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Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 39 - 39
1 May 2016
Stea S Bordini B Ancarani C Beraudi A Caputo D Toni A
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The RIPO register collects data of all primary and revision hip replacement surgeries performed in Region Emilia-Romagna, Italy since 1stJanuary 2000.

The present study is aimed to analyze the survival rate of patients with Biolox®delta and Biolox®forte components, (CeramTec, Plochingen Germany) considering possible confounding factors. Only patients living in the region are considered in analysis, to avoid the bias resulting from the ‘loss’ of non-resident patients. The analysis has been conducted only on uncemented THA and monoblock, double mobility cups as well as such with pre-assembled inserts were excluded. Therefore, the finally analyzed database consists of 30’617 cases; 13’323 Biolox®forte and 17’294 Biolox®delta heads, articulating against ceramic or PE.

Unadjusted survival analysis was calculated according to Kaplan Meier method; with prosthesis failure as end point, defined as the revision of any prosthetic component for any cause.

To avoid a possible bias, revision of the prosthesis due to breakage of modular necks of the stem have not been considered. The results are summarized in Table 1.

*survival at 6 yrs follow-up

After adjusting for age and gender it resulted that Biolox®delta - XLpoly and Biolox®forte – poly increase the risk of revision (HR 1.4 and 1.2) compared to Biolox®delta - Biolox®delta;

When only ceramic fractures are considered, we observed 1 fracture of a 36 mm Delta head (1/8’917 = 0.01%) and 38 fractures of 28 mm Forte heads. The 38 fractures occurred mainly in cer-cer coupling (35/3’537 implants= 1%) and occasionally in cer-poly couplings (3/4’246 implants = 0.07%).

Fracture or damage of the Biolox®delta insert occurred in 10 implants out of 14’260(0.07%), while it had a higher incidence in Forte inserts (36 casesout of 6’932 implants = 0.52%).

It can be concluded that the presence of a poly liner decrease the survival of the implant. Beside this Biolox®delta significantly improved the resistance to fracture of both head and insert.

Acknowledgements

This work was partially supported by Italian Ministry of Health, Grant ‘Early diagnosis of pending failure.’ and by Regione Emilia Romagna, cofounding of RIPO. All orthopedic Units of the Region are gratefully acknowledged for providing data to the Register


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_7 | Pages 38 - 38
1 May 2016
Beraudi A Pasquale D Stea S Baleani M Guerra G Toni A
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Modular femoral stems for total hip arthroplasty (THA) were introduced to allow additional options for surgeons in controlling leg lengths, offset and implant stability. This option is widely used in our Region, where the study was conducted, having a modular neck stem nearly 35% of primary THA in 2013. Great majority of modular neck is made of Titanium alloy.

The study was designed as a retrospective descriptive case series of 67 hips in patients who underwent revision of a THA. All had a Titanium modular neck. In 44 cases revision was due to breakage of the neck, in the remaining 23 it was due to different reasons unrelated to modular neck such as bone fracture, breakage of a ceramic component, cup loosening.

Mean follow up was 3.5 yrs. For all patients excised capsule and surrounding tissue were graded for presence of necrosis, inflammatory exudate, lymphocytes, and wear particles using light microscopy of routine paraffin sections stained with hematoxylin and eosin. The retrieved modular neck-body and head-neck junctions were examined for evidence of fretting and corrosion. For some patient dosage of circulating Titanium was obtained. Approval was obtained from institutional review board.

It resulted that a variable amount of wear was observed in the first group of patients, with no evidence of lymphocytic reaction, but with variable notes of necrosis. Broken necks showed different patterns of damage, with different degree of corrosion, beside the fatigue fracture. In the second group wear was less evident or absent and negativity of lymphocyte reaction was substantially confirmed. Circulating Titanium ions were one order of magnitude higher in first group (mean 35 micrograms /liter).

It can be concluded that fracture of Titanium modular necks occurs progressively, wear does not induce lymphocytic reaction and circulating ions increase.


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_2 | Pages 1 - 1
1 Jan 2016
Giardina F Guerra G Stea S Bordini B Sudanese A Toni A
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After a few years from its introduction, the limits of the THA became evident, mainly due to high rates of mobilization for polyethylene wear and to the release of metal ions from MOM and MOP couplings.

Ceramic bearings were thus introduced in surgery to obtain lower levels of friction and wear.

These issues have now been well recognized by several studies, which show that ceramic-on-ceramic joint has the lowest wear rate among various articulations and that ceramic particles induce less macrophage reaction and decrease cytokine secretion, allowing to have little periprosthetic osteolysis.

After the first results in the late 70′s and early 80′s, the mechanical reliability was improved due to the manufacturers' efforts to reduce the ceramic fragility evolving average grain microstructure and lowering the degree of impurity.

Betterment and standardization of production have led to 3rd generation alumina, Biolox Forte in 1994, that achieved a lower incidence of fracture.

The purpose of our study has been to assess long-term follow-up results of alumina-on-alumina 3rd generation ceramic total hip cementless arthroplasty performed at our institution from January 1995 to December 2000.

We prospectively followed more than 200 patients operated of THA for primary or secondary hip osteoarthritis analyzing clinical and radiographs features.

In this period, the total hip replacement were performed by a single surgeon, who is the senior author (A.T.) in our Institution.

All patients were clinically examined to confirm the diagnosis and all of them were checked with a standard plain radiographs in two projections and, when necessary, the radiographic examination was completed by CT scans.

The same prosthesis was used in all patients, a 3rd generation alumina COC articulation, composed of a hemispherical titanium alloy cup and a 28-mm alumina ceramic femoral head. The modular ceramic head was fixed to a 12/14 taper cone.

Proximally plasma-spray hydroxyapatite coated Ti alloy stems completes the implant features. Modular necks were used in retro or anteversion and varus or valgus offset, allowing changes in neck-shaft angle and giving a perfect intraoperative stability.

Clinical assessment was performed using the Merle-D'Aubigne and Postel hip score. Each patient was assessed before surgery, after 30 days, afterwards at 4 months and annually after surgery.

The mode of femoral component fixation was radiographically classified as bone ingrowth fixation, stable fibrous fixation or unstable fixation, according to the criteria Engh-Bobyn.

Osteolysis was evaluated on the femoral side at each Gruen zone. Osteolysis on the acetabular side was evaluated by DeLee and Chanley zone.

Our study has concluded that cementless modular hip arthroplasty with 3rd generation ceramic-on-ceramic bearing, with a 13 to 18 years follow-up, shows an excellent survivorship, in particular for the very low volume release of microparticles during friction, which consequently reduction of cytokine release, thus diminishing the risk of periprosthetic osteolysis and loosening of implant components.