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This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides.
This is a prospective, non-randomized, study of the clinical outcomes of participants that receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using ShapeMatch® Cutting Guides. Sub-study A aims to quantify the reproducibility of intra-operatively positioning the cutting guides onto the affected femoral and tibial joint surfaces.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shapematch Cutting Guides | Other | The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shapematch Cutting Guides | Device | Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study |
| Measure | Description | Time Frame |
|---|---|---|
| Repeatability of Cutting Guide Position | Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement. | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. |
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Inclusion Criteria:
Exclusion Criteria:
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55 knees enrolled - 3 censored from analysis due to major protocol deviations = 52 knees in study analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Shapematch Cutting Guides | The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline measurements are available only for the 24 participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Shapematch Cutting Guides | The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. |
| 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 |
| 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 | Repeatability of Cutting Guide Position | Repeatability of cutting guide position on the distal femur and proximal tibia assessed by repeated measures using computer navigation system for total knee replacement, assessed intra-operatively. Placement of the cutting guides by the surgeon was determined by recording the position of the cutting guide when placed by the same surgeon multiple times. The intraclass correlation coefficient (ICC) was calculated for each positioning parameter. This included femoral and tibial varus/valgus,flexion/extension, medial resection, lateral resection and rotation. ICC agreement categories:>0.75 excellent agreement; 0.75-0.4 good or fair agreement; <0.4 poor agreement. | Posted | Number | 95% Confidence Interval | intraclass correlation coefficient (ICC) | Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes. | Knees | Participants |
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Intraoperative- participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Elective procedures not included.e.g.non-study joint replacement/revision, rotator cuff repair,carpal tunnel release,cataract,intra-ocular & bunion procedures,total shoulder repair,laminectomy,microdiscectomy,breast reduction,cervical spine fusion,& mid/flat-foot surgery.Industry standard AE terms not used;specific AE terms not used for all AEs.
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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 | Shapematch Cutting Guides | The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting. They are intended for single use only. Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| non-operative site | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Holly Solomon | Stryker SP | +61 2 9467 1072 | Holly.Solomon@stryker.com |
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| Use of incorrect measurement technique |
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| Data not recorded |
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| MRI contraindication exclusion |
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| 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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The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.
They are intended for single use only.
|
|
| 2 |
| 52 |
| 0 |
| 52 |
| Operative site | Infections and infestations | Non-systematic Assessment |
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Discloser must give at least 40 days notice to Sponsor including a copy of the proposed publication. The Sponsor can then provide comments (which Discloser is not bound to follow), request delay of publication by no more than 120 days to allow for Sponsor to protect its intellectual property, or request that the Discloser remove certain proprietary or confidential information from the study (other than the results of the study).