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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 76 - 76
1 May 2017
De Pasquale D Beraudi A 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 Region Emilia Romagna, Italy, 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 /litre).

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

Level of Evidence

III retrospective, comparative study

Acknowledgments

The research was funded by Ministry of Health, grant ‘Early diagnosis of pending failure…’RF 20091472961


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 66 - 66
1 Jan 2017
Baruffaldi F Mecca R Stea S Beraudi A Bordini B Amabile M Sudanese A Toni A
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Ceramic-on-ceramic (CoC) total hip arthroplasty (THA) can produce articular noise during the normal activities, generating discomfort to the patient. THA noise has to be investigated also as a potential predictor and a clinical sign of prosthetic failure.

An observational study has been carried out to characterize the noise in CoC cementless THA, and to analyze the related factors. A total of 46 patients with noisy hip have been enrolled in 38 months, within the follow-up protocol normally applied for the early diagnosis of ceramic liner fracture [1]. Noise recording was based on a high-quality audible recorder (mod. LS 3, Olympus, Japan) and a portable ultrasonic transducer (mod USB AE 1ch, PAC, USA). The sensors for noise recording were applied to the hip of the patient during a sequence of repeatable motorial activities (forward and backward walking, squat, sit in a chair, flexion and extension of the leg). Sessions were also video-recorded to associate the noise emission to the specific movements.

Each noise event was initially identified by the operator and therefore classified by comparison to the spectral characteristics (duration, intensity and frequency) of the main noise types. Number and spectral characteristics of noise events were obtained and correlated to the factors describing the clinical status of the patient, the surgical approach, the prosthetic device implanted. The study investigated also the noise as a sign of implant failure, by comparison with the total number of implants failed in the cohort during the study.

We observed three types of noise with the main spectral characteristics in agreement to the literature: clicking, squeaking and popping. Among the identified types of noise, squeaking showed the longest duration and the highest amplitude. The 63% of hip presented the emission of just one type of noise, while the remaining a mix of types. The movement with the highest presence of noise was walking, followed by squat. Correlation was found between the noise type and the dimension of the ceramic head (p<0.001), with the sizes of 32 mm more affected by squeaking that the smaller one. Squeaking appeared before during the follow-up than the other types of noise. The 35% (16/46) of the noisy hips were revised during the study. Among the revised hips, the 81% (13/16) were affected by impingement and/or severe damage of the prosthetic components. The antiversion of the cup (p=0.008), the presence of debris in the synovial fluid (p=0.021) and the average frequency of squeaking (p=0.006) were significant predictors for the revision, but it has to be mentioned that the squeaking data was obtained on a small subset of revised patients. Ultrasonic analysis did not show significant correlations.

The study presented and validated an experimental procedure to analyze noisy hips in clinical trials. Noise is confirmed to be a significant parameter in the follow-up evaluation of ceramic THA.


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.


Orthopaedic Proceedings
Vol. 87-B, Issue SUPP_I | Pages 63 - 63
1 Mar 2005
Antonietti B Stea S Baruffaldi F Visentin M Bordini B Sudanese A Toni A
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Aim: Polyethylene used for Total Hip Artrhroplasty components can be sterilized with different methods. Among them there is gamma rays. This method is currently used for conventional polyethylene and has been used also for Hylamer, a high cristallinity polyethylene manufactured by Depuy in early nineties. Recently Hylamer polyethylene components gamma sterilized in air were ‘recalled’ by Health Authorities, due to excessive wear. Aim of the present study was to evaluate radiographic and clinical performance of Hylamer acetabular liners gamma sterilized in air, and compare them to same devices gamma sterilized in nitrogen atmosphere.

Methods: Thirty-one patients “gamma in air” were matched to thirty controls with the same implanted socket but with the insert sterilized in a nitrogen atmosphere in a retrospective matched case-control. Moreover, a second control group was matched from twenty-three patients with a different prosthesis (ABG cup, Stryker-Howmedica) but with a similar insert made by conventional polyethylene gamma sterilized in absence of oxygen. Clinical evaluation was made according to the Harris Hip-scoring system. Radiographic wear measurements and osteolytic lesion was performed comparing the post-operative pelvic radiograph with the last follow-up study.

Results: Among 3 groups there was no significant difference in the clinical performance. At a mean of seven years, we found a significant difference between the mean rate of wear and osteolytic lesion of Hylamer sterilized in air and Hylamer sterilized in a nitrogen atmosphere.

Conclusion: We concluded that the manufacturing and sterilization processes influence the resistance to oxidation and wear of the various types of ultra-high molecular polyethylene that are currently available.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 378 - 378
1 Mar 2004
Toni A Traina F Stea S Guerra E Giunti A
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Aims: The aim of this retrospective study is comparatively analysing cemented versus hydroxyapatite coated cementless þxation. A 10-year survival analysis of 2 patient cohorts operated by the same senior surgeons and with the same stem design was performed. Methods: Between 1990 and 2000, 1207 primary prostheses, 599 cemented and 608 cementless stems have been implanted. When mineral bone density and anatomic shape of the femur advised against inserting a cement-less stem a third generation cementing technique was chosen. In all cases an anatomic CoCr alloy stem and an alumina coupling were employed. Cementless stems were fully coated with hydroxyapatite. To provide homogeneity for preoperative diagnosis, only replacements for primary arthritis were considered. The remaining prostheses were 432 cemented and 366 cementless. The cumulative probability of revision for aseptic loosening of the stem was estimated by the Kaplan-Meier method. Results: 98.5% of the cemented stems and 96.7% of the cementless stems survived at 10 years, the difference between the 2 cohorts being statistically not signiþcant (p> 0.05). Conclusions: Using the same stem design and ceramic coupling, thus avoiding the confounding presence of polyethylene wears debris on study outcomes, allows for the reliable evaluation of stem þxation effectiveness. Noting that the evaluated survival rates are consistent with the literature, we are conþdent that at 10 years cementless stems performed as cemented.


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 5 | Pages 912 - 917
1 Sep 1998
Granchi D Verri E Ciapetti G Stea S Savarino L Sudanese A Mieti M Rotini R Dallari D Zinghi G Montanaro L

Our aim was to determine if the serum levels of bone-resorbing cytokines (IL-1β, TNF-α, IL-6, GM-CSF) are altered in patients with aseptic loosening of a total hip prosthesis, and if such levels are influenced by the type of implant. We determined cytokine levels in sera from 35 patients before revision for failed total hip arthroplasty and compared them with those in 25 healthy donors. We also assessed the soluble receptor of interleukin-2 (sIL-2r) in serum as an indication of a specific immune reaction against the implant.

Our findings showed that the sIL-2r and TNF-α serum level did not change. The IL-6 level was not significantly altered, but was higher in patients with TiAlV prostheses than in those with a CrCoMo implant and in patients with cemented prostheses. The IL-1β level was found to be higher in those with a TiAlV cemented prosthesis than in the control group (p = 0.0001) and other groups of patients (p = 0.003 v uncemented TiAlV, p = 0.01 v cemented CrCoMo, p = 0.001 v uncemented CrCoMo). The GM-CSF level significantly increased in patients compared with healthy subjects (p = 0.008), and it was higher in those with cemented than with uncemented implants (p = 0.01). Only patients with cementless CrCoMo prostheses had levels of GM-CSF similar to those of the control group. The highest GM-CSF concentrations were observed in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs) in the last months before revision (p = 0.04). In addition, when massive osteolysis was observed, the level of GM-CSF tended to decrease to that of the control group.