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Enrollment of the subject could not reach statistically required number.
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The primary objectives of this clinical study include:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIOLOX delta head | Experimental | 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. |
|
| CoCr head | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Stem | Device | JMDN classification/Class III device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Immediate postoperative and 2 year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 month postoperative |
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Inclusion Criteria:
Exclusion Criteria:
Absolute contraindications include: infection, sepsis, and osteomyelitis.
Relative contraindications include:
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| Name | Affiliation | Role |
|---|---|---|
| Hirotsugu Ohashi, M.D., Ph.D. | Saiseikai Nakatsu Hospital | Principal Investigator |
| Arihiko Kanaji, M.D., Ph.D. | Keio University | Principal Investigator |
| Katsufumi Uchiyama, M.D., Ph.D. | Kitasato University School of Medicine | Principal Investigator |
| Hironori Kaneko, M.D., Ph.D. | Kitasato University Kitasato Institute Hospital | Principal Investigator |
| Koichi Kinoshita, M.D., Ph.D. | Fukuoka University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka University School of Medicine | Fukuoka | Fukuoka | 814-0180 | Japan | ||
| Kitasato University School of Medicine |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Participants, whose x-ray taken at 2 year follow-up visit being available. | Posted | Mean | Standard Deviation | millimeter | Immediate postoperative and 2 year postoperatively |
|
3 year after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraoperative Trochanteric Fracture | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Surgical Procedure related intraoperative fracture of Trochanter of Femur. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Manager of Clinical Affairs | Zimmer Biomet G.K. | +81-3-6402-6610 | takahito.nakai@zimmerbiomet.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 29, 2012 | Jan 6, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Acetabular Cup | Device | JMDN classification: Class III device |
|
|
| Acetabular Liner | Device | JMDN classification: Class III device |
|
|
| 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. |
| 1 year postoperative |
| 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. | 2 year postoperative |
| 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. | 3 year postoperative |
| 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. | 6 month postoperative |
| 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. | 1 year postoperative |
| 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. | 2 year postoperative |
| 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. | 3 year postoperative |
| 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. | 6 month postoperative |
| 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. | 1 year postoperative |
| 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. | 2 year postoperative |
| 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. | 3 year postoperative |
| Sagamihara |
| Kanagawa |
| 252-0374 |
| Japan |
| Saiseikai Nakatsu Hospital | Osaka | 530-0012 | Japan |
| Kitasato University Kitasato Institute Hospital | Tokyo | 108-8642 | Japan |
| Keio University School of Medicine | Tokyo | 160-8582 | Japan |
| Poor X-ray quality |
|
| Withdrawal by Subject |
|
| inappropriate implant used |
|
| bone anatomy did not meet study criteria |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Harris Hip Score | 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. | Mean | Standard Deviation | score on scale |
|
| WOMAC osteoarthritis index | 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. | Mean | Standard Deviation | score on scale |
|
| UCLA Activity Score | 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. | Mean | Standard Deviation | score on scale |
|
| OG001 | 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 |
|
|
| 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. | 1 patient in BIOLOX delta head group and 13 patients in CoCr head group missed collecting Harris Hip Score at 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
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| 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. | 1 patient in BIOLOX delta head group and 6 patients in CoCr head group missed collecting Harris Hip Score at 1 year visit. | Posted | Mean | Standard Deviation | score on a scale | 1 year postoperative |
|
|
|
| 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. | 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed collecting Harris Hip Score at 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | 2 year postoperative |
|
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| 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. | 12 patients in BIOLOX delta head group and 12 patients in CoCr head group missed collecting Harris Hip Score at 3 year visit. | Posted | Mean | Standard Deviation | score on a scale | 3 year postoperative |
|
|
|
| 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. | 6 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting WOMAC questionnaire at 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
|
| 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. | 6 patients in BIOLOX delta head group and 13 patients in CoCr head group missed colleting WOMAC questionnaire at 1 year visit. | Posted | Mean | Standard Deviation | score on a scale | 1 year postoperative |
|
|
|
| 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. | 9 patients in BIOLOX delta head group and 16 patients in CoCr head group missed colleting WOMAC questionnaire at 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | 2 year postoperative |
|
|
|
| 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. | 14 patients in BIOLOX delta head group and 17 patients in CoCr head group missed colleting WOMAC questionnaire at 3 year visit. | Posted | Mean | Standard Deviation | score on a scale | 3 year postoperative |
|
|
|
| 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. | 4 patients in BIOLOX delta head group and 12 patients in CoCr head group missed colleting UCLA Activity score at 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 6 month postoperative |
|
|
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| 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. | 2 patients in BIOLOX delta head group and 8 patients in CoCr head group missed colleting UCLA Activity score at 1 year visit. | Posted | Mean | Standard Deviation | score on a scale | 1 year postoperative |
|
|
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| 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. | 3 patients in BIOLOX delta head group and 9 patients in CoCr head group missed colleting UCLA Activity score at 2 year visit. | Posted | Mean | Standard Deviation | score on a scale | 2 year postoperative |
|
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| 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. | 12 patients in BIOLOX delta head group and 11 patients in CoCr head group missed colleting UCLA Activity score at 3 year visit. | Posted | Mean | Standard Deviation | score on a scale | 3 year postoperative |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| 2 |
| 62 |
| EG001 | 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 | 0 | 67 | 0 | 67 | 1 | 67 |
|
| Femoral Nerve Palsy | Nervous system disorders | Non-systematic Assessment | Surgical Procedure related femoral nerve palsy. Symptom was disappeared although no specific treatment was conducted. |
|
| Inappropriate femoral stem position | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Intraoperative stem insertion to prepared femoral canal was not optimal, so it was revised two weeks after primary surgery. |
|
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| D012216 |
| Rheumatic Diseases |