Arthroplasties, Replacement, Knee
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEShapematch 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 and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study
Sponsors
Stryker South Pacific
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* The patient is a male or non-pregnant female between the ages of 50-90. * The patient requires a primary total knee replacement and is indicated for computer-assisted surgery. * The patient has a primary diagnosis of osteoarthritis (OA). * The patient has intact collateral ligaments. * The patient is able to undergo MRI scanning of the affected limb. * The patient has signed the study specific, HREC-approved, Informed Consent document. * The patient is willing and able to comply with the specified pre-operative and post-operative clinical and radiographic evaluations.
Exclusion criteria
* The patient has a history of total, unicompartmental reconstruction or fusion of the affected joint. * The patient has had a high tibial osteotomy or femoral osteotomy. * The patient is morbidly obese (BMI ≥ 40). * The patient has a deformity which will require the use of stems, wedges or augments in conjunction with the Triathlon Total Knee System. * The patient has a varus/valgus malalignment ≥ 15° (relative to mechanical axis). * The patient has a fixed flexion deformity ≥ 15°. * The patient has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device. * The patient has a systemic or metabolic disorder leading to progressive bone deterioration. * The patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements. * The patient has a cognitive impairment, an intellectual disability or a mental illness. * The patient is pregnant. * The patient has metal hardware present in the region of the hip, knee or ankle (as this is known to create geometrical distortion in the region of the implant). * The patient has any known contraindications for undergoing assessment by MRI (e.g. ferrous implants, metallic clips, magnetically activated implanted devices such as cardiac pacemakers, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Repeatability of Cutting Guide Position | 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. |
Participant flow
Pre-assignment details
55 knees enrolled - 3 censored from analysis due to major protocol deviations = 52 knees in study analysis.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Data not recorded | 2 |
| Overall Study | Failed MRI/incorrect MRI protocol | 11 |
| Overall Study | MRI contraindication exclusion | 6 |
| Overall Study | Unfit/delay in surgery | 3 |
| Overall Study | Use of incorrect measurement technique | 5 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Shapematch Cutting Guides |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment Australia | 24 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 2 / 52 |
Outcome results
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.
Time frame: Intraoperative - participants were followed for the duration of the operation, an average of 1 hour and 50 minutes.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Femur varus/valgus ICC | 0.990 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Femur flexion/extension ICC | 0.963 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Femur medial resection ICC | 0.936 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Femur lateral resection ICC | 0.910 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Femur rotation ICC | 0.993 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Tibia varus/valgus ICC | 0.994 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Tibia flexion/extension ICC | 0.961 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Tibia medial resection ICC | 0.889 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Tibia lateral resection ICC | 0.940 intraclass correlation coefficient (ICC) |
| Shapematch Cutting Guides | Repeatability of Cutting Guide Position | Tibia rotation ICC | 0.997 intraclass correlation coefficient (ICC) |