Abstract
Polyimide (MP-1, MMATech, Haifa, Israel), is a high performance aerospace thermoplastic used for its lubricity, stability, inertness and radiation resistance. A wear resistant thin robust bearing is needed for total hip arthroplasty (THR).
After independent laboratory testing, in 2006, the author used the material as a bearing in two Reflection (Smith and Nephew, USA) hip surgeries. The first, a revision for polyethylene wear, survives with no evidence of wear, noise, new osteolysis or complications related to the MP-1 bearing after 16 yrs. The second donated his asymptomatic MP-1 hip at 6.5yrs for post-mortem examination. There were no osteoclasts, cellular reaction bland in contrast to that of polyethylene.
In 2013 a clinical study with ethical committee approval was started using a Biolox Delta (Ceramtec, Germany) head against a polyimide liner in 97 patients. MMATech sold all liners, irradiated: steam 52:45. Sixteen were re-machined in New Zealand. Acetabular shells were Delta PF (LIMA, Italy). The liner locked by taper.
The cohort consisted of 46:51 M:F, and ages 43 to 85, mean 65. Ten received cemented stems. For contralateral surgery, a ceramic or polyethylene liner was used. Initial patients were lower demand, later, more active patients, mountain-biking and running.
All patients have on-going follow up, including MP-1 liner revision cases. There has been no measurable wear, or osteolysis around the acetabular components using weight-bearing radiographs. Squeaking within the first 6 weeks was noted in 39 number of cases and subtle increase in palpable friction, (passive rotation at 50 degrees flexion), but then disappeared. There were 6 revisions, four of which were related to cementless Stemsys implants (Evolutis, Italy) fixed distally with proximal linear lucencies in Gruen zones 1 and 7, and 2 and 6. No shells were revised and MP-1 liners were routinely changed to ceramic or polyethylene. The liners showed no head contact at the apex, with highly polished contact areas.
There were no deep or superficial infections, but one traumatic anterior dislocation at 7 years associated with 5 mm subsidence of a non-collared stem.
The initial squeaking and increased friction was due to the engineering of the liner / shell composite as implanted, not allowing adequate clearance for fluid film lubrication and contributed to by shell distortion during impaction. The revised bearings were “equatorial” rather than polar, and with lack of wear or creep this never fully resolved. Where the clearance was better, function was normal. The “slow” utilization was due to my ongoing concern with clearances not being correct. The revision of 4 Stemsys stems, tribology issues may have contributed, but non “MP-1” / Stemsys combinations outside this study have shown the same response, thought to be due to de-bonding of the hydroxyapatite coating.
With correct engineering and clearances, a 3.6 mm thick MP-1 bearing, a surface Ra<0.5, steam sterilized, shows no appreciable wear, and with confidence, can be used as a high performance THR bearing.
