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Bone & Joint Open
Vol. 5, Issue 6 | Pages 452 - 456
1 Jun 2024
Kennedy JW Rooney EJ Ryan PJ Siva S Kennedy MJ Wheelwright B Young D Meek RMD

Aims. Femoral periprosthetic fractures are rising in incidence. Their management is complex and carries a high associated mortality. Unlike native hip fractures, there are no guidelines advising on time to theatre in this group. We aim to determine whether delaying surgical intervention influences morbidity or mortality in femoral periprosthetic fractures. Methods. We identified all periprosthetic fractures around a hip or knee arthroplasty from our prospectively collated database between 2012 and 2021. Patients were categorized into early or delayed intervention based on time from admission to surgery (early = ≤ 36 hours, delayed > 36 hours). Patient demographics, existing implants, Unified Classification System fracture subtype, acute medical issues on admission, preoperative haemoglobin, blood transfusion requirement, and length of hospital stay were identified for all patients. Complication and mortality rates were compared between groups. Results. A total of 365 patients were identified: 140 in the early and 225 in the delayed intervention group. Mortality rate was 4.1% at 30 days and 19.2% at one year. There was some indication that those who had surgery within 36 hours had a higher mortality rate, but this did not reach statistical significance at 30 days (p = 0.078) or one year (p = 0.051). Univariate analysis demonstrated that age, preoperative haemoglobin, acute medical issue on admission, and the presence of postoperative complications influenced 30-day and one-year mortality. Using a multivariate model, age and preoperative haemoglobin were independently predictive factors for one-year mortality (odds ratio (OR) 1.071; p < 0.001 and OR 0.980; p = 0.020). There was no association between timing of surgery and postoperative complications. Postoperative complications were more likely with increasing age (OR 1.032; p = 0.001) and revision arthroplasty compared to internal fixation (OR 0.481; p = 0.001). Conclusion. While early intervention may be preferable to reduce prolonged immobilization, there is no evidence that delaying surgery beyond 36 hours increases mortality or complications in patients with a femoral periprosthetic fracture. Cite this article: Bone Jt Open 2024;5(6):452–456


Bone & Joint Research
Vol. 2, Issue 5 | Pages 79 - 83
1 May 2013
Goffin JM Pankaj P Simpson AHRW Seil R Gerich TG

Objectives. Because of the contradictory body of evidence related to the potential benefits of helical blades in trochanteric fracture fixation, we studied the effect of bone compaction resulting from the insertion of a proximal femoral nail anti-rotation (PFNA). . Methods. We developed a subject-specific computational model of a trochanteric fracture (31-A2 in the AO classification) with lack of medial support and varied the bone density to account for variability in bone properties among hip fracture patients. Results. We show that for a bone density corresponding to 100% of the bone density of the cadaveric femur, there does not seem to be any advantage in using a PFNA with respect to the risk of blade cut-out. On the other hand, in a more osteoporotic femoral head characterised by a density corresponding to 75% of the initial bone density, local bone compaction around the helical blade provides additional bone purchase, thereby decreasing the risk of cut-out, as quantified by the volume of bone susceptible to yielding. Conclusions. Our findings indicate benefits of using a PFNA over an intramedullary nail with a conventional lag screw and suggest that any clinical trial reporting surgical outcomes regarding the use of helical blades should include a measure of the femoral head bone density as a covariable


Bone & Joint Research
Vol. 1, Issue 6 | Pages 104 - 110
1 Jun 2012
Swinteck BJ Phan DL Jani J Owen JR Wayne JS Mounasamy V

Objectives

The use of two implants to manage concomitant ipsilateral femoral shaft and proximal femoral fractures has been indicated, but no studies address the relationship of dynamic hip screw (DHS) side plate screws and the intramedullary nail where failure might occur after union. This study compares different implant configurations in order to investigate bridging the gap between the distal DHS and tip of the intramedullary nail.

Methods

A total of 29 left synthetic femora were tested in three groups: 1) gapped short nail (GSN); 2) unicortical short nail (USN), differing from GSN by the use of two unicortical bridging screws; and 3) bicortical long nail (BLN), with two angled bicortical and one unicortical bridging screws. With these findings, five matched-pairs of cadaveric femora were tested in two groups: 1) unicortical long nail (ULN), with a longer nail than USN and three bridging unicortical screws; and 2) BLN. Specimens were axially loaded to 22.7 kg (50 lb), and internally rotated 90°/sec until failure.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 37 - 45
19 Jan 2024
Alm CE Karlsten A Madsen JE Nordsletten L Brattgjerd JE Pripp AH Frihagen F Röhrl SM

Aims. Despite limited clinical scientific backing, an additional trochanteric stabilizing plate (TSP) has been advocated when treating unstable trochanteric fractures with a sliding hip screw (SHS). We aimed to explore whether the TSP would result in less post operative fracture motion, compared to SHS alone. Methods. Overall, 31 patients with AO/OTA 31-A2 trochanteric fractures were randomized to either a SHS alone or a SHS with an additional TSP. To compare postoperative fracture motion, radiostereometric analysis (RSA) was performed before and after weightbearing, and then at four, eight, 12, 26, and 52 weeks. With the “after weightbearing” images as baseline, we calculated translations and rotations, including shortening and medialization of the femoral shaft. Results. Similar migration profiles were observed in all directions during the course of healing. At one year, eight patients in the SHS group and 12 patients in the TSP group were available for analysis, finding a clinically non-relevant, and statistically non-significant, difference in total translation of 1 mm (95% confidence interval -4.7 to 2.9) in favour of the TSP group. In line with the migration data, no significant differences in clinical outcomes were found. Conclusion. The TSP did not influence the course of healing or postoperative fracture motion compared to SHS alone. Based on our results, routine use of the TSP in AO/OTA 31-A2 trochanteric fractures cannot be recommended. The TSP has been shown, in biomechanical studies, to increase stability in sliding hip screw constructs in both unstable and intermediate stable trochanteric fractures, but the clinical evidence is limited. This study showed no advantage of the TSP in unstable (AO 31-A2) fractures in elderly patients when fracture movement was evaluated with radiostereometric analysis. Cite this article: Bone Jt Open 2024;5(1):37–45


Bone & Joint Open
Vol. 4, Issue 9 | Pages 659 - 667
1 Sep 2023
Nasser AAHH Osman K Chauhan GS Prakash R Handford C Nandra RS Mahmood A

Aims

Periprosthetic fractures (PPFs) following hip arthroplasty are complex injuries. This study evaluates patient demographic characteristics, management, outcomes, and risk factors associated with PPF subtypes over a decade.

Methods

Using a multicentre collaborative study design, independent of registry data, we identified adults from 29 centres with PPFs around the hip between January 2010 and December 2019. Radiographs were assessed for the Unified Classification System (UCS) grade. Patient and injury characteristics, management, and outcomes were compared between UCS grades. A multinomial logistic regression was performed to estimate relative risk ratios (RRR) of variables on UCS grade.


Bone & Joint Open
Vol. 4, Issue 8 | Pages 602 - 611
21 Aug 2023
James HK Pattison GTR Griffin J Fisher JD Griffin DR

Aims

To evaluate if, for orthopaedic trainees, additional cadaveric simulation training or standard training alone yields superior radiological and clinical outcomes in patients undergoing dynamic hip screw (DHS) fixation or hemiarthroplasty for hip fracture.

Methods

This was a preliminary, pragmatic, multicentre, parallel group randomized controlled trial in nine secondary and tertiary NHS hospitals in England. Researchers were blinded to group allocation. Overall, 40 trainees in the West Midlands were eligible: 33 agreed to take part and were randomized, five withdrew after randomization, 13 were allocated cadaveric training, and 15 were allocated standard training. The intervention was an additional two-day cadaveric simulation course. The control group received standard on-the-job training. Primary outcome was implant position on the postoperative radiograph: tip-apex distance (mm) (DHS) and leg length discrepancy (mm) (hemiarthroplasty). Secondary clinical outcomes were procedure time, length of hospital stay, acute postoperative complication rate, and 12-month mortality. Procedure-specific secondary outcomes were intraoperative radiation dose (for DHS) and postoperative blood transfusion requirement (hemiarthroplasty).


Bone & Joint Open
Vol. 5, Issue 6 | Pages 457 - 463
2 Jun 2024
Coviello M Abate A Maccagnano G Ippolito F Nappi V Abbaticchio AM Caiaffa E Caiaffa V

Aims

Proximal femur fractures treatment can involve anterograde nailing with a single or double cephalic screw. An undesirable failure for this fixation is screw cut-out. In a single-screw nail, a tip-apex distance (TAD) greater than 25 mm has been associated with an increased risk of cut-out. The aim of the study was to examine the role of TAD as a risk factor in a cephalic double-screw nail.

Methods

A retrospective study was conducted on 112 patients treated for intertrochanteric femur fracture with a double proximal screw nail (Endovis BA2; EBA2) from January to September 2021. The analyzed variables were age, sex, BMI, comorbidities, fracture type, side, time of surgery, quality of reduction, pre-existing therapy with bisphosphonate for osteoporosis, screw placement in two different views, and TAD. The last follow-up was at 12 months. Logistic regression was used to study the potential factors of screw cut-out, and receiver operating characteristic curve to identify the threshold value.


Bone & Joint Open
Vol. 5, Issue 2 | Pages 147 - 153
19 Feb 2024
Hazra S Saha N Mallick SK Saraf A Kumar S Ghosh S Chandra M

Aims

Posterior column plating through the single anterior approach reduces the morbidity in acetabular fractures that require stabilization of both the columns. The aim of this study is to assess the effectiveness of posterior column plating through the anterior intrapelvic approach (AIP) in the management of acetabular fractures.

Methods

We retrospectively reviewed the data from R G Kar Medical College, Kolkata, India, from June 2018 to April 2023. Overall, there were 34 acetabulum fractures involving both columns managed by medial buttress plating of posterior column. The posterior column of the acetabular fracture was fixed through the AIP approach with buttress plate on medial surface of posterior column. Mean follow-up was 25 months (13 to 58). Accuracy of reduction and effectiveness of this technique were measured by assessing the Merle d’Aubigné score and Matta’s radiological grading at one year and at latest follow-up.


Bone & Joint Open
Vol. 4, Issue 2 | Pages 104 - 109
20 Feb 2023
Aslam AM Kennedy J Seghol H Khisty N Nicols TA Adie S

Aims

Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients.

Methods

This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively.


Bone & Joint Open
Vol. 4, Issue 7 | Pages 516 - 522
10 Jul 2023
Mereddy P Nallamilli SR Gowda VP Kasha S Godey SK Nallamilli RR GPRK R Meda VGR

Aims

Musculoskeletal infection is a devastating complication in both trauma and elective orthopaedic surgeries that can result in significant morbidity. Aim of this study was to assess the effectiveness and complications of local antibiotic impregnated dissolvable synthetic calcium sulphate beads (Stimulan Rapid Cure) in the hands of different surgeons from multiple centres in surgically managed bone and joint infections.

Methods

Between January 2019 and December 2022, 106 patients with bone and joint infections were treated by five surgeons in five hospitals. Surgical debridement and calcium sulphate bead insertion was performed for local elution of antibiotics in high concentration. In all, 100 patients were available for follow-up at regular intervals. Choice of antibiotic was tailor made for each patient in consultation with microbiologist based on the organism grown on culture and the sensitivity. In majority of our cases, we used a combination of vancomycin and culture sensitive heat stable antibiotic after a thorough debridement of the site. Primary wound closure was achieved in 99 patients and a split skin graft closure was done in one patient. Mean follow-up was 20 months (12 to 30).


Bone & Joint Open
Vol. 3, Issue 9 | Pages 710 - 715
5 Sep 2022
Khan SK Tyas B Shenfine A Jameson SS Inman DS Muller SD Reed MR

Aims

Despite multiple trials and case series on hip hemiarthroplasty designs, guidance is still lacking on which implant to use. One particularly deficient area is long-term outcomes. We present over 1,000 consecutive cemented Thompson’s hemiarthroplasties over a ten-year period, recording all accessible patient and implant outcomes.

Methods

Patient identifiers for a consecutive cohort treated between 1 January 2003 and 31 December 2011 were linked to radiographs, surgical notes, clinic letters, and mortality data from a national dataset. This allowed charting of their postoperative course, complications, readmissions, returns to theatre, revisions, and deaths. We also identified all postoperative attendances at the Emergency and Outpatient Departments, and recorded any subsequent skeletal injuries.


The Bone & Joint Journal
Vol. 102-B, Issue 2 | Pages 162 - 169
1 Feb 2020
Hoellwarth JS Tetsworth K Kendrew J Kang NV van Waes O Al-Maawi Q Roberts C Al Muderis M

Aims. Osseointegrated prosthetic limbs allow better mobility than socket-mounted prosthetics for lower limb amputees. Fractures, however, can occur in the residual limb, but they have rarely been reported. Approximately 2% to 3% of amputees with socket-mounted prostheses may fracture within five years. This is the first study which directly addresses the risks and management of periprosthetic osseointegration fractures in amputees. Methods. A retrospective review identified 518 osseointegration procedures which were undertaken in 458 patients between 2010 and 2018 for whom complete medical records were available. Potential risk factors including time since amputation, age at osseointegration, bone density, weight, uni/bilateral implantation and sex were evaluated with multiple logistic regression. The mechanism of injury, technique and implant that was used for fixation of the fracture, pre-osseointegration and post fracture mobility (assessed using the K-level) and the time that the prosthesis was worn for in hours/day were also assessed. Results. There were 22 periprosthetic fractures; they occurred exclusively in the femur: two in the femoral neck, 14 intertrochanteric and six subtrochanteric, representing 4.2% of 518 osseointegration operations and 6.3% of 347 femoral implants. The vast majority (19/22, 86.4%) occurred within 2 cm of the proximal tip of the implant and after a fall. No fractures occurred spontaneously. Fixation most commonly involved dynamic hip screws (10) and reconstruction plates (9). No osseointegration implants required removal, the K-level was not reduced after fixation of the fracture in any patient, and all retained a K-level of ≥ 2. All fractures united, 21 out of 22 patients (95.5%) wear their osseointegration-mounted prosthetic limb longer daily than when using a socket, with 18 out of 22 (81.8%) reporting using it for ≥ 16 hours daily. Regression analysis identified a 3.89-fold increased risk of fracture for females (p = 0.007) and a 1.02-fold increased risk of fracture per kg above a mean of 80.4 kg (p = 0.046). No increased risk was identified for bilateral implants (p = 0.083), time from amputation to osseointegration (p = 0.974), age at osseointegration (p = 0.331), or bone density (g/cm2, p = 0.560; T-score, p = 0.247; Z-score, p = 0.312). Conclusion. The risks and sequelae of periprosthetic fracture after press-fit osseointegration for amputation should not deter patients or clinicians from considering this procedure. Females and heavier patients are likely to have an increased risk of fracture. Age, years since amputation, and bone density do not appear influential. Cite this article: Bone Joint J 2020;102-B(2):162–169


Bone & Joint Open
Vol. 3, Issue 2 | Pages 165 - 172
21 Feb 2022
Kuwahara Y Takegami Y Tokutake K Yamada Y Komaki K Ichikawa T Imagama S

Aims

Postoperative malalignment of the femur is one of the main complications in distal femur fractures. Few papers have investigated the impact of intraoperative malalignment on postoperative function and bone healing outcomes. The aim of this study was to investigate how intraoperative fracture malalignment affects postoperative bone healing and functional outcomes.

Methods

In total, 140 patients were retrospectively identified from data obtained from a database of hospitals participating in a trauma research group. We divided them into two groups according to coronal plane malalignment of more than 5°: 108 had satisfactory fracture alignment (< 5°, group S), and 32 had unsatisfactory alignment (> 5°, group U). Patient characteristics and injury-related factors were recorded. We compared the rates of nonunion, implant failure, and reoperation as healing outcomes and Knee Society Score (KSS) at three, six, and 12 months as functional outcomes. We also performed a sub-analysis to assess the effect of fracture malalignment by plates and nails on postoperative outcomes.


Bone & Joint Open
Vol. 2, Issue 2 | Pages 72 - 78
1 Feb 2021
Agni NR Costa ML Achten J O’Connor H Png ME Peckham N Dutton SJ Wallis S Milca S Reed M

Aims

Patients receiving cemented hemiarthroplasties after hip fracture have a significant risk of deep surgical site infection (SSI). Standard UK practice to minimize the risk of SSI includes the use of antibiotic-loaded bone cement with no consensus regarding type, dose, or antibiotic content of the cement. This is the protocol for a randomized clinical trial to investigate the clinical and cost-effectiveness of high dose dual antibiotic-loaded cement in comparison to low dose single antibiotic-loaded cement in patients 60 years and over receiving a cemented hemiarthroplasty for an intracapsular hip fracture.

Methods

The WHiTE 8 Copal Or Palacos Antibiotic Loaded bone cement trial (WHiTE 8 COPAL) is a multicentre, multi-surgeon, parallel, two-arm, randomized clinical trial. The pragmatic study will be embedded in the World Hip Trauma Evaluation (WHiTE) (ISRCTN 63982700). Participants, including those that lack capacity, will be allocated on a 1:1 basis stratified by recruitment centre to either a low dose single antibiotic-loaded bone cement or a high dose dual antibiotic-loaded bone cement. The primary analysis will compare the differences in deep SSI rate as defined by the Centers for Disease Control and Prevention within 90 days of surgery via medical record review and patient self-reported questionnaires. Secondary outcomes include UK Core Outcome Set for hip fractures, complications, rate of antibiotic prescription, resistance patterns of deep SSI, and resource use (more specifically, cost-effectiveness) up to four months post-randomization. A minimum of 4,920 patients will be recruited to obtain 90% power to detect an absolute difference of 1.5% in the rate of deep SSI at 90 days for the expected 3% deep SSI rate in the control group.


Bone & Joint Open
Vol. 1, Issue 9 | Pages 568 - 575
18 Sep 2020
Dayananda KSS Mercer ST Agarwal R Yasin T Trickett RW

Aims

COVID-19 necessitated abrupt changes in trauma service delivery. We compare the demographics and outcomes of patients treated during lockdown to a matched period from 2019. Findings have important implications for service development.

Methods

A split-site service was introduced, with a COVID-19 free site treating the majority of trauma patients. Polytrauma, spinal, and paediatric trauma patients, plus COVID-19 confirmed or suspicious cases, were managed at another site. Prospective data on all trauma patients undergoing surgery at either site between 16 March 2020 and 31 May 2020 was collated and compared with retrospective review of the same period in 2019. Patient demographics, injury, surgical details, length of stay (LOS), COVID-19 status, and outcome were compared.


Bone & Joint Research
Vol. 5, Issue 5 | Pages 191 - 197
1 May 2016
Kienast B Kowald B Seide K Aljudaibi M Faschingbauer M Juergens C Gille J

Objectives. The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. Materials and Methods. An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur. Results. A total of 39 cases of clinical application were reviewed for this study. In total, four different types of healing curves were observed: fast healing; slow healing; plateau followed by healing; and non-healing. Conclusion. The electronically instrumented internal fixator proved to be valuable for the assessment of bone healing in difficult healing situations. Cost-effective manufacturing is possible because the used electronic components are derived from large-scale production. The incorporation of microelectronics into orthopaedic implants will be an important innovation in future clinical care. Cite this article: B. Kienast, B. Kowald, K. Seide, M. Aljudaibi, M. Faschingbauer, C. Juergens, J. Gille. An electronically instrumented internal fixator for the assessment of bone healing. Bone Joint Res 2016;5:191–197. DOI: 10.1302/2046-3758.55.2000611


The Bone & Joint Journal
Vol. 100-B, Issue 9 | Pages 1234 - 1240
1 Sep 2018
Brady J Hardy BM Yoshino O Buxton A Quail A Balogh ZJ

Aims

Little is known about the effect of haemorrhagic shock and resuscitation on fracture healing. This study used a rabbit model with a femoral osteotomy and fixation to examine this relationship.

Materials and Methods

A total of 18 male New Zealand white rabbits underwent femoral osteotomy with intramedullary fixation with ‘shock’ (n = 9) and control (n = 9) groups. Shock was induced in the study group by removal of 35% of the total blood volume 45 minutes before resuscitation with blood and crystalloid. Fracture healing was monitored for eight weeks using serum markers of healing and radiographs.


Bone & Joint Research
Vol. 6, Issue 3 | Pages 144 - 153
1 Mar 2017
Kharwadkar N Mayne B Lawrence JE Khanduja V

Objectives

Bisphosphonates are widely used as first-line treatment for primary and secondary prevention of fragility fractures. Whilst they have proved effective in this role, there is growing concern over their long-term use, with much evidence linking bisphosphonate-related suppression of bone remodelling to an increased risk of atypical subtrochanteric fractures of the femur (AFFs). The objective of this article is to review this evidence, while presenting the current available strategies for the management of AFFs.

Methods

We present an evaluation of current literature relating to the pathogenesis and treatment of AFFs in the context of bisphosphonate use.


Bone & Joint Research
Vol. 5, Issue 1 | Pages 18 - 25
1 Jan 2016
Sims AL Parsons N Achten J Griffin XL Costa ML Reed MR

Background

Approximately half of all hip fractures are displaced intracapsular fractures. The standard treatment for these fractures is either hemiarthroplasty or total hip arthroplasty. The recent National Institute for Health and Care Excellence (NICE) guidance on hip fracture management recommends the use of ‘proven’ cemented stem arthroplasty with an Orthopaedic Device Evaluation Panel (ODEP) rating of at least 3B (97% survival at three years). The Thompsons prosthesis is currently lacking an ODEP rating despite over 50 years of clinical use, likely due to the paucity of implant survival data. Nationally, adherence to these guidelines is varied as there is debate as to which prosthesis optimises patient outcomes.

Design

This study design is a multi-centre, multi-surgeon, parallel, two arm, standard-of-care pragmatic randomised controlled trial. It will be embedded within the WHiTE Comprehensive Cohort Study (ISRCTN63982700). The main analysis is a two-way equivalence comparison between Hemi-Thompson and Hemi-Exeter polished taper with Unitrax head. Secondary outcomes will include radiological leg length discrepancy measured as per Bidwai and Willett, mortality, re-operation rate and indication for re-operation, length of index hospital stay and revision at four months. This study will be supplemented by the NHFD (National Hip Fracture Database) dataset.


Bone & Joint Research
Vol. 3, Issue 6 | Pages 187 - 192
1 Jun 2014
Penn-Barwell JG Rand BCC Brown KV Wenke JC

Objectives

The purpose of this study was to refine an accepted contaminated rat femur defect model to result in an infection rate of approximately 50%. This threshold will allow examination of treatments aimed at reducing infection in open fractures with less risk of type II error.

Methods

Defects were created in the stablised femurs of anaethetised rats, contaminated with Staphylococcus aureus and then debrided and irrigated six hours later. After 14 days, the bone and implants were harvested for separate microbiological analysis. This basic model was developed in several studies by varying the quantity of bacterial inoculation, introducing various doses of systemic antibiotics with and without local antibiotics.