Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSA

NCT00551967 | Unknown

• 1 other identifier: 2007P000337
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this proposed study is to conduct a prospective RSA clinical study at Massachusetts General Hospital involving 50 patients receiving primary total hip replacements. All patients will receive the vitamin E treated polyethylene acetabular inserts. Short-term femoral head penetration and long-term steady state wear of the polyethylene will be measured using both RSA and Martell analysis techniques. Stability of the acetabular and femoral components will be measured in all patients using RSA analysis. The stability of the cemented femoral stems will be compared to the stability of the cementless femoral components as well as to historic data in the literature. In addition, all patients will complete a self-administered questionnaire to assess the clinical outcome of the surgery and patient satisfaction.

Conditions

Osteoarthritis of Hip; Traumatic Arthritis of Hip

Keywords

clinical outcomes; radiographic outcomes; total hip arthroplasty; survivorship

Outcome Measures

Primary Outcomes (1)

• Short-term femoral head penetration,long-term steady state wear of polyethylene. Stability of acetabular & femoral components. Clinical questionnaires to assess preop,clinical outcomes,& patient satisfaction.

  5 years

Study Arms (1)

E1 polyethylene

ACTIVE COMPARATOR

All patients received an E1 polyethylene liner which is the material being monitored in this study.

Procedure: Hip replacement

Interventions

Hip replacement PROCEDURE

Surgical implantation of hip replacement components for the treatment of osteoarthritis

E1 polyethylene

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• to 75 years of age
• Subjects requiring primary total hip replacement
• Subjects with diagnosis of osteoarthritis, avascular necrosis, or traumatic arthritis
• Subjects who demonstrate the ability to return to MGH for follow-up for the next five years.

You may not qualify if:

• Subjects with limited life span
• Subjects with difficulty in comprehending study protocol for any reason.
• Subjects with inflammatory disease, previous infection or those requiring revision hip surgery.
• Subjects whose bony structures are so small that a femoral head less than 32mm in diameter must be used.
• Subjects whose bony structure deviates substantially from the general norm sufficiently to require non-standard techniques and non-standard implants. Specific examples of these are total dislocation of the hip, severe coxa vera deformity, severe forms of multiple epiphyseal dysplasia
• Subjects with complex disease entities which significantly increase the risks of the surgery such as any major platelet abnormality, hematological disorder, positive for HIV or any other major medical complication which substantially reduces longevity.
• Female subjects that are pregnant or who may suspect they are pregnant or who plan to become pregnant while participating in this study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Zimmer Biomet: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Henrik Malchau, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: October 30, 2007
• First Posted: November 1, 2007
• Study Start: October 1, 2007
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 3, 2017

Record last verified: 2017-05

Locations

US (1)