UMIN-CTR Clinical Trial

Public title

Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis

Acronym

Outcome study of Trabecular Metal Primary Hip Prosthesis

Scientific Title

Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis

Scientific Title:Acronym

Outcome study of Trabecular Metal Primary Hip Prosthesis

Region

Japan

Condition

secondary coxarthrosis with developmental dysplasia of the hip (DDH)

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate bone remodeling in total hip arthroplasty (THA) with Trabecular Metal Primary Hip Prosthesis as below;
Primary objective:
To compare changes of bone mineral density (BMD) around Trabecular Metal™ Primary Hip Prosthesis to that around VerSys® HA-TCP FMT Stem for proving superiority of Trabecular Metal™ Primary Hip Prosthesis
Secondary objective:
To explore bone remodeling around shell covered with Trabecular Metal™

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Bone mineral density (BMD) assessments:
BMD around stem with Gruen classification and around cup with 4 ROIs will be measured within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. The change of BMD from immediately post-operation will be calculated at each visit.

Key secondary outcomes

Clinical Assessment:
JOA Score will be evaluated at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively.
Radiographic Assessment:
X-ray will be taken before operation, within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. Evaluation of stress shielding, spot welds or others will be performed around stem with Gruen classification and around cup with DeLee & Charenly classification. If there is a gap between shell covered with Trabecular Metal™ and acetabulum, the time will be investigated until the gap is completely filled with bone.
Questionnaire:
Health status will be investigated with EQ-5D at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively.
Safety Evaluation:
When an adverse event or a product failure for which a causal relationship to the investigational or comparative device cannot be ruled out occurs, principal investigator or sub-investigator should report the event or the failure in accordance with the procedure outlined in section 14 of the protocol.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

THA with Trabecular Metal™ Primary Hip Prosthesis

Interventions/Control_2

THA with VerSys HA-TCP Fiber Metal Taper Stem

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Primary THA
2) Age (at the day of obtainment of the consent): 20 to 75 years old
3) Sex:Both males and females
4) Patient who is able to provide the consent and to sign the consent form
5) Patient who is willing and able to complete the scheduled follow-up evaluations described in the protocol

Key exclusion criteria

1) Patient who is skeletally immature
2) Patient with loss of abductor musculature in the affected limb
3) Patient with poor bone stock (e.g., steroid-induced metabolic bone disease)
4) Patient with poor skin coverage around the hip joint
5) Patient with neuromuscular disease (e.g., Charcot's joint) in the affected limb
6) Patient with infection symptoms (e.g., osteomyelitis in proximal femur, pyrogenetic infection of the hip)
7) Patient with stove pipe Dorr type C femur
8) Patient with osteoradionecrosis of the acetabulum
9) Patient with systematic or local infection
10) Patient with vascular deficiency in the affected limb that may lead to inadequate skeletal fixation
11) Patient who is not able to independently walk before THA
12) Patient who is suspected to have metal allergy
13) Patient who is pregnant, suspected pregnancy or planned to get pregnant during the study period
14) Patient with any comorbidity (e.g. dementia, schizophrenia, depression, panic disorder, generalized anxiety disorder, etc.) which may affect the ability of informed consent or completion of assessments
15) Patient who have planned to undergo THA, TKA, osteotomy or any operation of lower extremities within 6 months after enrollment
16) Patient who underwent THA, TKA, osteotomy or any operation of lower extremities less than 6 months before enrollment
17) Patient having other medical condition who is considered to be inappropriate by the investigator to participate in the study

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Koichi Uchiyama

Organization

Zimmer K.K.

Division name

Clinical Affairs

Zip code

Address

1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan

TEL

03-6402-6610

Email

Name of contact person

1st name
Middle name
Last name	Chie Nishizawa

Organization

Zimmer K.K.

Division name

Clinical Affairs

Zip code

Address

1-17, Toranomon 4-chome, Minato-ku, Tokyo 105-0001, Japan

TEL

03-6402-6764

Homepage URL

Email

Institute

Zimmer K.K.

Institute

Department

Personal name

Organization

Zimmer K.K.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

九州大学病院（福岡県）、愛媛大学医学部附属病院（愛媛）、三重大学病院（三重県）、藤田保健衛生大学病院（愛知県）、昭和大学藤が丘病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）/
Kyushu University Hospital (Fukuoka), Ehime University Hospital (Ehime), Mie University Hospital (Mie), Fujita Health University Hospital (Aichi), Showa University Fujigaoka Hospital (kanagawa), okohama City University Medical Center (kanagawa)

Date of disclosure of the study information

2012

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2012

Year

08

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

20

Day

Last follow-up date

2016

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

09

Month

27

Day

Last modified on

2015

Year

01

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010543