Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02196792
NCT02196792
Active, Not Recruiting
N/A

Assessment of Polyethylene Wear, Migration and Clinical Outcome in Total Hip Replacement - A Prospective Randomized Control Trial

Odense University Hospital1 site in 1 country100 target enrollmentMay 1, 2009
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsOsteoarthritis, HipOsteoarthritis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Osteoarthritis, Hip
Sponsor
Odense University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Mean head penetration from baseline to 5 year follow-up
Status
Active, Not Recruiting
Last Updated
3 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.

Registry
clinicaltrials.gov
Start Date
May 1, 2009
End Date
May 1, 2030
Last Updated
3 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joseph Abdalla Nommesen El-Sahoury

Research assistant

Odense University Hospital

Eligibility Criteria

Inclusion Criteria

  • •Primary idiopathic arthritis,
  • •Eligible for uncemented total hip arthroplasty
  • •40 to70 years of age,
  • •Cup size of 54mm and above

Exclusion Criteria

  • •Anteversion where non-standard stem can be used,
  • •Dysplasia (Center-edge angle of Wiberg \< 20°),
  • •Malignant condition
  • •Prior radiotherapy
  • •Physical or psychological condition that renders it impossible for the patient to take part in our usual rehabilitation programme (as stated in the department's standard operation procedure),
  • •Complications during surgery (requiring screws in shell or femoral cerclage)

Outcomes

Primary Outcomes

Mean head penetration from baseline to 5 year follow-up

Time Frame: From baseline to 5 years

Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up

Secondary Outcomes

  • Mean cup migration form baseline to 5 year follow-up(From baseline to 5 years)
  • Mean change in clinical outcome score from baseline to 5 year follow-up(From baseline to 5 years)

Study Sites (1)

Loading locations...

Similar Trials

Active, Not Recruiting
N/A
All-poly Versus Metal-backedOsteoarthritis
NCT04358601Region Skane60
Completed
N/A
Migration and Survival of All-polyethylene Tibial All Poly Components Compared to the Metal-backed Modular Components of the Triathlon CS Total Knee System. A Single Center RSA StudyArthritis
NCT04358575Region Skane60
Active, Not Recruiting
Phase 3
All-polyethylene tibia components compared to metal-backed tibia components in total knee replacement.OsteoarthritisMusculoskeletal Diseases
ISRCTN04081530Stryker European Operations BV (Netherlands)60
Active, Not Recruiting
Phase 3
All-polyethylene tibia PS components compared to metal-backed tibia PS components in total knee replacement
ISRCTN10744502Stryker European Operations BV (Netherlands)60
Unknown
N/A
Evaluation of the Wear of Vitamin E Treated Polyethylene Components in Primary THA Using RSAOsteoarthritis of HipTraumatic Arthritis of Hip
NCT00551967Massachusetts General Hospital50