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The study will evaluate the clinical performance of the rotating platform and fixed bearing implants through patient questionnaires, outcomes scoring and radiographic assessment.
The study will evaluate the clinical performance of rotating platform and fixed bearing cruciate ligament substituting implants by obtaining a series of primary TKAS. Patients will receive either the P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System or P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System and assignment is randomized.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | P.F.C.® Sigma™ Rotating Platform Cruciate Substituting Knee System |
|
| 2 | Active Comparator | P.F.C.® Sigma™ Fixed Cruciate Substituting Knee System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Knee Arthroplasty | Device | Rotating Platform (RP) Cruciate Substituting Knee System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Society Score | The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | On-going to end of study | |
| Revisions | On-going to end of study | |
| Medical Imaging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tammy L O'Dell, EMT, CCRA | DePuy Orthopaedics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greensboro | North Carolina | 27408 | United States | |||
Immediately before surgery, the implant type was determined according to the randomization schedule. Before treatment assignment, consented subjects could be excluded from the trial based on results of pre-operative clinical evaluations and/or radiographs, as per the exclusion criteria in the clinical investigation plan.
Between April 2001 and October 2002, 106 subjects were recruited and enrolled at 3 US clinics by orthopaedic surgeons. Each study site could enroll up to 50 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rotating Platform | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. |
| FG001 | Fixed Bearing |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Total knee replacement | Device | Fixed Cruciate Substituting Knee System |
|
|
| Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| SF-12 Patient Outcomes | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
| Austin |
| Texas |
| 78746 |
| United States |
| Lakewood | Washington | 98499 | United States |
P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rotating Platform | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. |
| BG001 | Fixed Bearing | P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| 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 | Knee Society Score | The Knee Society Score (KSS) is comprised to two sections (each worth 100 points) for a maximum 200 points. One section is the Knee Society Clinical Score (KSCS) - points are given for pain, motion, and stability and points are deducted for flexion contracture, extension lag, and misalignment. The other section is the Knee Society Functional Score (KSFS) - points are assigned for walking distances and climbing stairs and points are deducted for use of walking aids. For each section, a score of 80-100 = excellent, 70-79 = good; 60-69 = fair; and < 60 = poor. | Posted | Mean | Standard Deviation | Scores on a scale | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. |
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| Secondary | Complications | Not Posted | On-going to end of study | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Revisions | Not Posted | On-going to end of study | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Medical Imaging | Not Posted | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. | Participants | ||||||||||||||||||||||||||||||||||||||||||
| Secondary | SF-12 Patient Outcomes | Not Posted | Pre-operative, 6 and 12 months and annually thereafter for at least 5 years. | Participants |
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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 | Rotating Platform | P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion. | 15 | 77 | 6 | 77 | ||
| EG001 | Fixed Bearing | P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base. | 6 | 72 | 8 | 72 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pulmonary Embolism | Vascular disorders |
| |||
| GI Bleeding | Gastrointestinal disorders |
| |||
| Death | General disorders |
| |||
| Manipulation under anesthesia | Musculoskeletal and connective tissue disorders |
| |||
| Intraoperative medial collateral ligament injury | Musculoskeletal and connective tissue disorders |
| |||
| Infection - superficial | Skin and subcutaneous tissue disorders |
| |||
| Adhesions | Musculoskeletal and connective tissue disorders |
| |||
| Deep Vein Thrombosis, Pulmonary Embolism | Cardiac disorders |
| |||
| Delayed wound healing | Injury, poisoning and procedural complications |
| |||
| Constipation/fecal impaction | Gastrointestinal disorders |
| |||
| Deep vein thrombosis | Vascular disorders |
| |||
| Peripheral neuropathy or vascular disorder | Cardiac disorders |
| |||
| Pain | General disorders |
| |||
| General | General disorders |
| |||
| Deep infection | Infections and infestations |
| |||
| Cardiac Arrhythmia | Cardiac disorders |
| |||
| Necrosis/wound slough | Injury, poisoning and procedural complications |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adhesions | Musculoskeletal and connective tissue disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy O'Dell, EMT, CCRA | DePuy Orthopaedics | 574-372-7104 | TOdell2@its.jnj.com |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001172 | Arthritis, Rheumatoid |
| D001171 | Arthritis, Juvenile |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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 |
|
| 12 Months |
|
| 24 Months |
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| 36 Months |
|
| 48 Months |
|
| 60 Months |
|