Hip Osteoarthritis
Conditions
Keywords
Only Female, Age between 20 - 75 at the time of operation
Brief summary
The primary objectives of this clinical study include: * Evaluate E1 Wear including early bedding-in process, clinical outcomes on patients who received Total Hip Arthroplasty with E1 * Compare E1 wear used with CoCr and Biolox Delta heads
Detailed description
This study is designed as PROSPECTIVE, RANDOMIZED, MULTI-CENTER Study to compare two different materials (CoCr and Delta ceramic) articulating against E1 Highly Crosslinked polyethylene in Hip Replacement. Patient population is 160 (80 each). Follow-up period is 10 year postoperatively. E1 liners with thickness of 4.8mm at 45 degrees position (load bearing direction) will be used in all cases. Randomization will occur via random number generator by 4 blocks randomization.
Interventions
DEVICEFemoral Stem
JMDN classification/Class III device
DEVICEAcetabular Cup
JMDN classification: Class III device
DEVICEAcetabular Liner
JMDN classification: Class III device
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Osteoarthritis * Age between 20 - 75 at the time of operation * Patients with limited co-morbidity -ASA I-III * Patients must be able to understand instructions and be willing to return for follow up
Exclusion criteria
* In accordance with approved Absolute and Relative Contraindications for use in participating countries for E1 liner and Delta Ceramic and CoCr femoral head hip system System. Absolute contraindications include: infection, sepsis, and osteomyelitis. Relative contraindications include: 1. uncooperative patient or patient with neurologic disorders who are incapable of following directions, 2. osteoporosis, 3. metabolic disorders which may impair bone formation, 4. osteomalacia, 5. distant foci of infections which may spread to the implant site, 6. rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram, and 7. vascular insufficiency, muscular atrophy, or neuromuscular disease. 8. pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period | Immediate postoperative and 2 year postoperatively | Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Harris Hip Score at 1 Year Follow-up Visit | 1 year postoperative | Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome. |
| Harris Hip Score at 2 Year Follow-up Visit | 2 year postoperative | Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome. |
| Harris Hip Score at 3 Year Follow-up Visit | 3 year postoperative | Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome. |
| WOMAC Osteoarthritis Index at 6 Month Follow-up Visit | 6 month postoperative | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| WOMAC Osteoarthritis Index at 1 Year Follow-up Visit | 1 year postoperative | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| Harris Hip Score at 6 Month Follow-up Visit | 6 month postoperative | Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome. |
| WOMAC Osteoarthritis Index at 3 Year Follow-up Visit | 3 year postoperative | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
| UCLA Activity Score at 6 Month Follow-up Visit | 6 month postoperative | University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level. |
| UCLA Activity Score at 1 Year Follow-up Visit | 1 year postoperative | University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level. |
| UCLA Activity Score at 2 Year Follow-up Visit | 2 year postoperative | University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level. |
| UCLA Activity Score at 3 Year Follow-up Visit | 3 year postoperative | University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level. |
| WOMAC Osteoarthritis Index at 2 Year Follow-up Visit | 2 year postoperative | The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BIOLOX Delta Head Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
Biolox delta head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device | 62 |
| CoCr Head Uncemented Femoral Stem is inserted into femoral medullary canal. Uncemented Acetabular Cup is inserted into acetabular cavity with or without fixation screw(s).
Acetabular Liner, which is made of E1 highly crosslinked polyethylene, is fitted into Acetabular cup.
CoCr head is inserted onto the taper of the Femoral stem, and is articulating against Acetabular Liner made of E1.
Femoral Stem: JMDN classification/Class III device
Acetabular Cup: JMDN classification: Class III device
Acetabular Liner: JMDN classification: Class III device | 67 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | bone anatomy did not meet study criteria | 1 | 1 |
| Overall Study | inappropriate implant used | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Poor X-ray quality | 7 | 4 |
| Overall Study | Surgery on contra-lateral hip | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CoCr Head | Total | BIOLOX Delta Head |
|---|---|---|---|
| Age, Continuous | 61.94 years STANDARD_DEVIATION 7.26 | 61.92 years STANDARD_DEVIATION 7.18 | 61.90 years STANDARD_DEVIATION 7.16 |
| Harris Hip Score | 52.63 score on scale STANDARD_DEVIATION 11.67 | 53.83 score on scale STANDARD_DEVIATION 11.68 | 55.11 score on scale STANDARD_DEVIATION 11.65 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 67 Participants | 129 Participants | 62 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 67 participants | 129 participants | 62 participants |
| Sex: Female, Male Female | 67 Participants | 129 Participants | 62 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| UCLA Activity Score | 3.28 score on scale STANDARD_DEVIATION 1.1 | 3.12 score on scale STANDARD_DEVIATION 1.04 | 2.95 score on scale STANDARD_DEVIATION 0.95 |
| WOMAC osteoarthritis index | 41.24 score on scale STANDARD_DEVIATION 15.29 | 41.00 score on scale STANDARD_DEVIATION 16.13 | 40.75 score on scale STANDARD_DEVIATION 17.09 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 67 |
| other Total, other adverse events | 2 / 62 | 1 / 67 |
| serious Total, serious adverse events | 0 / 62 | 0 / 67 |
Outcome results
Primary
Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period
Vector wear, which is defined as movement (difference of femoral prosthetic head positions) between immediate postoperative and 2 years postoperative periods. There is no lower and upper limit, actual measured results. The outcome can be negative value.
Time frame: Immediate postoperative and 2 year postoperatively
Population: Participants, whose x-ray taken at 2 year follow-up visit being available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period | 0.42 millimeter | Standard Deviation 1.08 |
| CoCr Head | Polyethylene Wear Between Immediate Postoperative and 2 Year Postoperative Period | 0.15 millimeter | Standard Deviation 0.7 |
Secondary
Harris Hip Score at 1 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Time frame: 1 year postoperative
Population: 1 patient in BIOLOX delta head group and 6 patients in CoCr head group missed collecting Harris Hip Score at 1 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | Harris Hip Score at 1 Year Follow-up Visit | 95.23 score on a scale | Standard Deviation 6.1 |
| CoCr Head | Harris Hip Score at 1 Year Follow-up Visit | 94.52 score on a scale | Standard Deviation 6.76 |
Secondary
Harris Hip Score at 2 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Time frame: 2 year postoperative
Population: 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed collecting Harris Hip Score at 2 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | Harris Hip Score at 2 Year Follow-up Visit | 96.15 score on a scale | Standard Deviation 5.44 |
| CoCr Head | Harris Hip Score at 2 Year Follow-up Visit | 96.28 score on a scale | Standard Deviation 5.69 |
Secondary
Harris Hip Score at 3 Year Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Time frame: 3 year postoperative
Population: 12 patients in BIOLOX delta head group and 12 patients in CoCr head group missed collecting Harris Hip Score at 3 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | Harris Hip Score at 3 Year Follow-up Visit | 96.30 score on a scale | Standard Deviation 4.56 |
| CoCr Head | Harris Hip Score at 3 Year Follow-up Visit | 96.82 score on a scale | Standard Deviation 6.03 |
Secondary
Harris Hip Score at 6 Month Follow-up Visit
Harris Hip Score is Physician rating score to evaluate hip disabilities. Score domains are pain, function, absence of deformity and range of hip motion. Minimum possible score is 0 and maximum possible score is 100. Higher score means better outcome.
Time frame: 6 month postoperative
Population: 1 patient in BIOLOX delta head group and 13 patients in CoCr head group missed collecting Harris Hip Score at 6 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | Harris Hip Score at 6 Month Follow-up Visit | 92.67 score on a scale | Standard Deviation 8.05 |
| CoCr Head | Harris Hip Score at 6 Month Follow-up Visit | 92.61 score on a scale | Standard Deviation 7.92 |
Secondary
UCLA Activity Score at 1 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Time frame: 1 year postoperative
Population: 2 patients in BIOLOX delta head group and 8 patients in CoCr head group missed colleting UCLA Activity score at 1 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | UCLA Activity Score at 1 Year Follow-up Visit | 5.45 score on a scale | Standard Deviation 1.52 |
| CoCr Head | UCLA Activity Score at 1 Year Follow-up Visit | 5.03 score on a scale | Standard Deviation 1.27 |
Secondary
UCLA Activity Score at 2 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Time frame: 2 year postoperative
Population: 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed colleting UCLA Activity score at 2 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | UCLA Activity Score at 2 Year Follow-up Visit | 5.53 score on a scale | Standard Deviation 1.38 |
| CoCr Head | UCLA Activity Score at 2 Year Follow-up Visit | 5.31 score on a scale | Standard Deviation 1.3 |
Secondary
UCLA Activity Score at 3 Year Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Time frame: 3 year postoperative
Population: 12 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting UCLA Activity score at 3 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | UCLA Activity Score at 3 Year Follow-up Visit | 5.42 score on a scale | Standard Deviation 1.49 |
| CoCr Head | UCLA Activity Score at 3 Year Follow-up Visit | 5.43 score on a scale | Standard Deviation 1.36 |
Secondary
UCLA Activity Score at 6 Month Follow-up Visit
University of California, Los Angeles (UCLA) activity score is questionnaire to assess intensity of patients' activity. The score ranges from 1 to 10 (1 point increment), higher score means higher activity level.
Time frame: 6 month postoperative
Population: 4 patients in BIOLOX delta head group and 12 patients in CoCr head group missed colleting UCLA Activity score at 6 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | UCLA Activity Score at 6 Month Follow-up Visit | 5.19 score on a scale | Standard Deviation 1.42 |
| CoCr Head | UCLA Activity Score at 6 Month Follow-up Visit | 4.75 score on a scale | Standard Deviation 1.28 |
Secondary
WOMAC Osteoarthritis Index at 1 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 1 year postoperative
Population: 6 patients in BIOLOX delta head group and 13 patients in CoCr head group missed colleting WOMAC questionnaire at 1 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | WOMAC Osteoarthritis Index at 1 Year Follow-up Visit | 9.86 score on a scale | Standard Deviation 13.52 |
| CoCr Head | WOMAC Osteoarthritis Index at 1 Year Follow-up Visit | 9.57 score on a scale | Standard Deviation 9.23 |
Secondary
WOMAC Osteoarthritis Index at 2 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 2 year postoperative
Population: 9 patients in BIOLOX delta head group and 16 patients in CoCr head group missed colleting WOMAC questionnaire at 2 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | WOMAC Osteoarthritis Index at 2 Year Follow-up Visit | 7.85 score on a scale | Standard Deviation 8.88 |
| CoCr Head | WOMAC Osteoarthritis Index at 2 Year Follow-up Visit | 7.80 score on a scale | Standard Deviation 10.32 |
Secondary
WOMAC Osteoarthritis Index at 3 Year Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 3 year postoperative
Population: 14 patients in BIOLOX delta head group and 17 patients in CoCr head group missed colleting WOMAC questionnaire at 3 year visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | WOMAC Osteoarthritis Index at 3 Year Follow-up Visit | 8.29 score on a scale | Standard Deviation 9.31 |
| CoCr Head | WOMAC Osteoarthritis Index at 3 Year Follow-up Visit | 6.84 score on a scale | Standard Deviation 8 |
Secondary
WOMAC Osteoarthritis Index at 6 Month Follow-up Visit
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is used in evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items. The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. Usually a sum of the scores for all three subscales gives a The total WOMAC score ranged from 0 to 96. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time frame: 6 month postoperative
Population: 6 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting WOMAC questionnaire at 6 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIOLOX Delta Head | WOMAC Osteoarthritis Index at 6 Month Follow-up Visit | 9.27 score on a scale | Standard Deviation 9.75 |
| CoCr Head | WOMAC Osteoarthritis Index at 6 Month Follow-up Visit | 10.43 score on a scale | Standard Deviation 9.62 |