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Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_IV | Pages 513 - 513
1 Oct 2010
Dantonio E Piciocco P Santori F Termine
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Introduction: One of the problems of total hip arthroplasty (THA) is blood loss frequently leading to one or more postoperative blood transfusions. The use of fibrin sealants (Quixil) has already proved to be extremely effective in general surgery. Previous reports have shown remarkable benefits in liver resections, soft tissue tumor resections, adenoidectomy and tonsillectomy. The use of these sealants has been recently extended to total hip and total knee replacement surgey. We present our experience with Quixil in our orthopaedic practice.

Materials and Methods:Seventy-eight patients operated for primary THA between June 2006 and July 2008 were included in this study. Subjects with operative or transfusional risk increased by concomitant cardiovascular, autoimmune and/or metabolic pathologies were excluded from the study. All patients were operated by the same surgeon and received the same implant. Patients were randomly allocated in two groups: in the control group A (n=43) only conventional careful haemostasis was performed at the end of the procedure, whilst in the treatment group B (n=35) Quixil application was added. Postoperative haemoglobin (Hb) levels were measured at 12, 24 and 48 hours. Postoperative transfusions of autologous and/or heterologous blood were required when Hb was lower than 8.2 g/dl. The occurrence of haematomas or other complications was also evaluated.

Results: The use of Quixil in THA was associated with reduced postoperative blood loss, lower incidence of haematomas in the operated region, less pain and faster functional rehabilitation. The decrease of Hb levels measured at 12, 24 and 48 hours after the operation was higher in group A (10.3, 9.4, and 8.6 g/dL respectively) than in group B (10.6, 10.0, and 9.3 g/dL). Group A patients also showed a significant increase of blood loss in the drainages and a higher incidence of haematoma in the operated region. A cost benefit assessment of the use of Quixil in THA was also performed.

Conclusions: This is the first randomized study comparing in THA the results of patients treated with fibrin spray with patients treated with conventional haemostasis. A statistically significant reduction of blood loss was observed following the use of fibrin sealant, as well as a decreased requirement of auto/heterologous transfusions. The same treatment group also showed lower incidence of hematomas, less pain and faster rehabilitation. Based on these results, the possibility to perform THA without the requirement of autologous or heterologous transfusions can be predicted in patients with normal preoperative Hb levels and no concomitant pathologies.


Orthopaedic Proceedings
Vol. 91-B, Issue SUPP_I | Pages 145 - 145
1 Mar 2009
Albanese C Lucidi M Rendine M Santori N Pavan L Passariello R Santori F
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Introduction: Bone resorption in the proximal femur is commonly seen after cementless total hip arthroplasty (THA). One of the main determinants of bone remodeling seems to be prosthesis design. With DXA, the amount of bone mass after THA can be precisely determined. We evaluated the BMD behavior of two different ultra-short implants with proximal load transfer, in order to study how a design can affect femoral bone remodeling. The rationale behind these designs is the experimental evidence that loading the medial and the lateral flare effectively preserves in time metaphyseal bone stock. Moreover, biomechanical tests have confirmed that this kind of stress distribution allows to remove the diaphyseal portion of the stem.

Methods: A total of 33 patients operated with a cementless femoral implant were included in this study. Two slightly different designs were tested: Type 1 (Stanmore Orthopaedics), featuring an extremely short distal stem (n=10), and Type 2 (DePuy International Ltd), where distal stem was virtually absent (n=23). All implants were customized based on pre-operative CT data. The main features of these implants were the ultra-short stem and the large lateral flare. The rationale was to preserve bone stock and gain a more physiologic load transfer to the proximal femur thus preventing stress-shielding. DXA examination was performed on all patients 3 years after THA. Due to the peculiar design, a specific protocol of analysis with five regions of interest (ROI) was developed: ROI1 (greater trochanter), ROI2 and ROI4 (respectively lateral and medial of the ultra-short stem), ROI3 (below the tip) and ROI5 (calcar). The same protocol was applied to the non-operated contralateral femur and percentage contralateral BMD was calculated with the following formula: (BMD of operated hip/BMD of contralateral hip)×100. A standard DXA of contralateral hip and lumbar spine was also performed to evaluate the skeletal bone mineralization.

Results: No differences were found in the anthropometric data and sex between the two groups. Age was found lower (p=0.001) in Type 2. BMD of lumbar spine and contralateral femur from standard DXA were not different in the two groups. BMD was higher in Type 2 in ROI4 and ROI5 (p< 0.001). The calculated percentage contralateral BMD was higher in Type 2 in ROI2 (p=0.009), ROI4 (p< 0.001) and ROI5 (p=0.01).

Conclusions: This study confirms that progressive shortening of femoral stem produces a more proximal loading, which effectively preserves in time metaphyseal bone stock and increases periprosthetic BMD in the medial ROIs. The increased BMD in periprosthetic lateral and medial proximal regions in the operated hip respect to the contralateral femur seems to be due not only to the increased weight-bearing, but also to the specific ultra-short stem design.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 54 - 54
1 Mar 2006
Santori F Rendine M Fredella N Manili M Santori N
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Aims: Bone stock preservation is crucial when performing THR in young patients. Previous experiments have confirmed that a physiologic load transfer to the proximal femur has several advantages. First, there is experimental evidence (Fetto et al) that loading the medial and lateral flare effectively preserves in time metaphyseal bone stock. Second, biomechanical tests (Walker et al) have confirmed that with this kind of stress distribution it is possible to remove the diaphyseal portion of the stem.

Following this philosophy, an original ultra-short stem with extensive proximal load transfer was developed. Purpose of this paper is to present clinical and radiological results at 4 yrs average follow up.

Methods: Since June 1995, we implanted 118 stems in 101 patients. Average age at the time of surgery was 51 yrs (30-63) All operations were performed by the senior Author (FFS). Particular care was taken in preserving all the femoral neck and the trochanteric muscles. All implants were customised based on pre-operative CT data. Harris Hip Score (HHS) formed the basis of the clinical assessment. Serial post-operative AP and lateral radiographs were taken for all patients.

Result: Patients were followed-up for up to 9 years (mean follow-up 45 months) and results showed no stem related revisions or infections. The mean HHS increased from 44.8 pre-operatively to 98.6 post-operatively at the latest follow-up. Tight pain was recorded only in one case. Other complications included 2 dislocations, one trapped drain and 2 superficial wound infections. All stems appeared radiografically stable with a well maintained proximal bone stock. No radiolucent lines have appeared around the stem.

Conclusions: Results obtained in this group of relatively young patients have been encouraging. Clinical and radiographic results validate the assumption that torsional loads can be controlled even without the diaphy-seal portion of the stem. Neck preservation combined with lateral flare support guarantees a more natural loading of the femur. The absence of the stem makes this implant ideal for less invasive surgery.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 55 - 55
1 Mar 2006
Santori F Albanese C Rendine M Duffy G Learmonth I
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Introduction Significant cortical bone mass has been demonstrated at the proximo-lateral flare of the femur (Fetto et al). Experiments have shown that if a femoral stem has a medial and lateral flare proximally, the loads are transferred to the proximal femur and stress protection in this area is avoided. Furthermore, the results suggested that a stem below the lesser trochanter was unnecessary (Walker et al).

Methodology This paper reports on two cohorts of ten patients that had either a short stemmed fully coated implant (Group I) or an unstemmed metaphyseal implant on which all but the polished tip was coated (Group II). All implants were customised based on pre-operative CT data. All hips had serial post-operative AP and lateral radiographs and bone densitometry was assessed with DEXA scanning.

Results The most recent post-operative radiographs of all patients in Group I revealed buttressing in zone IV with trabeculae streaming from the cortices onto the tip of the stem. Qualitatively there appeared to be osteope-nia in Gruen zones I and VII. The x-rays of the Group II patients revealed good condensation of bone along the textured surface in zone I and VII with preservation of bone density in these regions. These findings were confirmed by the DEXA results which showed a reduction of the BMD in zones I and VII in Group I, while Group II revealed preservation of the BMD in these zones.

Conclusion A conservative prosthesis without a stem which effectively loads both medial and lateral proximal femoral flares not only removes less bone at the index operation but preserves proximal bone stock in the longer term.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 139 - 139
1 Mar 2006
Santori N Piccinato A Lo Storto A Campi A Santori F
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Purpose: Operative treatment of diaphyseal humeral fractures is indicated for transverse displaced fractures, pathological or impending fractures, non unions, fractures with radial nerve palsy and oblique fractures after conservative treatment failure.

Different techniques are available but many surgeons have recently expressed a preference for retrograde nailing. We present our results with new generation retrograde self-locking nail.

Methodology: From 1998 to 2004, we treated 112 patients with the cannulated retrograde EXP nail (LIMA LTO). All patient have been operated in the prone position on a conventional orthopaedic table.

Proximal locking, in this device, is obtained by the angled protrusion of a wire from the nail proximal extremity. Experimental tests in the lab have confirmed the excellent torsion stability of this mechanism.

Distally, the EXP nail has two little wings shaped to sit on the medial and lateral columns of the olecranic fossa and to thus provide an effective rotational and traction control.

We treated 67 traumatic fracture, 15 pathological fractures, 10 impending fracture and 20 a non-unions. 10 patients in this series were obese.

Results: Average surgical time was 40 minutes (min 30 – max 110). Average radiation exposure was 1 minute and 15 seconds (20 seconds for proximal locking).

Union was obtained in all the 67 primary fractures and stability was secured for all the impending and pathological cases. All but 1 non-union healed after an average of 2.6 months. In 2 patients of the primary fractures and in 3 patients of the non-union group we had a delayed union. The 3 non-union patients healed after 5, 7 and 9 months respectively. Overall 9 of the 10 obese patients healed. No patients suffered shoulder pain. In 8 cases a reduction of less than 10 degrees of elbow extension was detected. Forty-five nails have been removed so far after an average of 11 months after nailing. No major problems in nail removal have been encountered.

Conclusions: Retrograde nailing of the humerus presents significant advantages over other techniques and is meeting more and more consensus. The nail employed in this series provides satisfactory stability, it is cannulated and requires minimal radiation exposure.


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 54 - 54
1 Mar 2006
Albanese C Rendine M Lanciotti K de Palma F Impagliazzo A Falez F Postacchini F Villani C Santori F
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Introduction A wide range of stress-shielding phenomena following THA have been described in the past 20 years. Bone densitometry (DXA) stars as a golden standard in evaluating bone stock and bone density redistribution after total hip replacement.

In this study, DXA scan was employed to evaluate and compare the behaviour of different femoral components including a recently developed stemless implant which features complete stress transfer over the proximal femur.

Methodology A total of 120 patients, operated with six different femoral implants, were included in the present study. Five of these stems are widely commercially available (ABG, CFP, IPS, Mayo, Zweymueller) and present different patterns of stress distribution. The sixth is a custom made implant and features a pronounced lateral flare and complete femoral neck preservation. Rationale of this design is to obtain full load transfer on the proximal femur.

Average interval between the operation and the DXA exam was 3 years, each group included 20 patients. Bone mineral density was measured by DXA in the seven Gruen femoral regions (ROI), using the software metal removal (Hologic QDR 4500 W, MA-USA).

Results Differences in bone density were found in each group as well as between different groups. Significant differences (p< 0.001) were found between the stemless implant and the other five groups in zone I, IV and VII.

CFP, IPS and ABG groups showed decreased bone density in ROI I, while Mayo, IPS, ABG and Zweym-ueller were osteopenic in ROI VII. An increased bone density in ROI IV was found in Zweymueller, Mayo, ABG and IPS groups.

Conclusion Our data suggest that a conservative stemless implant with complete proximal load transfer, produces a homogeneous and more physiologic redistribution of bone density, allowing maintenance of proximal periprosthetic bone stock.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 247 - 247
1 Mar 2004
Santori N Santori F Fredella N Campi A
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Aims: Most diaphyseal humeral fractures must be treated conservatively. Surgery is indicated for transverse displaced fractures, pathological or impending fractures, non unions, fractures with radial nerve palsy and oblique fractures after conservative treatment failure. Methods: Between March 1998 and July 2001 we operated on 80 patients with a diaphyseal humeral fracture. The cannulated retrograde EXP nail (LIMA LTO) was always employed. Proximal locking is obtained through the nail by causing angled protrusion of a wire from the proximal end of it and into the spongious (cancellous) bone of the humeral head. Distally the EXP nail has two little wings shaped to sit on the medial and lateral columns of the olecranic fossa and to thus provide a very effective rotational and traction control. In 51 cases it was a traumatic fracture; transverse, oblique unstable or polytrauma. In 10 cases a pathological fractures, in 7 an impending fracture, in 12 a nonunion. Nonunion cases had had a previous average of 2.5 operations. 10 patients were obese. Results: Average surgical time was 40 minutes. Average radiation exposure was 1 minute and 40 seconds. Union was obtained in all the 51 primary fractures and stability was secured for all the impending and pathological cases. All but 1 of the non-unions healed after an average of 2.6 months. The one failure was in an obese 65 yrs old lady with an oblique unstable non-union. No patients suffered shoulder pain. In 4 cases a reduction of less than 10 degrees of elbow extension was detected. Conclusions: The EXP humeral nail provides satisfactory stability, it is cannulated and requires minimal radiation exposure.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 275 - 275
1 Mar 2004
Santori F Vitullo A Fredella N Santori N
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Aims: Stemmed cup is the evolution of Ring cup. The iliac stem is positioned in direction of sacro-iliac sin-condrosis, in axis with weight-bearing lines. It allows an optimal stability in the iliac bone avoiding the dameged acetabular region. The stemmed cup is indicated:

Ð in CDH primary implant

Ð in revision surgery (grade 2–4 according to Paproskyñs classiþcation). In severe bone loss cases (grade 3–4) we preferred to use auto or homologous bone grafts impacted to þll the bone defect. Methods:We report about 168 stemmed cup implants in 159 patients (9 bilateral cases). 37 CDH was treated as a primary implant (6 bilateral patients). The average age is 69 years (range 38–87). The mean follow up is 36 months (range 6 months Ð 6 years). 21 cases were lost at follow up. We evaluated all patients by X-rays at 1,3,6 months and every year and CT in some cases to check the iliac stem position. Results: 13 patients died because of non-related surgery. Superþcial infections 5 cases; deep infections 6 cases (two-stages revision); proximal migration < 1 cm. In 9 cases without loosening; malpositioning of the stem 7 cases; sciatic nerve palsy 5 cases (1 permanent case); DVT 3 cases.

Radiolucency around stem < 2 mm. 19 cases, radiolucency around the cup in 11 cases; bone grafts resorption 10 out of 57 cases. Mean preoperative Harris Hip Score was 60; mean postoperative HHS 85. Conclusions: The good mid-term results reported conþrm that stemmed cup is a valid solution in revision surgery with mid and severe bone loss but also in CDH when conventional cup are not indicated.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 369 - 370
1 Mar 2004
Vitullo A Santori N Fredella N Santori F
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Aims: Avascular necrosis of the femoral head (AVN) evolves in destruction of the hip joint. Treatment of this disease is controversial. Early stages are treated with core decompression whilst in later stages þbular grafting, rotational osteotomy or THR are recommended. Purpose of this study is the evaluation of a new combined approach. Methods: We present a series of 147 AVN in 108 patients treated with the combination of core decompression, bone grafting and electrical stimulation. All surgery were performed with a minimal invasive technique and a dedicated set of instruments which allow for accurate and complete removal of the necrotic bone.

In 30 cases the disease was in Steinberg stage I, 58 stage II, 42 stage III and 17 stage IV. All patients were kept non weight bearing for 6 weeks and partial weight bearing for further 6 to 8 weeks. PEMF were used for 8 ours daily for 3 months. Average follow-up was 37 months (min 12 months, max 108). Both clinical and radiological results were evaluated. Results: We had a good radiographic result in 96% of cases in stage I, 85% stage II, 45% stage III and 27% stage IV. Clinically, we obtained good results in 87% stage I, in 81% stage II, in 65% stage III and in 48% stage IV. Clinical failure was deþned as the performance of a subsequent operation. None of the patients in stage I or II required further surgical treatment. Nine cases in stage III and 5 in stage IV required THR after an average of 19 months. Conclusions: Core decompression with bone grafting and electrical stimulation is a safe and effective procedure in Stage I and Stage II AVN. Promising results were obtained also in stage III and Stage IV.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_III | Pages 279 - 280
1 Mar 2004
Santori F Manili M Fredella N Santori N
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Aims: Bone stock preservation is thought to be essential when performing THR in young patients. For this purpose we developed a new CAD-CAM titanium cementless femoral stem to be implanted with minimal femoral resection. This implant is constructed to þll completely the proximal metaphysis transferring loads on both the lateral ßare and the calcar. This allows the elimination of the diaphyseal portion of the stem which is prolonged only till approximately 1 centimetre below the lesser tro-canter. Methods: Since 1995, we implanted 76 stems in 71 patients. Average age was 51 yrs (30–63), 34 females and 37 males. Mean follow-up is 45 months (min.12, max 84 months). In all cases we employed an hemispherical pressþt cup. Metal to polyethylene interface was used in the þrst 30 implants whilst metal to metal coupling was chosen for the latter 46 hips. Clinically patients were evaluated with Harris Hip Score. All patients ware evaluated by X-ray 1, 3, 6 and every year postoperative. Results: Average preoperative value of HHS was 42,4, postoperative 98. Tight pain was never recorded. All the stems appear stable radiograþcally, we had no subsidence, no radiolucent lines, no stress shielding, no osteolisis. In 26,4% of cases we had mild proximal calcar resorption. Conclusions: Clinical and radiographic results conþrm that axial and torsional loads can be properly controlled even without the distal portion of the stem. We believe that maximal bone stock preservation in young patients undergoing THR is mandatory in view of the high possibility for these patients to require multiple revisions in the future.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 277 - 278
1 Nov 2002
Santori F Santori N
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Introduction: Stem alignment and cement mantle thickness influence stress distribution on the cement-bone and the bone-cement interfaces. Malposition of the implant and an incomplete cement mantle can lead to suboptimal long-term results. The proximal and distal centralisers that are currently available have shown severe limitations in their clinical application and do not centralise the stem in the lateral plane.

Aim: To evaluate a new stem-positioning system.

Method: One hundred Friendly (Lima LTO) stems implanted between October 1999 and October 2000 have been evaluated radiographically for stem centralisation and cement mantle thickness in both projections. One surgeon used the same technique in all patients and employed a newly designed set of proximal and distal centralisers.

Results: All cases had an acceptable and complete cement mantle. In only seven cases cement thickness was below 2mm in Gruen zone 14. Stem-bone contact was never observed. No patient had migration of the distal plug during pressurisation or complete cement defects. In eight cases mild (2 degrees to 4 degrees) valgus deviation of the stem was found. None of the distal centralisers failed whilst one of the proximal centralisers broke during insertion of the stem without influencing the final result.

Discussion: Cementing the stem is the most delicate phase of cemented total hip replacement. The use of proximal and distal centralisers is mandatory to prevent malposition which in turn results in incomplete cement mantle. The system employed in this series appears accurate and reproducible for stem alignment.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 280 - 280
1 Nov 2002
Santori F Santori N
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Introduction: Most diaphyseal humeral fractures can be successfully treated with conservative treatment. Nailing is indicated for transverse displaced fractures, pathological or impending fractures, non-unions, fractures with a radial nerve palsy and oblique fractures after failure of conservative treatment. Most surgeons prefer the distal retrograde approach to the humeral canal because of the high incidence of chronic shoulder pain after proximal nailing. However, when using such an approach targeting the holes for proximal static locking is demanding and time consuming. The EXP nail (LIMA LTO) is cannulated and has an original self-looking mechanism that is designed to match the advantages of the retrograde approach. These include rapid proximal locking and reduced radiation exposure.

The proximal locking is achieved by the protrusion of a wire into the medullary bone of the humeral head. Distally the EXP nail has two small wings shaped to sit on the medial and lateral columns of the olecranon fossa.

Cases: We implanted 56 EXP nails in 56 patients. The average surgical time was 40 minutes (min 30, max 110). The average radiation exposure was one minute and 40 seconds (20 seconds for proximal locking). In all cases we obtained fracture union and no patients suffered shoulder pain. In four cases elbow extension was reduced by less than 10. In one case the nail broke but the fracture united.

Conclusions: The EXP humeral nail provides satisfactory stability, it is cannulated and requires minimal radiation exposure.


The Journal of Bone & Joint Surgery British Volume
Vol. 76-B, Issue 4 | Pages 579 - 583
1 Jul 1994
Santori F Vitullo A Stopponi M Santori N Ghera S

We performed a randomised controlled study to compare heparin with the A-V Impulse System in the prevention of deep-vein thrombosis (DVT) in 132 consecutive patients undergoing total hip replacement. After the operation, all patients had compression stockings, 65 were treated with calcium heparin and 67 with the intermittent plantar pump. DVT was diagnosed by Doppler ultrasound and thermography, followed by phlebography. There were 23 cases of DVT (35.4%) in the heparin group, with 16 major and seven minor thromboses. In the impulse pump group there were nine cases (13.4%) with three major and six minor thromboses. The differences for all thromboses and for major thromboses were both significant at p < 0.005. In the heparin group there was one fatal pulmonary embolism and nine patients (13.8%) had excessive bleeding or wound haematomas, as against none in the impulse pump group.