Unique ID issued by UMIN | UMIN000027594 |
---|---|
Receipt number | R000031555 |
Scientific Title | Hydroxyapatite-coated Stem Outcome and Pain Evaluation |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2023/12/20 10:47:15 |
Hydroxyapatite-coated Stem Outcome and Pain Evaluation
HOPE Study
Hydroxyapatite-coated Stem Outcome and Pain Evaluation
HOPE Study
Japan |
Non-inflammatory degenerative hip joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of pelvis, and diastrophic variant
Orthopedics |
Others
NO
Total hip arthroplasty surgery using HA coated stem for Japanese patients and clinical results and X-ray evaluation after 2year of surgery,clearly demonstrate the efficacy and safety of HA coated stem for Japanese patients.
Safety,Efficacy
Change in Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) Total Score between baseline and 730 days post-operation.
1)Cumulative revision rate for each femoral stem at each follow-up visit.
2)Change in Harris Hip Score (HHS) between baseline and each follow-up visit.
3)Change in the 3 dimensions of the JHEQ between baseline and each follow-up visit.
4)Change in pain as measured by the Visual Analogue Scale (VAS) between baseline and each follow-up visit.
5)Changes in EQ-5D-5L and in EQ-5D-5L-derived Quality Adjusted Life Years (QALY) between baseline and each follow-up visit.
6)Radiographic outcomes.
7)Comparison of revision rate, HHS, 3 dimensions and total score of JHEQ, pain, and EQ-5D-5L including QALY between subjects with and without a diagnosis of osteoporosis at each of the follow-up visits.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1)Has provided written informed consent for study participation.
2)Patients of Japanese descent, of either gender, 20 years of age or older.
3)A candidate for total hip arthroplasty (THA) due to NIDJD or any of its composite diagnoses such as osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
4)Willing and able to comply with study visit schedule including all follow-up visits.
5)Has no disease or conditions that in the opinion of the Investigator would compromise the study or would pose a risk due to study participation.
1)Acute or chronic infection, local or systemic.
2)Severe muscle, nerve, or vascular diseases that endanger the extremity.
3)Has previously received THA in the index joint.
4)Any of the following conditions in the contralateral joint:
Has received THA as a revision for a failed procedure.
Has received THA that is not fully healed and well-functioning in the opinion of the Investigator.
5)Current diagnosis of immunosuppressive disorder.
6)History of cancer within 5 years of screening.
7)Known allergy to any component of the study device.
8)Conditions known to interfere with THA survival or outcomes including vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal disease, neuromuscular disease.
9)Current diagnosis of fibromyalgia.
10)Body Mass Index (BMI) > 40.
11)Currently enrolled or has participated in a clinical research study (drug, device, or biologic) within 30 days of screening.
808
1st name | Henji |
Middle name | |
Last name | Ohzono |
Amagasaki Chuou Hospital
Orthopedic surgery
660-0893
1-15-6 Amagasai City,Hyogo Pref,660-0893 Japan
06-6499-3045
ohzono@chuoukai.or.jp
1st name | Ryo |
Middle name | |
Last name | Hasegawa |
Smith & nephew KK
North Asia Clinical Strategy and Operation
105-5114
World Trade Center Building South Tower 2 Chome-4-1 Hamamatsucho, Minato City, Tokyo 105-5114 Japan
07031245766
Ryo.Hasegawa@smith-nephew.com
Kansai Rousai Hospital
smith & nephew KK
Profit organization
Kansai Rousai Hospital Clinical Institutional Review Board
3-1-6 Inabaso,Amagasaki,Hyogo 660-8511,Japan
06-6416-1221
chiken@kansaih.johas.go.jp
NO
2017 | Year | 07 | Month | 01 | Day |
NA
Unpublished
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031555
637
Across all stem types, the mean increase in JHEQ scores from preoperative to 2 years was 44.3 (95% CI: 42.7, 45.8) and this difference was found to be statistically significant (p-value < 0.001). Similar significant increases in JHEQ scores were found within each of the four stem types and for each study visit.
2023 | Year | 12 | Month | 20 | Day |
Due to delays in data collection as a result of Covid19
Overall 637 hips were enrolled with a subject mean age was 68.3 years (SD=9.9, range 29-88) with 529 (83.0%) were female and 108 (17.0%) were male. The mean BMI was 24.2 (SD 3.8, 13.4-39.1). For ANTHOLOGY, subject mean age was 68.9 years (SD=9.2, range 45-86) with 164 (91.1%) were female and 16 (8.9%) were male. The mean BMI was 24.2 (SD 4.0, 15.6-38.0). For SL-PLUS, subject mean age was 68.7 years (SD=11.2, range 29-88) with 155 (78.7%) were female and 42 (21.3%) were male. The mean BMI was 23.8 (SD 3.7, 13.4-39.1). For POLARSTEM Collarless, subject mean age was 66.6 years (SD=9.2, range 40-88) with 135 (77.6%) were female and 39 (22.4%) were male. The mean BMI was 24.8 (SD 3.7, 16.8-35.5). For POLARSTEM Collared, subject mean age was 69.7 years (SD=9.1, range 50-88) with 75 (87.2%) were female and 11 (12.8%) were male. The mean BMI was 24.2 (SD 3.8, 16.0-33.3).
Eight hundred and eight (808) subjects/hips were planned (202 hips in each of the 4 femoral stem groups). This study was non-comparative and the same size was justified based on a precision approach, i.e., based on the number of subjects expected and assumptions on the data distribution and what level of precision placed on the data results from the study. The target number of hips could not be enrolled within the planned enrollment period, and 637 hips (ANTHOLOGY HA n=180 hips, SL-PLUS MIA HA n=197 hips, POLARSTEM Collarless n=174 hips, and POLARSTEM Collared n=86 hips) were enrolled and analyzed. At the time, the enrollment period was not extended as it was deemed statistically unproblematic that the number of subjects had not been reached the target numbers. Therefore, the level of precision for this study was less than planned. Overall, 638 hips were enrolled into the study at 22 sites. One hip (ID 14020) was terminated prior to study treatment on Investigator judgment that Simulation was performed using 3D preoperative planning software, but it did not fit. Of the 637 hips receiving the study device (the safety analysis set), 79 hips were discontinued early from the study.
A total of thirty-seven (37) of the 637 enrolled hips treated with ANTHOLOGY HA [n=9 (5%)], SL-PLUS MIA HA [n=15 (7.6%)], POLARSTEM Collarless [n=10 (5.7%)], and POLARSTEM Collared [n=3 (3.5%)] femoral stems experienced 40 AEs cumulatively by the 2-year postoperative follow-up visit and/or study termination. There were 21 SAEs (which included 2 deaths), 9 serious adverse device effects (SADEs), and 0 unanticipated serious adverse device effect (USADE) reported up through the 2-year postoperative follow-up and/or study termination.
Primary Efficacy Result:
Overall for all stem types, the average increase in JHEQ score from preoperative to 2 year was 44.3 (95% CI: 42.7, 45.8), this difference was found to be statistically significant (p-value < 0.001). Similar significant increases in JHEQ scores were seen within each of the 4 stem types and by each study visit.
Secondary Efficacy Results:
1: Of the 637 implanted hips, there were 5 revisions (0.8%) occurring in the 24-month follow-up period. All 5 of the revisions were seen prior to the 6-month follow-up visit and occurred with product stems: Anthology (n=1), SL-PLUS (n=2), and POLARSTEM Collarless (n=2). At 24 months, the Kaplan-Meier estimate of survivorship was 99.2% (95% CI: 98.1% to 99.7%).
2: For the HHS, there was an overall (all 4 stem types) preoperative mean of 49.3 (SD=14.1, range 0-92) and at 24-month follow-up a mean of 94.4 (SD=7.1, range 51-100). The change from Baseline to the 2-year follow-up visit demonstrated a statistically significant
p-value of < 0.001.
3: The JHEQ sub-scores for pain, movement, and mental state were analyzed for all visits and by stem type. These sub-scores revealed the Pain score increased from a preoperative mean of 8.0 (SD=5.3, range 0-28) to 24 month mean of 25.4 (SD=4.2, range 2-28), the Movement score increased from a preoperative mean of 4.5 (SD=4.2, range 0-25) to 24-month mean of 17.5 (SD=7.1, range 0-28), and the Mental score increased from a preoperative mean of 9.3 (SD=6.2, range 0-28) to 24 month mean of 23.1 (SD=6.0, range 0-28).
4: For the EQ-5D-5L Index and VAS scores at preoperative and all follow-up visits overall as well as by stem type, the index score showed that all hips had a preoperative mean of 0.49 (SD=0.18, range -0.11-1) and at 24-month follow-up a mean of 0.85 (SD=0.16, range 0.16-1). The VAS score demonstrated that all hips had a preoperative mean of 57.4 (SD=23.8, range 0-100) and at 24-month follow-up a mean of 85.1 (SD=14.6, range 20-100). The change from Baseline to the 2-year follow-up visit demonstrated a statistically significant p-value of < 0.001 overall.
5: On the pain drawing assessment (4 locations, for both operated and un-operated hips) at preoperative and follow-up visits, the operated hips demonstrated that pain in the groin was reported in n=514 (83.3%) at preoperative which decreased to n=115 (20.0%) at the 6-month follow-up.
6: For the radiology evaluation postoperatively, the following findings were noted:
* The coronal plane stem alignment showed 496 hips (77.9%) to be in neutral position, the cup inclination angle showed a mean of 40.2 degrees, and there were 570 hips (89.5%) demonstrated no cup polar gap (gap between acetabular component and acetabular bone in the polar cup region).
* The direction between the trochanter and stem was found to be at a primarily a positive angle in 544 hips (91.9%) immediately postoperative and continued in 485 hips (92.6%) by the 2-year postoperative visit. As well, the distance between the trochanter and stem was found to be overall a mean of 9.3 mm (SD=7.5) immediately postoperative and a mean of 10.0 mm (SD=7.7) by the 2-year postoperative visit.
* The majority of hips did not demonstrate radiolucent lines in either the coronal or sagittal planes, coronal or sagittal plane cortical hypertrophy, osteolysis, or an acetabular gap.
Completed
2017 | Year | 04 | Month | 18 | Day |
2017 | Year | 04 | Month | 25 | Day |
2017 | Year | 08 | Month | 01 | Day |
2022 | Year | 05 | Month | 01 | Day |
2023 | Year | 01 | Month | 19 | Day |
2023 | Year | 03 | Month | 22 | Day |
2023 | Year | 04 | Month | 14 | Day |
Multicenter, prospective, observational, cohort study
2017 | Year | 06 | Month | 01 | Day |
2023 | Year | 12 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031555
Research Plan | |
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Registered date | File name |
2023/10/16 | HOPE スタディ 研究実施計画書 ver3.0 181109 clean.pdf |
Research case data specifications | |
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Registered date | File name |
2023/10/16 | paperCRF Hope Study Ver1..pdf |
Research case data | |
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Registered date | File name |