A DEXA Clinical Study to Evaluate the Osteointegrative Po... | NCT02635581

Studies
A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™

NCT02635581

Sponsor

Limacorporate S.p.a

Status

Completed

Last Update Posted

Mar 2, 2016Estimated

Enrollment

84Actual

Phase

Not Applicable

Conditions

Primary Total Hip Replacement

Interventions

Delta TT acetabular cup

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Dec 2015Actual

Completion Date

Dec 2015Actual

First Submitted Date

Dec 15, 2015

First Submission Date that Met QC Criteria

Dec 16, 2015

First Posted Date

Dec 21, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2016

Last Update Posted Date

Mar 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84Actual

Label	Type	Description	Intervention Names
DELTA TT	Experimental		Device: Delta TT acetabular cup

Name	Type	Description	Arm Group Labels	Other Names
Delta TT acetabular cup	Device		DELTA TT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan		From baseline to 5 year Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Harris Hip Score (HHS)		From baseline to 5 year Follow-up
SF-36 score		From baseline to 5 year Follow-up

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMI< 40 kg/m2
Indication suitable to the implantation of Delta TT acetabular cup (First implant)
Idiopathic osteoarthritis
Avascular necrosis
Post-traumatic arthritis
Presence of sufficient periacetabular bone stock
Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
Written informed consent

Exclusion Criteria:

Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
Patients aged 76 or older
Haemophilic disease
Femur neck fracture
Insulin Dependent Diabetes Mellitus (IDDM)
Severe kidney failure (grade 4)
Not responder Hypo- or Hyperthyroidism
Paget's disease
Tumours
Active or suspicious infections
Neurosensory deficits or neuromuscular diseases
Severe and impairing vascular diseases
Known incompatibility or allergy to products materials
Woman with pregnancy or childbearing capacity or breast-feeding
Subjects already enrolled in other clinical trials

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Leo Massari	Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna		Cona	Ferrara	44124	Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica II