Vitamin E-Diffused Highly Cross-Linked Polyethylene Liner
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
E-poly
ArComXL
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- primary and certain subgroups of secondary osteoarthritis
- Patients aged 20-75 years
Exclusion Criteria:
- inflammatory arthritis
- cortisone or chemotherapy treatment
- known osteoporosis or osteomalacia
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
E-XLPE
C-XLPE
Arm Description
E-poly
ArComXL
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cup and stem translations
Evaluation of cup and stem translations of vitamin E incorporated highly cross linked polyethylene compared to annealed polyethylene liner ArComXL liner.
Full Information
NCT ID
NCT02801019
First Posted
April 30, 2014
Last Updated
June 9, 2016
Sponsor
Sahlgrenska University Hospital, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT02801019
Brief Title
Vitamin E-Diffused Highly Cross-Linked Polyethylene Liner
Official Title
Wear and Creep of Vitamin E-Diffused Highly Cross-Linked Polyethylene Liners Randomized Radiostereometric Study of 70 Hips Followed for 2 Years
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sahlgrenska University Hospital, Sweden
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
First generation of modern highly cross-linked polyethylene (XLPE) was clinically introduced in 1998 and has in most countries become standard as bearing surface in total hip arthroplasty. Studies of these materials have shown significantly reduced femoral head penetration when compared to gamma sterilized conventional polyethylene.
Thermaly treating (melting or annealing) is often a part of the manufacturing process of highly cross-linked polyethylenes. The polyethylene is exposed to irradiation to achieve cross-linking and improve wear resistance. Cross-linking by irradiation increases the amount of free radicals in the material.These radicals must be eliminated or stabilized to avoid oxidative degradation over time.Thermal treatment improves oxidation resistance but potentially changes the mechanical properties of the polyethylene.
By annealing i.e. heat treatment under the melt temperature the material maintains better mechanical properties, but elimination of free radicals is suboptimal, which can lead to oxidation in vivo.Heat treatment of the polyethylene above the melt temperature will more effectively reduce or eliminate the amount of residual free radicals. This will increase oxidation resistance, but will negatively influence the mechanical properties of the material.
Due to these limitations new generations of cross-linked polyethylene materials have been developed. Introducing Vitamin E (α-tocopherol), a natural antioxidant into the material prevents oxidative degradation and stabilizes the free radicals found in irradiated polyethylene plastic. In laboratory tests, polyethylene liners with incorporated vitamin-E have demonstrated similar wear, greater strength and better resistance to oxidation compared with the first generation cross-linked polyethylene. Currently, there are only laboratory studies on vitamin E diffused polyethylene available.
The hypothesis in this study is that the early-term E-XLPE wear is low and comparable to a heat-treated XLPE. The investigators also hypothesize that implant fixation and clinical outcome at two years will be unaffected by the choice of polyethylene.
The investigators therefore evaluated the early bedding in and wear in an uncemented arthroplasty supplied with liners made of vitamin E diffusion doped XLPE (E1®, Biomet, Warsaw, IN, USA). In the control group the investigators used the same uncemented hip prosthesis with polyethylene liners manufactured to achieve high levels of crosslinking without sacrificing the mechanical strength and extinguish residual free radicals (ArComXL® , Biomet, Warzaw, IN, USA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E-XLPE
Arm Type
Experimental
Arm Description
E-poly
Arm Title
C-XLPE
Arm Type
Active Comparator
Arm Description
ArComXL
Intervention Type
Other
Intervention Name(s)
E-poly
Intervention Description
comparison of two different polyethylene plastic 0,04 mm at 3 months 0,06 at 2 years
Intervention Type
Other
Intervention Name(s)
ArComXL
Intervention Description
comparison of two different polyethylene plastic 0,03 mm at 3 months 0,10 mm at 2 years
Primary Outcome Measure Information:
Title
Wear of vitamin E incorporated highly cross linked polyethylene
Description
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.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
Cup and stem translations
Description
Evaluation of cup and stem translations of vitamin E incorporated highly cross linked polyethylene compared to annealed polyethylene liner ArComXL liner.
Time Frame
up to 2 years
Other Pre-specified Outcome Measures:
Title
Precision of the Radiostereometric analysis method
Description
The differences between the postoperative double-examinations was used to compute the precision for the method.
Time Frame
Postoperatively, whitin 3 to 5 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
primary and certain subgroups of secondary osteoarthritis
Patients aged 20-75 years
Exclusion Criteria:
inflammatory arthritis
cortisone or chemotherapy treatment
known osteoporosis or osteomalacia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Kärrholm, Professor
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vitamin E-Diffused Highly Cross-Linked Polyethylene Liner
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