NCT02801019

Brief Summary

Vitamin E incorporated highly cross linked polyethylene (E-XLPE) was developed to increase oxidative resistance of highly cross-linked polyethylene (XLPE) without affecting mechanical properties. The investigators evaluated this type of polyethylene in a randomized clinical study, using Radiostereometric Analysis (RSA). The objective of this study was to compare the early-term wear of E-XLPE to a compression annealed polyethylene liner (C-XLPE, ArComXL®). The clinical outcome at two years was not expected to be affected by the choice of polyethylene.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 15, 2016

Status Verified

June 1, 2016

Enrollment Period

3.4 years

First QC Date

April 30, 2014

Last Update Submit

June 9, 2016

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Wear of vitamin E incorporated highly cross linked polyethylene

    Evaluation of the early bedding in and wear in an uncemented arthroplasty supplied with liners made of vitamin E diffusion doped XLPE in comparsion to annealed polyethylene liner, ArComXL.

    up to 2 years

Secondary Outcomes (1)

  • Cup and stem translations

    up to 2 years

Other Outcomes (1)

  • Precision of the Radiostereometric analysis method

    Postoperatively, whitin 3 to 5 days after surgery

Study Arms (2)

E-XLPE

EXPERIMENTAL

E-poly

Other: E-polyOther: ArComXL

C-XLPE

ACTIVE COMPARATOR

ArComXL

Other: E-polyOther: ArComXL

Interventions

E-polyOTHER

comparison of two different polyethylene plastic 0,04 mm at 3 months 0,06 at 2 years

C-XLPEE-XLPE
ArComXLOTHER

comparison of two different polyethylene plastic 0,03 mm at 3 months 0,10 mm at 2 years

C-XLPEE-XLPE

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary and certain subgroups of secondary osteoarthritis
  • Patients aged 20-75 years

You may not qualify if:

  • inflammatory arthritis
  • cortisone or chemotherapy treatment
  • known osteoporosis or osteomalacia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Johan Kärrholm, Professor

    Sahlgrenska University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

April 30, 2014

First Posted

June 15, 2016

Study Start

June 1, 2008

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

June 15, 2016

Record last verified: 2016-06