Metal on Metal Versus Metal on Highly Crossed Linked Poly... | NCT01422564

Studies
Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

NCT01422564

Sponsor

Nova Scotia Health Authority

Status

Terminated

Last Update Posted

May 15, 2015Estimated

Enrollment

41Actual

Phase

Phase 4

Conditions

Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Congenital Dysplasia of the Hip
Ankylosing Spondylitis
Post-traumatic; Arthrosis
Injury of Hip and Thigh

Interventions

Metal on Metal Hip System
Highly Cross Linked Polyethylene cup System

Countries

Not provided

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

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Components were recalled by Depuy

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Dec 2010Actual

Completion Date

Dec 2010Actual

First Submitted Date

Aug 12, 2011

First Submission Date that Met QC Criteria

Aug 23, 2011

First Posted Date

Aug 24, 2011Estimated

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

May 14, 2015

Last Update Posted Date

May 15, 2015Estimated

Name	Class
University Health Network, Toronto	OTHER

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

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Metal on Metal	Active Comparator	Metal on Metal articulation system	Device: Metal on Metal Hip System
HCLPC	Active Comparator	THA using Highly Cross Linked Polyethylene cup System	Device: Highly Cross Linked Polyethylene cup System

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Metal on Metal Hip System	Device	Total hip arthroplasty with a metal on metal component system	Metal on Metal

Measure	Description	Time Frame
Revision Rate		4 years

Measure	Description	Time Frame
Wear and osteolysis		5-15 years
Harris Hip Score		immediate post-op, 6 months, 1 year, 2 years, 4 years
Dislocation Rate

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and non-pregnant female subjects 65 years of age or older
Subjects undergoing cementless hip arthroplasty. If a press fit metal articulation acetabulum is not possible; the modular cup system will be utilized with screw fixation and a metal head of the greatest diameter deemed appropriate and safe for the patient will be utilized.(At the discretion of the surgeon). The cup in this situation may have a metal or poly articulation. The patient will be followed as an intent to treat (the patient will be evaluated and included in the group as randomized)
Subjects with, but not limited to, original diagnoses of osteoarthritis, avascular necrosis, rheumatoid arthritis, congenital dysplasia of the hip, ankylosing spondylitis, posttraumatic arthritis, and traumatic injury to the hip joint.
Subjects who are able and willing to understand the conditions of informed consent, to participate in the study according to the protocol for the length of the expected term of follow-up, and to follow their physician's directions.

Exclusion Criteria:

Subjects undergoing hip arthroplasty using a cemented femoral component and/or a bipolar prosthesis.
Subjects with gross obesity, >45% over ideal body weight for age and height. Refer to Appendix A, Obesity Table.
Subjects with active infections.
Subjects with malignancy in the area of the involved hip joint.
Subjects with a neuromuscular deficit that interferes with the subject's ability to limit weight bearing or places an extreme load on the implant during the healing period.
Subjects with a diagnosis of Fibromyalgia
Female subjects who are pregnant or may be pregnant.
Subjects whom, as judged by the surgeon, are not capable of understanding the informed consent or the requirements of the protocol, or are reasonably unlikely to be compliant with the prescribed postoperative routine and the follow-up evaluation schedule.
Subjects who have a known sensitivity to device materials.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Ross K Leighton, MD	Nova Scotia Health Authority	Principal Investigator

Type	Date	Date Unknown
Release	Nov 8, 2022
Reset	Nov 29, 2022
Release	Feb 7, 2023

ID	Term
D010003	Osteoarthritis
D010020	Osteonecrosis
D001172	Arthritis, Rheumatoid
D006618	Hip Dislocation, Congenital
D013167	Spondylitis, Ankylosing
D025981	Hip Injuries

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D001847	Bone Diseases
D009336	Necrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases
D000082602	Developmental Dysplasia of the Hip
D009139	Musculoskeletal Abnormalities
D000013	Congenital Abnormalities
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D000844	Ankylosis
D014947	Wounds and Injuries

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Nov 8, 2022			Nov 29, 2022
Feb 7, 2023			Feb 8, 2023
Aug 21, 2024			Aug 22, 2024