Metal Ion Release From an FDA-Approved Metal-on-Metal Total Hip Replacement Implant

Non-inflammatory Degenerative Joint Disease Clinical Trial

Official title:

Metal Ion Release From an FDA Approved Metal-on-Metal Hip Replacement Implant: A Multi-Center, Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962351
• Other study ID #: AORI2009-0100
• Status: Completed
• Phase: N/A
• First received: August 19, 2009
• Last updated: August 14, 2015
• Start date: October 2003
• Est. completion date: October 2013

Study information

• Verified date: August 2015
• Source: Anderson Orthopaedic Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a multi-center, randomized study to compare blood and urine cobalt, chromium, and titanium ion levels of a metal-on-metal articular bearing coupled with two different head sizes to that of a conventional metal-on-polyethylene bearing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2013
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• Undergoing cementless primary total hip replacement

• Receiving acetabular cup of 52mm or greater

• Preoperative level of function and pain same as for conventional hip replacement

• Likelihood of obtaining relief of pain and improved function

• Full skeletal maturity

• Ability to follow instructions

• Good general health

• Willing to return for follow-up evaluations

• X-ray evaluation confirming the presence of NIDJD

• Femoral and acetabular bone stock that is sufficient, regarding strength and shape, and suitable to receive the implants

Exclusion Criteria:

• Age less than 40 years or greater than 80 years at time of surgery

• Patients templated to receive an acetabular component smaller than 52mm in diameter

• Presence of a previous prosthetic hip replacement device in the hip joint to be operated

• Previous girdlestone procedure or surgical fusion of the hip to be operated

• Acute femoral neck fracture

• Above knee amputation of the contralateral and/or ipsilateral leg

• Patients with a diagnosis of inflammatory degenerative arthritis

• Skeletally immature

• Evidence of active infections that may spread to other areas of the body

• The presence of a highly communicable disease that may limit follow-up

• Presence of known active metastatic or neoplastic disease

• Significant neurologic or musculoskeletal disorders or disease that may adversely affect gait or weightbearing

• Any previous hip surgery or conditions that may interfere with the total hip replacement's survival or outcome

• Any patient believed to be unwilling or unable to comply with a rehabilitation program for a cementless total hip replacement or indicates difficulty to return for follow-up

• Patient is know to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser

• Any patient who qualifies for inclusion in the study but refuses consent to participate in the study

• Any steroid therapy, local or systemic, within three months prior to surgery

• Patient requiring structural bone grafts in order to support the prosthetic components or to shape the bone to receive the implants

• Patient has known allergies to metal, e.g., jewelry

• Any patient not meeting all radiographic and clinical parameters for inclusion

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Non-inflammatory Degenerative Joint Disease
• Osteoarthritis

Intervention

Procedure:
• Total Hip Replacement

Locations

Country	Name	City	State
Canada	Department of Orthopaedic Surgery, University of Western Ontario	London	Ontario
United States	Anderson Orthopaedic Research Institute	Alexandria	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Anderson Orthopaedic Research Institute	DePuy Orthopaedics, University of Western Ontario, Canada

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Engh CA Jr, MacDonald SJ, Sritulanondha S, Thompson A, Naudie D, Engh CA. 2008 John Charnley award: metal ion levels after metal-on-metal total hip arthroplasty: a randomized trial. Clin Orthop Relat Res. 2009 Jan;467(1):101-11. doi: 10.1007/s11999-008-05 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cobalt, chromium, and titanium ion levels in blood and urine		Pre-op, 6 months, 1 year, 2 years, 3 years, 5 years	No
Secondary	Hip function		Pre-op, 6 months,1 year, 2 years, 3 years, 5 years	No
Secondary	Durability		6 months, 1 year, 2 years, 3 years, 5 years	No