 | 64.3 years STANDARD_DEVIATION 8.4 |
| BMI | 30.5 kg\m^2 STANDARD_DEVIATION 5.6 | 31.3 kg\m^2 STANDARD_DEVIATION 5.1 | 30.9 kg\m^2 STANDARD_DEVIATION 5.4 |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 22 | 22 / 22 |
| serious Total, serious adverse events | 1 / 22 | 0 / 22 |
Outcome results
Primary
Knee Range of Motion
Knee Flexion Active Range of Motion (AROM)
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TKA Min | Knee Range of Motion | Flexion AROM Preop | 120.0 degrees | Standard Deviation 16.7 |
| TKA Min | Knee Range of Motion | Flexion AROM 4 weeks Postop | 98.6 degrees | Standard Deviation 12.3 |
| TKA Min | Knee Range of Motion | Flexion AROM 12 weeks Postop | 113.5 degrees | Standard Deviation 10.6 |
| TKA Traditional | Knee Range of Motion | Flexion AROM Preop | 119.3 degrees | Standard Deviation 15.8 |
| TKA Traditional | Knee Range of Motion | Flexion AROM 4 weeks Postop | 96.9 degrees | Standard Deviation 13.9 |
| TKA Traditional | Knee Range of Motion | Flexion AROM 12 weeks Postop | 112.4 degrees | Standard Deviation 9.4 |
p-value: 0.48t-test, 2 sided
Primary
Quadriceps Muscle Force
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TKA Min | Quadriceps Muscle Force | Quadriceps Strength Preop | 1.27 Nm/kg | Standard Deviation 0.56 |
| TKA Min | Quadriceps Muscle Force | Quadriceps Strength 4 weeks Postop | 0.79 Nm/kg | Standard Deviation 0.39 |
| TKA Min | Quadriceps Muscle Force | Quadriceps Strength 12 weeks Postop | 1.24 Nm/kg | Standard Deviation 0.4 |
| TKA Traditional | Quadriceps Muscle Force | Quadriceps Strength Preop | 1.37 Nm/kg | Standard Deviation 0.56 |
| TKA Traditional | Quadriceps Muscle Force | Quadriceps Strength 4 weeks Postop | 0.66 Nm/kg | Standard Deviation 0.23 |
| TKA Traditional | Quadriceps Muscle Force | Quadriceps Strength 12 weeks Postop | 1.20 Nm/kg | Standard Deviation 0.42 |
Comparison: The primary outcome, difference in quadriceps torque between intervention (TKA Min) and Control TKA at 4 weeks, was tested using an analysis of covariance model. Confirmatory measures were evaluated at 4 and 12 weeks after surgery in the same way. Baseline characteristics of the treatment groups were compared using 2-sample t tests for continuous measures or a χ2 test for independent proportions for categorical measures. A 2-sided α level of .05 was designated for statistical significance.p-value: 0.07t-test, 2 sided
Secondary
Functional Performance: 6 Minute Walk (6MW) Distance
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TKA Min | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW Preop | 464.0 Meters | Standard Deviation 124.9 |
| TKA Min | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW 4 weeks Postop | 345.9 Meters | Standard Deviation 111.2 |
| TKA Min | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW 12 weeks Postop | 474.6 Meters | Standard Deviation 105.4 |
| TKA Traditional | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW Preop | 434.7 Meters | Standard Deviation 147.8 |
| TKA Traditional | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW 4 weeks Postop | 326.6 Meters | Standard Deviation 125.7 |
| TKA Traditional | Functional Performance: 6 Minute Walk (6MW) Distance | 6MW 12 weeks Postop | 448.5 Meters | Standard Deviation 124.8 |
p-value: 0.92t-test, 2 sided
Secondary
Functional Performance: Stair Climb Test
This outcome measures the time (seconds) it takes to climb up and back down 12 steps.
Time frame: Measured pre-operatively; post-surgery at 4 weeks and 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TKA Min | Functional Performance: Stair Climb Test | Stair Climb Preop | 18.1 Seconds | Standard Deviation 9.7 |
| TKA Min | Functional Performance: Stair Climb Test | Stair Climb 4 weeks Postop | 35.0 Seconds | Standard Deviation 18.7 |
| TKA Min | Functional Performance: Stair Climb Test | Stair Climb 12 weeks Postop | 15.9 Seconds | Standard Deviation 8.7 |
| TKA Traditional | Functional Performance: Stair Climb Test | Stair Climb Preop | 19.4 Seconds | Standard Deviation 17.2 |
| TKA Traditional | Functional Performance: Stair Climb Test | Stair Climb 4 weeks Postop | 32.2 Seconds | Standard Deviation 17.3 |
| TKA Traditional | Functional Performance: Stair Climb Test | Stair Climb 12 weeks Postop | 16.4 Seconds | Standard Deviation 7.8 |
p-value: 0.41t-test, 2 sided