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This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.
This study is designed as comparative, sequential, non-randomized, multi-center investigation.
Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments.
The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKA with RUI | Active Comparator | 44 Subjects will receive TKA with RUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Reusable instruments (RUI). |
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| TKA with SUI | Experimental | 44 Subjects will receive TKA with SUI per their study doctor's standard of care. These 44 subjects will receive the TKA using Single Use Instruments (SUI). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATTUNE TKA with ATTUNE RUI | Device | ATTUNE TKA with ATTUNE RUI |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | 3 Months Post Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | 3 Months Post Surgery | |
| Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | 3 Months Post Surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Verdonna Huey, MS,BSN,CCRP | DePuy Synthes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Torrey Pines | La Jolla | California | 92037 | United States | ||
| Geisinger Wyoming Valley |
Consent was taken for 102 knees, 14 subjects were deemed ineligible for the study. This left 88 subjects in the safety population that could be randomised for the study.
The first patient was operated on 16 November 2015 and recruitment lasted for 37 months with the last patient operated on 19 December 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | RUI (Reuseable Instrumentation) | Patients were operated on using Reusable TKA Instrumentation |
| FG001 | SUI (Single-Use Instrumentation) | Patients were operated on using Single-Use TKA Instrumentation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Pre-Operative |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 19, 2018 | Mar 27, 2020 |
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| ATTUNE TKA with ATTUNE SUI | Device | ATTUNE TKA with ATTUNE SUI |
|
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| Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation | 3 Months Post Surgery |
| Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation | 3 Months Post Surgery |
| Number of Participants With Treatment-related Adverse Events | 3 Months Post Surgery |
| Wilkes-Barre |
| Pennsylvania |
| 18702 |
| United States |
| Spire Liverpool Hospital | Liverpool | L18 1HQ | United Kingdom |
| Clifton Park Hospital | York | YO30 5RA | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| 3 Months Follow-up |
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All subjects who received the study device.
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| ID | Title | Description |
|---|---|---|
| BG000 | RUI (Reuseable Instrumentation) | Patients were operated on using Reusable TKA Instrumentation |
| BG001 | SUI (Single-Use Instrumentation) | Patients were operated on using Single-Use TKA Instrumentation |
| 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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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | All patients with readable radiographs who were enrolled without major protocol violations | Posted | Mean | Standard Deviation | Degrees | 3 Months Post Surgery | Radiographs | Radiographs |
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| Secondary | Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | All patients with readable radiographs who were enrolled without major protocol violations | Posted | Mean | Standard Deviation | Degrees | 3 Months Post Surgery | Radiographs | Radiographs |
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| Secondary | Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation | All patients with readable radiographs who were enrolled without major protocol violations | Posted | Mean | Standard Deviation | Degrees | 3 Months Post Surgery | Radiographs | Radiographs |
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| Secondary | Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation | All patients with readable radiographs who were enrolled without major protocol violations | Posted | Mean | Standard Deviation | Degrees | 3 Months Post Surgery | Radiographs | Radiographs |
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| Secondary | Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation | All patients with readable radiographs who were enrolled without major protocol violations | Posted | Mean | Standard Deviation | Degrees | 3 Months Post Surgery | Radiographs | Radiographs |
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| Secondary | Number of Participants With Treatment-related Adverse Events | All subjects who received the study device | Posted | Number | Participants | 3 Months Post Surgery |
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All participants had reached the 3 month follow-up visit at the time of uploading adverse events.
Final assessment of adverse events were classified by system organ class in lieu of specific adverse event terms.
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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 | RUI (Reuseable Instrumentation) | Patients were operated on using Reusable TKA Instrumentation | 0 | 44 | 1 | 44 | 5 | 44 |
| EG001 | SUI (Single-Use Instrumentation) | Patients were operated on using Single-Use TKA Instrumentation | 0 | 44 | 0 | 44 | 2 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Musculoskeletal | Musculoskeletal and connective tissue disorders | MedDRA 17.0 | Systematic Assessment |
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| Vascular | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Infections and infestations | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Immune System Disorder | Immune system disorders | MedDRA 17.0 | Systematic Assessment |
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DePuy reserves the right to review the contents of publications in advance.The PI may freely disclose the trial results only after DePuy has been given the opportunity of reviewing the proposed results communications at least 30 days prior to the intended release.DePuy will advise the PI of any perceived errors,omissions or corrections but PI will retain final editorial control. In case of disagreement, DePuy and PI will make every effort to meet in order to discuss and resolve any issues.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kirstin Cosgrove | DePuy Ortho Joint US | 800-827-7003 | kcosgro1@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 6, 2019 | Mar 27, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| United States |
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| Radiographs |
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| Radiographs |
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| Radiographs |
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| Radiographs |
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