Metal on Metal Versus Metal on Highly Crossed Linked Polyethylene Sytem

NCT01422564 | Terminated Phase 4

• 1 other identifier: RL 006
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Revision Rate

  4 years

Secondary Outcomes (6)

• Wear and osteolysis

  5-15 years

• Harris Hip Score

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

• Dislocation Rate

  4 years

• Complication Rate

  4 years

• Gait Analysis

  6 months and 1 year post-op

Study Arms (2)

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

Metal on Metal Hip System DEVICE

Total hip arthroplasty with a metal on metal component system

Also known as: Depuy ASR

Metal on Metal

Highly Cross Linked Polyethylene cup System DEVICE

Total hip arthroplasty with Highly Cross Linked Polyethylene cup System

Also known as: Depuy Pinnacle Cup and Marathon liner

HCLPC

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead
• University Health Network, Toronto: collaborator

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid; Hip Dislocation, Congenital; Spondylitis, Ankylosing; Hip Injuries

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Developmental Dysplasia of the Hip; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Ankylosis; Wounds and Injuries

Study Officials

• Ross K Leighton, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 24, 2011
• Study Start: January 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 15, 2015

Record last verified: 2014-03