Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02254980
• Date of registration: 30/09/2014
• Prospective Registration: No
• Primary sponsor: Danderyd Hospital
• Public title: Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup in Total Hip Arthroplasty E1-hip
• Scientific title: Migration and Head Penetration of Vitamin-E Diffused Cemented Polyethylene Cup Compared to Standard Cemented Cup in Total Hip Arthroplasty. A Randomized, Single-blinded, Clinical Trial
• Date of first enrolment: February 2013
• Target sample size: 44
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02254980
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Primary osteoarthritis of the hip

- Willingness and ability to follow study-protocol

Exclusion Criteria:

- Inflammatory arthritis or secondary osteoarthritis.

- Type C (stove pipe) femur

- Abnormal femoral or pelvic anatomy after hip dysplasia, not suitable for implantation
of components

- Treatment with bisphosphonates, cortisol or cytostatic drugs 6 months prior to surgery

- Ongoing oestrogen treatment

- Not suited for the study for other reason (surgeons preference)



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Total Hip Arthroplasty

Intervention(s)

Device: Standard polyethylene acetabular component

Device: Vitamin-E diffused polyethylene acetabular component

Primary Outcome(s)

Cup migration [Time Frame: 2 years]

Secondary Outcome(s)

Complication rate [Time Frame: 10 years]

Cup migration total [Time Frame: 2 years]

Functional outcome [Time Frame: 2 years]

Linear wear [Time Frame: 2 years]

Osteolysis [Time Frame: 2 years]

Linear wear [Time Frame: 4 years]

Osteolysis [Time Frame: 10 years]

Secondary ID(s)

E1-H

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zimmer Biomet