Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

Phase 4

Terminated

• Conditions: Rheumatoid Arthritis; Osteoarthritis; Avascular Necrosis; Congenital Dysplasia of the Hip; Ankylosing Spondylitis; Post-traumatic; Arthrosis; Injury of Hip and Thigh
• Interventions: Device: Highly Cross Linked Polyethylene cup System; Device: Metal on Metal Hip System

• Registration Number: NCT01422564
• Lead Sponsor: Nova Scotia Health Authority

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2011-08-12
• Study First Submitted QC: 2011-08-23
• Study First Posted: 2011-08-24
• Status Verified: 2014-03
• Last Update Submitted: 2015-05-14
• Last Update Posted: 2015-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCLPC	Highly Cross Linked Polyethylene cup System	THA using Highly Cross Linked Polyethylene cup System
Metal on Metal	Metal on Metal Hip System	Metal on Metal articulation system

Primary Outcome Measures

Name	Time	Method
Revision Rate	4 years

Secondary Outcome Measures

Name	Time	Method
Wear and osteolysis	5-15 years
Harris Hip Score	immediate post-op, 6 months, 1 year, 2 years, 4 years
Dislocation Rate	4 years
Metal Ions	4 years
Complication Rate	4 years	All complications
Gait Analysis	6 months and 1 year post-op	Using the Walkabout portable gait monitor