We present minimum 20 year results of a randomized, prospective double blinded trial (RCT) of cross-linked versus conventional polyethylene (PE), using a computer assisted method of PE wear measurement. After Ethics Committee approval, 122 patients were enrolled into an RCT comparing Enduron (non cross-linked PE) and highly cross-linked Marathon PE (DePuy, Leeds, UK). Other than the PE liners, identical components were used, a Duraloc 300 metal shell with one screw, a 28mm CoCr femoral head and a cemented Charnley Elite femoral stem. All patients were followed with anteroposterior (A∼P) and lateral radiographs at 3 days, 6 weeks, 3 months, 6 months, 1, 2, 3, 4, 5, 10 and 20 years. PE wear was measured with PolyMig, which has a phantom validated accuracy of ± 0.09mm. At minimum 20 year follow-up, 47 patients had died, 5 of which had been revised prior to their death. Another 32 patients were revised and alive, leaving 43 patients unrevised and alive (15 Enduron, 28 Marathon). No patients were lost to follow-up, but 2 were not able to be radiographed (dementia), leaving 41 patients (15 Enduron, 26 Marathon) available for PE wear measurement. After the bedding-in period, Enduron liners had a wear rate of 0.182 mm/year, and Marathon liners had a wear rate of 0.028 mm/year. At 20 years follow-up, 37 patients had required revision. Patients with conventional PE had three times the revision rate (28/37) of those who received XLPE (9/37). This is the longest term RCT showing substantially improved clinical and radiological results when XLPE is used as the bearing surface.
This paper describes the methodology, validation and reliability
of a new computer-assisted method which uses models of the patient’s
bones and the components to measure their migration and polyethylene
wear from radiographs after total hip arthroplasty (THA). Models of the patient’s acetabular and femoral component obtained
from the manufacturer and models of the patient’s pelvis and femur
built from a single computed tomography (CT) scan, are used by a
computer program to measure the migration of the components and
the penetration of the femoral head from anteroposterior and lateral radiographs
taken at follow-up visits. The program simulates the radiographic
setup and matches the position and orientation of the models to
outlines of the pelvis, the acetabular and femoral component, and
femur on radiographs. Changes in position and orientation reflect
the migration of the components and the penetration of the femoral
head. Validation was performed using radiographs of phantoms simulating
known migration and penetration, and the clinical feasibility of
measuring migration was assessed in two patients.Aims
Materials and Methods