Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis
Conditions
Keywords
Osteoarthritis, Osteoarthritis, Knee, Osteonecrosis, Arthritis, Knee Arthritis, Knee Replacement
Brief summary
This study will compare alignment criteria in the Oxford Partial Knee using conventional instrumentation and Signature Custom Guides in order to determine if the use of the Signature Custom Guides results in a higher percentage of knees achieving optimal alignment. The study will also examine outcomes with high volume surgeons (\>30 cases/year) and low volume surgeons (\<10 cases/year).
Detailed description
The primary objectives of this global clinical study are to collect data to assess the following clinical evidence parameters that were gathered from Biomet team members and KOL globally for this product: 1. Evaluate the performance & accuracy of the Oxford Partial Knee System with Signature Knee Guide in comparison to conventional instrumentation. 2. Compare the accuracy of Signature Guides between two user profiles: high volume surgeons & low volume surgeons in a global mix. 3. Assess potential economic & efficiency advantages in the short term and long-term: OR efficiency, patient quality of life and activity, clinical outcomes.
Interventions
DEVICESignature Custom Guides
Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
PROCEDUREConventional Instrumentation
Traditional partial knee arthroplasty without the use of Signature technology.
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Intended for use in individuals with osteoarthritis or Avascular necrosis limited to the medial compartment of the knee that is also lacking patellofemoral or lateral compartment disease. * Use of cementless femoral fixation is permitted outside of the United States if it complies with all local, state, and/or national and international regulations. The same technique must be used consistently throughout the course of the study with all cases * Patients 21 and over
Exclusion criteria
* Use of Cementless Fixation in the United States * Infection, sepsis or osteomyelitis * Use in lateral compartment of the knee * Rheumatoid arthritis or other forms of inflammatory joint disease * Revision of failed prosthesis, failed upper tibial osteotomy, or post traumatic arthritis after tibial plateau fracture * Insufficiency of the collateral, anterior, or posterior cruciate ligaments which would preclude stability of the device. * Disease or damage to the lateral compartment of the knee * Uncooperative patient or patient with neurologic disorders who is incapable of following directions * Osteoporosis in the United States / Insufficient bone stock outside the United States * Metabolic disorders which may impair bone formation * Osteomalacia * Distant foci of infections which may spread to implant site * Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram * Vascular insufficiency, muscular atrophy, neuromuscular disease. * Incomplete or deficient soft tissue surrounding the knee. * Charcot's disease * A fixed varus deformity (not passively correctable) of greater than 15 degrees * A flexion deformity greater than 15 degrees. * Non-staged Bilateral patients * Patients who refuse, cannot, or should not receive a CT or MRI. Since patients are randomized into treatment groups, all patients must be able to receive an MRI (should follow local MRI screening protocol). This excludes patients who have metal artifacts in the knee, patients who are too large to fit into the knee coil, patients with pacemakers, patients unable to lie still for the duration of the MRI, and patients who are claustrophobic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Knees Achieving Optimal Alignment | 12 weeks | Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EQ5D Score | 1 Year | EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome. |
| Leg Alignment Femoral Flexion/Extension | Directly Postoperative | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle |
| Instruments Used During Surgery | Operative | Number of Instrument cases used to complete index surgery. |
| Knee Society Functional Score | 1 Year | Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions |
| Leg Alignment Tibial Varus/Valgus | Directly Postoperative | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle |
| Blood Loss | Right after surgery (up to 2 hours after surgery) | Blood Loss during surgery |
| Knee Society Objective Score | 1 Year | Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions |
| Oxford Knee Score | 1 Year | Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome |
| Leg Alignment Tibial Flexion/Extension | Directly Postoperative | Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle |
| Leg Alignment Femoral Varus/Valgus | Directly Postoperative | Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle |
Countries
United States
Participant flow
Pre-assignment details
Bi-lateral treatment was not recorded. Each treated knee is counted as 1 participant.
Participants by arm
| Arm | Count |
|---|---|
| Signature Custom Guides Oxford Partial Knee implanted using Signature Custom Guides
Signature Custom Guides: Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI). | 126 |
| Conventional Instrumentation Oxford Partial Knee implanted using Conventional Instrumentation
Conventional Instrumentation: Traditional partial knee arthroplasty without the use of Signature technology. | 127 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study surgery not performed | 7 | 6 |
| Overall Study | Study terminated early due to low enrollment | 126 | 127 |
Baseline characteristics
| Characteristic | Signature Custom Guides | Conventional Instrumentation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 45 Participants | 49 Participants | 94 Participants |
| Age, Categorical Between 18 and 65 years | 77 Participants | 77 Participants | 154 Participants |
| Age, Continuous | 63.2 Years STANDARD_DEVIATION 10 | 62.5 Years STANDARD_DEVIATION 9.1 | 62.9 Years STANDARD_DEVIATION 9.7 |
| Region of Enrollment Australia | 6 participants | 4 participants | 10 participants |
| Region of Enrollment Europe | 25 participants | 47 participants | 72 participants |
| Region of Enrollment United States | 95 participants | 71 participants | 166 participants |
| Sex: Female, Male Female | 56 Participants | 68 Participants | 124 Participants |
| Sex: Female, Male Male | 70 Participants | 54 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 133 | 0 / 133 |
| other Total, other adverse events | 12 / 133 | 18 / 133 |
| serious Total, serious adverse events | 3 / 133 | 6 / 133 |
Outcome results
Primary
Percentage of Knees Achieving Optimal Alignment
Percentage of Knees Achieving Optimal Alignment defined as a difference of 5 or less between all target and observed angles.
Time frame: 12 weeks
Population: Data from all patients as treated
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Signature Custom Guides | Percentage of Knees Achieving Optimal Alignment | 45 percentage of total |
| Conventional Instrumentation | Percentage of Knees Achieving Optimal Alignment | 29 percentage of total |
Secondary
Blood Loss
Blood Loss during surgery
Time frame: Right after surgery (up to 2 hours after surgery)
Population: All patients as treated for which blood loss is recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Blood Loss | 81.9 ml | Standard Deviation 84.5 |
| Conventional Instrumentation | Blood Loss | 54.8 ml | Standard Deviation 73 |
Secondary
EQ5D Score
EuroQol 5D Quality of Life score. Range from 0 to 1 with 1 being the best outcome.
Time frame: 1 Year
Population: All patients, as treated, reaching the 1 year follow up datapoint with EQ5D score completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | EQ5D Score | 0.88 units on a scale from 0 to 1 | Standard Deviation 0.15 |
| Conventional Instrumentation | EQ5D Score | 0.9 units on a scale from 0 to 1 | Standard Deviation 0.19 |
Secondary
Instruments Used During Surgery
Number of Instrument cases used to complete index surgery.
Time frame: Operative
Population: All patients as treated
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Instruments Used During Surgery | 4.2 Instrument cases | Standard Deviation 0.76 |
| Conventional Instrumentation | Instruments Used During Surgery | 3.8 Instrument cases | Standard Deviation 0.97 |
Secondary
Knee Society Functional Score
Functional Score from Knee Society Score. These are 3 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time frame: 1 Year
Population: All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score score completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Knee Society Functional Score | 88.1 units on a scale | Standard Deviation 18.2 |
| Conventional Instrumentation | Knee Society Functional Score | 91.8 units on a scale | Standard Deviation 14.2 |
Secondary
Knee Society Objective Score
Objective score from Knee Society Score. These are 7 of the 10 items. Scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions
Time frame: 1 Year
Population: All patients, as treated, reaching the 1 year follow up datapoint with Knee Society Score completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Knee Society Objective Score | 93.3 units on a scale from 0 to 100 | Standard Deviation 16.3 |
| Conventional Instrumentation | Knee Society Objective Score | 95.0 units on a scale from 0 to 100 | Standard Deviation 17.5 |
Secondary
Leg Alignment Femoral Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time frame: Directly Postoperative
Population: All patients as treated with post-operative CT collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Leg Alignment Femoral Flexion/Extension | 3.48 Degrees | Standard Deviation 2.7 |
| Conventional Instrumentation | Leg Alignment Femoral Flexion/Extension | 4.59 Degrees | Standard Deviation 3.34 |
Secondary
Leg Alignment Femoral Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Femoral Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time frame: Directly Postoperative
Population: All patients as treated with post-operative CT collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Leg Alignment Femoral Varus/Valgus | 3.55 Degrees | Standard Deviation 2.7 |
| Conventional Instrumentation | Leg Alignment Femoral Varus/Valgus | 4.75 Degrees | Standard Deviation 3.53 |
Secondary
Leg Alignment Tibial Flexion/Extension
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Flexion/Extension angle as measured via CT-scan directly post-operative, vs target angle
Time frame: Directly Postoperative
Population: All patients as treated with post-operative CT collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Leg Alignment Tibial Flexion/Extension | 2.47 Degrees | Standard Deviation 2.06 |
| Conventional Instrumentation | Leg Alignment Tibial Flexion/Extension | 2.96 Degrees | Standard Deviation 2.04 |
Secondary
Leg Alignment Tibial Varus/Valgus
Mechanical Leg Alignment of Components (degrees): Difference of Tibial Varus/Valgus angle as measured via CT-scan directly post-operative, vs target angle
Time frame: Directly Postoperative
Population: All patients as treated with post-operative CT collected
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Leg Alignment Tibial Varus/Valgus | 4.04 Degrees | Standard Deviation 2.41 |
| Conventional Instrumentation | Leg Alignment Tibial Varus/Valgus | 4.10 Degrees | Standard Deviation 2.39 |
Secondary
Oxford Knee Score
Oxford Knee Score (OKS). Scored from 0 to 48 with 0 being the worst possible outcome and 48 being the best outcome
Time frame: 1 Year
Population: All patients, as treated, reaching the 1 year follow up datapoint with Oxford Knee Score completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Signature Custom Guides | Oxford Knee Score | 42.6 units on a scale | Standard Deviation 6.1 |
| Conventional Instrumentation | Oxford Knee Score | 44.0 units on a scale | Standard Deviation 4.9 |