Trial Outcomes & Findings for Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A (NCT NCT02516163)
NCT ID: NCT02516163
Last Updated: 2016-01-12
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
Results posted on
2016-01-12
Participant Flow
55 knees enrolled - 3 censored from analysis due to major protocol deviations = 52 knees in study analysis.
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
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52
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Overall Study
COMPLETED
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24
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Overall Study
NOT COMPLETED
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28
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Reasons for withdrawal
| Measure |
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.
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|---|---|
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Overall Study
Withdrawal by Subject
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1
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Overall Study
Failed MRI/incorrect MRI protocol
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11
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Overall Study
Unfit/delay in surgery
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3
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Overall Study
Use of incorrect measurement technique
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5
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Overall Study
Data not recorded
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2
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Overall Study
MRI contraindication exclusion
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6
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Baseline Characteristics
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A
Baseline characteristics by cohort
| Measure |
Shapematch Cutting Guides
n=24 Participants
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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|---|---|
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Age, Continuous
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66.2 years
STANDARD_DEVIATION 7.7 • n=99 Participants
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Sex: Female, Male
Female
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11 Participants
n=99 Participants
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Sex: Female, Male
Male
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13 Participants
n=99 Participants
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Region of Enrollment
Australia
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24 participants
n=99 Participants
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PRIMARY outcome
Timeframe: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.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.
Outcome measures
| Measure |
Shapematch Cutting Guides
n=24 Knees
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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|---|---|
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Repeatability of Cutting Guide Position
Femur varus/valgus ICC
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0.990 intraclass correlation coefficient (ICC)
Interval 0.98 to 0.995
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Repeatability of Cutting Guide Position
Femur flexion/extension ICC
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0.963 intraclass correlation coefficient (ICC)
Interval 0.929 to 0.983
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Repeatability of Cutting Guide Position
Femur medial resection ICC
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0.936 intraclass correlation coefficient (ICC)
Interval 0.879 to 0.97
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Repeatability of Cutting Guide Position
Femur lateral resection ICC
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0.910 intraclass correlation coefficient (ICC)
Interval 0.832 to 0.957
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Repeatability of Cutting Guide Position
Femur rotation ICC
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0.993 intraclass correlation coefficient (ICC)
Interval 0.987 to 0.997
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Repeatability of Cutting Guide Position
Tibia varus/valgus ICC
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0.994 intraclass correlation coefficient (ICC)
Interval 0.989 to 0.997
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Repeatability of Cutting Guide Position
Tibia flexion/extension ICC
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0.961 intraclass correlation coefficient (ICC)
Interval 0.925 to 0.982
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Repeatability of Cutting Guide Position
Tibia medial resection ICC
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0.889 intraclass correlation coefficient (ICC)
Interval 0.795 to 0.946
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Repeatability of Cutting Guide Position
Tibia lateral resection ICC
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0.940 intraclass correlation coefficient (ICC)
Interval 0.887 to 0.972
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Repeatability of Cutting Guide Position
Tibia rotation ICC
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0.997 intraclass correlation coefficient (ICC)
Interval 0.995 to 0.999
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Adverse Events
Shapematch Cutting Guides
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Shapematch Cutting Guides
n=52 participants at risk
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
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
non-operative site
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1.9%
1/52 • Number of events 1 • 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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Infections and infestations
Operative site
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1.9%
1/52 • Number of events 1 • 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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Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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).
- Publication restrictions are in place
Restriction type: OTHER