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

Nova Scotia Health Authority (NSHA)

Status and phase

Terminated

Phase 4

Conditions

Congenital Dysplasia of the Hip

Osteoarthritis

Post-traumatic; Arthrosis

Injury of Hip and Thigh

Avascular Necrosis

Ankylosing Spondylitis

Rheumatoid Arthritis

Treatments

Device: Metal on Metal Hip System

Device: Highly Cross Linked Polyethylene cup System

Study type

Interventional

Funder types

Other

Identifiers

NCT01422564

RL 006

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

65+ years old

Volunteers

No 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.