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Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem (MOM)

Primary Purpose

Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Status

Terminated

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Metal on Metal Hip System

Highly Cross Linked Polyethylene cup System

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Metal on Metal

HCLPC

Arm Description

Metal on Metal articulation system

THA using Highly Cross Linked Polyethylene cup System

Outcomes

Primary Outcome Measures

Revision Rate

Secondary Outcome Measures

Wear and osteolysis

Harris Hip Score

Dislocation Rate

Complication Rate

All complications

Gait Analysis

Using the Walkabout portable gait monitor

Metal Ions

Full Information

NCT ID

NCT01422564

First Posted

August 12, 2011

Last Updated

May 14, 2015

Sponsor

Nova Scotia Health Authority

Collaborators

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT01422564

Brief Title

Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

Acronym

MOM

Official Title

A Randomized Multicentre Clinical Trial Comparing The Metal on Metal Hip System Versus The Metal on Highly Crossed Linked Polyethylene System

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Terminated

Why Stopped

Components were recalled by Depuy

Study Start Date

January 2007 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nova Scotia Health Authority

Collaborators

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial will evaluate the 36mm or greater metal head on metal hip system and compare it to the 32mm or 28mm metal head on polyethylene (liner) hip system in patients receiving a primary cementless total hip replacement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Metal on Metal

Arm Type

Active Comparator

Arm Description

Metal on Metal articulation system

Arm Title

HCLPC

Arm Type

Active Comparator

Arm Description

THA using Highly Cross Linked Polyethylene cup System

Intervention Type

Device

Intervention Name(s)

Metal on Metal Hip System

Other Intervention Name(s)

Depuy ASR

Intervention Description

Total hip arthroplasty with a metal on metal component system

Intervention Type

Device

Intervention Name(s)

Highly Cross Linked Polyethylene cup System

Other Intervention Name(s)

Depuy Pinnacle Cup and Marathon liner

Intervention Description

Total hip arthroplasty with Highly Cross Linked Polyethylene cup System

Primary Outcome Measure Information:

Title

Revision Rate

Time Frame

4 years

Secondary Outcome Measure Information:

Title

Wear and osteolysis

Time Frame

5-15 years

Title

Harris Hip Score

Time Frame

immediate post-op, 6 months, 1 year, 2 years, 4 years

Title

Dislocation Rate

Time Frame

4 years

Title

Complication Rate

Description

All complications

Time Frame

4 years

Title

Gait Analysis

Description

Using the Walkabout portable gait monitor

Time Frame

6 months and 1 year post-op

Title

Metal Ions

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ross K Leighton, MD

Organizational Affiliation

Nova Scotia Health Authority

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

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