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

Osteoarthritis of Hip Clinical Trial

Official title:

Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary Total Hip Arthroplasty Using Radiostereometric Analysis (RSA)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00551967
• Other study ID #: 2007P000337
• Status: Active, not recruiting
• Phase: N/A
• First received: October 30, 2007
• Last updated: May 2, 2017
• Start date: October 2007
• Est. completion date: December 2022

Study information

• Verified date: May 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female

• 20 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of Hip
• Osteoarthritis, Hip
• Traumatic Arthritis of Hip

Intervention

Procedure:
• Hip replacement
Surgical implantation of hip replacement components for the treatment of osteoarthritis

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Zimmer Biomet

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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