UMIN-CTR Clinical Trial

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

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Basic information

Public title

Hydroxyapatite-coated Stem Outcome and Pain Evaluation

Acronym

HOPE Study

Scientific Title

Hydroxyapatite-coated Stem Outcome and Pain Evaluation

Scientific Title:Acronym

HOPE Study

Region

Japan


Condition

Condition

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

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

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.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change in Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JHEQ) Total Score between baseline and 730 days post-operation.

Key secondary outcomes

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.


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

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.

Key exclusion criteria

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.

Target sample size

808


Research contact person

Name of lead principal investigator

1st name Henji
Middle name
Last name Ohzono

Organization

Amagasaki Chuou Hospital

Division name

Orthopedic surgery

Zip code

660-0893

Address

1-15-6 Amagasai City,Hyogo Pref,660-0893 Japan

TEL

06-6499-3045

Email

ohzono@chuoukai.or.jp


Public contact

Name of contact person

1st name Ryo
Middle name
Last name Hasegawa

Organization

Smith & nephew KK

Division name

North Asia Clinical Strategy and Operation

Zip code

105-5114

Address

World Trade Center Building South Tower 2 Chome-4-1 Hamamatsucho, Minato City, Tokyo 105-5114 Japan

TEL

07031245766

Homepage URL


Email

Ryo.Hasegawa@smith-nephew.com


Sponsor or person

Institute

Kansai Rousai Hospital

Institute

Department

Personal name



Funding Source

Organization

smith & nephew KK

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kansai Rousai Hospital Clinical Institutional Review Board

Address

3-1-6 Inabaso,Amagasaki,Hyogo 660-8511,Japan

Tel

06-6416-1221

Email

chiken@kansaih.johas.go.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2017 Year 07 Month 01 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000031555

Number of participants that the trial has enrolled

637

Results

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.

Results date posted

2023 Year 12 Month 20 Day

Results Delayed


Results Delay Reason

Due to delays in data collection as a result of Covid19

Date of the first journal publication of results


Baseline Characteristics

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).

Participant flow

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.

Adverse events

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.

Outcome measures

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.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 04 Month 18 Day

Date of IRB

2017 Year 04 Month 25 Day

Anticipated trial start date

2017 Year 08 Month 01 Day

Last follow-up date

2022 Year 05 Month 01 Day

Date of closure to data entry

2023 Year 01 Month 19 Day

Date trial data considered complete

2023 Year 03 Month 22 Day

Date analysis concluded

2023 Year 04 Month 14 Day


Other

Other related information

Multicenter, prospective, observational, cohort study


Management information

Registered date

2017 Year 06 Month 01 Day

Last modified on

2023 Year 12 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031555


Research Plan
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
Registered date File name
2023/10/16 paperCRF Hope Study Ver1..pdf

Research case data
Registered date File name