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| ID | Type | Description | Link |
|---|---|---|---|
| R03AR054538 | U.S. NIH Grant/Contract | View source | |
| 1R03AR054538-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Total Knee Arthroplasty [TKA Min] | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Quadriceps Muscle Force | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks | |
| Knee Range of Motion | Knee Flexion Active Range of Motion (AROM) | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional Performance: 6 Minute Walk (6MW) Distance | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer E. Stevens, MPT, PhD | University of Colorado, Denver | Principal Investigator |
| Michael Dayton, MD | University of Colorado, Denver | Principal Investigator |
| Wendy Kohrt, PhD | University of Colorado School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Health Sciences Center | Boulder | Colorado | 80304 | United States | ||
| National Jewish Medical and Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Total Knee Arthroplasty (TKA) Traditional | Procedure | 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. |
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| Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
| Denver |
| Colorado |
| 80206 |
| United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg\m^2 |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Quadriceps Muscle Force | Posted | Mean | Standard Deviation | Nm/kg | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
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| Secondary | Functional Performance: 6 Minute Walk (6MW) Distance | Posted | Mean | Standard Deviation | Meters | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
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| Primary | Knee Range of Motion | Knee Flexion Active Range of Motion (AROM) | Posted | Mean | Standard Deviation | degrees | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
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| Secondary | Functional Performance: Stair Climb Test | This outcome measures the time (seconds) it takes to climb up and back down 12 steps. | Posted | Mean | Standard Deviation | Seconds | Measured pre-operatively; post-surgery at 4 weeks and 12 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 1 | 22 | 10 | 22 | ||
| EG001 | 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. | 0 | 22 | 22 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolus | Respiratory, thoracic and mediastinal disorders |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femoral Notching | Surgical and medical procedures |
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| Retained Cement | Surgical and medical procedures |
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| Heterotopic Ossification | Surgical and medical procedures |
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| Retained Drill Bit | Surgical and medical procedures |
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| Intra-Operative Fracture | Surgical and medical procedures | Medial Condyle Fracture |
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| Hematoma\Excessive Bleeding | Blood and lymphatic system disorders |
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| Cellulitis | Skin and subcutaneous tissue disorders |
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| Poor Bone Quality | General disorders | Prevented full weight bearing after surgery |
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| Urinary Tract Infection | Infections and infestations | Post-op |
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| Transient EKG Abnormality | Cardiac disorders | Post-op |
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| Hypersensitivity to Light Touch | Nervous system disorders |
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| Surgical Malalignment | Surgical and medical procedures | Greater than 4 degrees of varus post-op |
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Small sample size; Relatively short follow-up time
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer Stevens-Lapsley | University of Colorado Denver, Anschutz Medical Center | 303-724-9170 | Jennifer.Stevens-Lapsley@ucdenver.edu |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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| Male |
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| Quadriceps Strength 12 weeks Postop |
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