Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

Rheumatoid Arthritis Clinical Trial

— MOM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01422564
• Other study ID #: RL 006
• Status: Terminated
• Phase: Phase 4
• First received: August 12, 2011
• Last updated: May 14, 2015
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: March 2014
• Source: Nova Scotia Health Authority
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 41
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• Metal on Metal Hip System
Total hip arthroplasty with a metal on metal component system
• Highly Cross Linked Polyethylene cup System
Total hip arthroplasty with Highly Cross Linked Polyethylene cup System

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Nova Scotia Health Authority	University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Revision Rate		4 years	Yes
Secondary	Wear and osteolysis		5-15 years	No
Secondary	Harris Hip Score		immediate post-op, 6 months, 1 year, 2 years, 4 years	No
Secondary	Dislocation Rate		4 years	Yes
Secondary	Complication Rate	All complications	4 years	No
Secondary	Gait Analysis	Using the Walkabout portable gait monitor	6 months and 1 year post-op	No
Secondary	Metal Ions		4 years	Yes