Knee Osteoarthritis
Conditions
Keywords
total knee arthroplasty, osteoarthritis, ceramic bearing, zirconia
Brief summary
The aim of this study is to provide evidence that the safety and effectiveness of the ceramic femoral component of the Gem Total Knee System is similar to FDA approved implants used in total knee replacement surgery. The hypotheses to be tested are that the investigational and control groups are equivalent in terms of patient success rate and complication-free rate.
Detailed description
Due to excellent biocompatibility and wear characteristics, ceramics have a long history of success in total hip arthroplasty (THA). Use of a ceramic-polyethylene wear couple in total knee arthroplasty (TKA) has shown promising laboratory and early clinical results. The use of ceramics in this study is intended to address long-term failure of TKA due to osteolysis associated with polyethylene wear debris.
Interventions
DEVICEzirconia femoral component
total knee arthroplasty performed using implant with zirconia femoral component
DEVICEcobalt chrome femoral component
total knee arthroplasty performed using implant with cobalt chrome femoral component
Sponsors
Kinamed Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Skeletally mature * Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint * Stable or reconstructable collateral and posterior cruciate ligaments * Correctable deformity * Intact quadriceps and hamstrings mechanisms * Patella bone thick enough (at least 15 mm) after resection
Exclusion criteria
* Previous TKA * Bilateral knee arthritis * Non-availability for follow-up * Mental incompetence or confinement * Patients being treated with other investigational devices for same disorder * Infection * Osteoporosis, acute renal failure, or other disorders known to affect bone quality * Charcot's or Paget's disease * Patient physical condition preventing use of appropriate size implant * Disease conditions affecting blood supply to knee * Insufficient bone quality or quantity * Physical condition predisposing implant to extreme loads * History of septic knee arthritis * History of drug abuse
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Score at 2 Years Post Operation | within 2 years | The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) \> 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score \> 80 was used as a criterion to assess success. |
Participant flow
Recruitment details
Recruited during pre-op TKA clinical exam during year 2004.
Participants by arm
| Arm | Count |
|---|---|
| 1: Zirconia Femoral zirconia femoral component : total knee arthroplasty performed using implant with zirconia femoral component | 2 |
| 2: CoCr Femoral cobalt chrome femoral component : total knee arthroplasty performed using implant with cobalt chrome femoral component | 2 |
| Total | 4 |
Baseline characteristics
| Characteristic | 2: CoCr Femoral | 1: Zirconia Femoral | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 1 Participants | 1 Participants |
| Age Continuous | 65.5 years STANDARD_DEVIATION 4.94 | 62.5 years STANDARD_DEVIATION 13.4 | 64 years STANDARD_DEVIATION 8.45 |
| Region of Enrollment United States | 2 participants | 2 participants | 4 participants |
| Sex: Female, Male Female | 1 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 2 | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 |
Outcome results
Primary
Knee Score at 2 Years Post Operation
The criterion used to assess the outcome is a Knee Score (as defined by Knee Society Clinical Rating System) \> 80 points at two-years follow-up. This scoring system is defined in the following paper: Insall JN, Dorr LD, Scott RD, and Scott WN (1989). Rationale of the Knee Society clinical rating system. Clin Orthop(248): 13-4. The scale ranges from minimum of 0 (worst) to maximum of 100 (best). Knee Score \> 80 was used as a criterion to assess success.
Time frame: within 2 years
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 1: Zirconia Femoral | Knee Score at 2 Years Post Operation | 91 units on a scale |
| 2: CoCr Femoral | Knee Score at 2 Years Post Operation | 89 units on a scale |