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Randomized Controlled Trial
. 2020 Dec;49(12):1077-1085.
doi: 10.1007/s00132-019-03830-6.

Vitamin E-blended versus conventional polyethylene liners in prostheses : Prospective, randomized trial with 3-year follow-up

André Busch  1 , Marcus Jäger  2 ; VITAS group; Alexander Wegner  2 , Marcel Haversath  2
Collaborators, Affiliations
Randomized Controlled Trial

Vitamin E-blended versus conventional polyethylene liners in prostheses : Prospective, randomized trial with 3-year follow-up

André Busch et al. Orthopade. 2020 Dec.

Abstract

Background: Despite continuous technical improvements, polyethylene wear debris induced periprosthetic osteolysis remains the main cause for failure of hip arthroplasty. Progressive oxidation of polyethylene was identified as another risk factor for material failure. To overcome this problem, antioxidants such as vitamin E (alpha-tocopherol) were supplemented by diffusion into the latest generation of polyethylene liners.

Objective: The purpose of the present study was to investigate the clinical outcome of patients treated with vitamin E blended highly cross-linked ultra-high molecular weight polyethylene liners (UHMWPE-XE) in comparison with conventional UHMWPE‑X liners by evaluating patient-reported outcome measures (PROM's) at 3‑year follow-up.

Methods: A total of 143 patients were recruited into this prospective, randomized trial in our academic center. Three years after implantation, 101 patients were examined in the outpatient clinic for follow-up. Of these, 51 (50.5%) received UHMWPE-XE and 50 (49.5%) UHMWPE‑X liners. Clinical outcome was evaluated using Harris-Hip-Score (HHS) UCLA-Score and Hip Disability and Osteoarthritis Outcome Score (HOOS).

Results: There was a significant improvement in all PROM's at one- and three-year follow-up compared to the status before implantation. PROM's did not differ significantly between the first and third year follow-up. Both liner groups showed an equal clinical outcome.

Conclusion: The present study demonstrates that the supplementation of vitamin E to polyethylene liners is reliable and safe without showing higher complication rates compared with conventional polyethylene liners. The shortterm clinical outcome of vitamin E-blended (UHMWPE‑XE) is equivalent to those of conventional highly cross-linked polyethylene liners.

Keywords: Antioxidant; Biomaterials; Patient-related outcome measurement; Prosthesis durability; Total hip replacement.

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