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| ID | Type | Description | Link |
|---|---|---|---|
| 20131148 | Other Identifier | WIRB Protocol |
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The Investigation will be conducted as a single-submission, multi-center study with approval from and in compliance of the Western Institutional Review Board (WIRB).
The overall objective of this Investigation is to assess the safety and effectiveness of the Robotic Arm Interactive Orthopedic System (RIO) Total Knee Arthroplasty Application. Specifically, the study objectives are classified as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic Assisted Total Knee Arthroplasty | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robotic Arm Assisted Total Knee Arthroplasty | Device | The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon. |
| Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively. |
| Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | 3 Month Post Op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative | Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Gustke, MD | Florida Orthopedic Institute, Tampa General Hospital | Principal Investigator |
| Thomas Coon, MD | Coon Joint Replacement Institute, St. Helena Hospital | Principal Investigator |
| Stefan Kreuzer, MD | Memorial Bone and Joint Research Foundation, Memorial Hermann Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coon Joint Replacement Institue; St. Helena Hospital | St. Helena | California | 94574 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Robotic Assisted Total Knee Arthroplasty | Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. "Participants" throughout this posting is equivalent to the number of knees. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Robotic Assisted Total Knee Arthroplasty | Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | participants = knees. | Posted | Number | intra-operative complications | Subject will be assessed for these complications intra-operatively. The assessment occurs after the surgeon has completed the surgical procedure, but while the subject is still in the operating room with the surgeon. |
|
Subject enrollment to end of study.
Participants = knees
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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 | Robotic Assisted Total Knee Arthroplasty | Participants who underwent primary total knee arthroplasty using the Mako robotic arm system. Note regarding serious AEs: Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient's overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthrofibrosis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Conditt | MAKO Surgical Corp. | 7132408675 | michael.conditt@stryker.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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|
| pre-op plan, 3 Month Post Op |
| Participants With Limb Alignment Difference <4.38 Degrees | The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure. | Pre-op Plan, 3 Month Post Op |
| Pre-Op, 3 Month Post Op [change assessed between the two time periods] |
| Florida Orthopedic Institute |
| Tampa |
| Florida |
| 33637 |
| United States |
| Memorial Bone and Joint Research Foundation; Memorial Hermann Memorial City Medical Center | Houston | Texas | 77024 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | participants = knees. | Posted | Number | intra-operative complications | Subjects will be assessed for incidence of intra-operative complications at the conclusion of their hospital stay, or an average of 3 days post-operatively. |
|
|
|
| Primary | Intra-Operative Complications | Surgeon assessment of standardized TKA complications (Healey et al. CORR 2012) both intra-operatively and at short term follow up. The nine complications relating to soft tissue damage for primary TKA that were assessed as part of this study were as follows: Blood loss, Vascular injury, MCL injury, Periprosthetic fracture, Extensor mechanism disruption, Patellofemoral dislocation, Tibiofemoral dislocation, Neurological impairment, Instability. | participants = knees. | Posted | Number | intra-operative complications | 3 Month Post Op |
|
|
|
|
| Secondary | Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative | Radiographic limb alignment of the operative knee according to the technique defined by Barrack et al. was assessed at the 3 month post-operative follow-up by two independent reviewers. The measured post-operative limb alignment was to be compared to the planned pre-operative limb alignment as extracted from the system log file. | Of the 89 patients who received a robotic assisted total knee arthroplasty as part of the IDE, 2 patients were excluded from analysis for the Secondary Endpoint only due to issues related to the accurate measurement of limb alignment from the radiographs available (not for reasons involving the surgical procedure or clinical outcomes). | Posted | Mean | Standard Deviation | degrees | pre-op plan, 3 Month Post Op |
|
|
|
| Secondary | Participants With Limb Alignment Difference <4.38 Degrees | The difference between the actual 3 month limb alignment was compared to the pre-op planned alignment. Any measurement difference <4.38 was considered a success; >4.38 degrees was considered a failure. | Participants = knees | Posted | Count of Participants | Participants | Pre-op Plan, 3 Month Post Op |
|
|
|
|
| Other Pre-specified | Patient Satisfaction - Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) | The WOMAC collects information specific to osteoarthritis outcomes. The patient-response questionnaire uses a visual analog scale for pain, measuring factors of general pain, stiffness, and function. Each question is scored from 0 to 4 for each set of factors, with 0 indicating no pain, stiffness, or limit in function, and 4 indicating extreme pain, stiffness, or limit in function. Total WOMAC scores range from 0 to 96 with lower values representing better outcomes. The posted mean, noted as a negative number, represents the mean DECREASE in total WOMAC score from pre-operative to 3 month post-operative patient assessment. | participants = knees. | Posted | Mean | Standard Deviation | units on a scale | Pre-Op, 3 Month Post Op [change assessed between the two time periods] |
|
|
|
|
| 9 |
| 100 |
| 0 |
| 100 |
| Adhesions | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pulmonary Embolism | Vascular disorders | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |