Clinical trial NCT02951884
Conditions: Tibial Fractures
Keywords: Aspiration Bupivacaine Epinephrine Marcaine Pain Shin Bone
Sponsor: Loyola University
Start date: 2016-06-15; Completion date: 2018-05-03
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether a patient with a tibial plateau fracture (non-displaced, displaced, or depression type) will have decreased pain and narcotic analgesia requirements following an intra-articular injection of local anesthetic and aspiration of the knee.

Detailed description:
We propose to study tibial plateau fractures treated at our institution for which we have fracture data, treated with open reduction internal fixation (ORIF) procedures or treated non-operatively. Patients will be identified based on the classification of their injury, that being tibial plateau fracture; we will seek to sub-classify each patient based on the Shatzker classification of tibial plateau fractures and using knee osteoarthritis (OA) classification as our prospective study will be based on both tibial plateau fractures as a whole and their sub-classification: Lateral tibial plateau fracture without depression (I), lateral tibial plateau fracture with depression (II), compression fracture of the lateral (IIIA) or central (IIIB) tibial plateau, medial tibial plateau fracture (IV), bicondylar tibial plateau fracture (V), and tibial plateau fracture with diaphyseal discontinuity (VI). It is important for our prospective study to classify each fracture pattern as they generally differ in energy of injury and thus may affect pain management or need for narcotic pain medications and also potentially affect functional outcomes.

Following consent for participation in the study, patients will be blinded to initial management of the tibial plateau fracture with either: Aspiration of the joint alone, aspiration of the knee joint and injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine, or no injection or aspiration therapy for a control arm. Using the block randomization list, the patient will be randomized at the time of consent for participation. For the sake of consistency, all participating treating physicians (orthopaedic on-call residents) will be trained on Sawbones Fully Encased Knee Joint with Patella and Ligaments for a standardized aspiration and injection technique.

For the patients randomized into the treatment arms, the knee will be held in 15-30 degrees short of full extension and fully prepped using chlorhexidine wipes in a centrifugal manner. An 18 gauge spinal needle will be introduced into the superolateral aspect of the knee (if the knee is too edematous, an inferolateral or inferomedial approach may be appropriate). We will aspirate the knee with a 60cc syringe until we are unable to draw out more fluid and record the volume on a case record form. Subsequently, we will remove the syringe from the needle connection, leaving the 18 gauge needle in place. Then we will draw up 30cc of 0.5% bupivacaine with 1:200,000 epinephrine (Marcaine) with .18-gauge needle into the second 60cc syringe. Subsequently, we will place the filled syringe on the 18 gauge needle already in the knee and inject. Then we will remove the needle-syringe construct and place a bandage over the injection site.

The patient's initial numerical rating scale (NRS) score will be recorded immediately. Subsequent visual analogue scale (VAS) scores will be recorded at 5 minutes after intervention and at hours 2, 4, 6, 8, 12, and 24 after initial work-up of the patient. Patients treated as an outpatient will record these values themselves. Patients will be directed to bring the completed form with them to their regular clinic follow-up visit. Additionally, supplemental analgesia requirements will be recorded upon administration and will be converted to morphine equivalent units for analysis. All patients admitted to the orthopedic service will be placed on patient-controlled analgesic (PCA) morphine, where the dose is determined by the weight of the patient. All other patients (those admitted to other services) will have analgesia converted to Opioid Morphine Equivalents (OMEs).

Arms: arm 1: Participants assigned to this arm receive aspiration of the joint alone in which a needle will be introduced into the knee joint to withdraw the blood that collects within the knee. arm 2: Participants assigned to this arm receive aspiration of the knee joint and an injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine arm 3: Participants assigned to this arm receive no injection or aspiration therapy.
Interventions: intervention 1: Aspiration intervention 2: Bupivacaine
Intervention descriptions: intervention 1: A needle is placed into the knee joint and all of the blood that is in the joint is removed. intervention 2: An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine

Protocol documents:
Prot_SAP_000.pdf: 
1 
 
LOYOLA UNIVERSITY CHICAGO 
HEALTH SCIENCES DIVISION 
MAYWOOD, ILLINOIS 
 
ORTHOPAEDIC SURGERY & REHABILITATION 
 
 
Project Title:  The effect of intra-articular local anesthetic injection and hematoma aspiration on 
pain and narcotic/opioid analgesia use following tibial plateau fractures 
 
LU#:  208755 
 
Annual Review II Date:  May 3, 2018 
 
Annual Review I Date: May 2, 2017 
 
Amendment I Ver II Date:  September 1, 2017 
 
Version I Date:   June 1, 2016 
 
Principal Investigator: William Lack, MD 
 
Research Team:  Hobie Summers, MD;; Joseph Cohen, MD On call Orthopaedic Residents, 
Cameron Killen, MD; Elizabeth Harkin, MD; Amy Ford, MD; Michael Perry, MD; Daniel 
Schmitt, MD; Eric Barnard, MD; Benjamin Davis, MD; Andrew Golz, MD; Mitchell Hughes, 
MD; Steven Ralles, MD; Nathan Finch, MS2; and Tammy Rhoda, MPH; Michael Murphy, MS3 
 
Inactive Research Team Member:  Mitchell Bernstein, MD 
 
Background  
The tibial plateau is one of the most complex load-bearing surfaces in the body, helping to 
account for alignment of the knee, knee mechanics, load sharing, and stability. Fractures of the 
tibial plateau can have devastating consequences, as they are often a result of high-energy falls or 
motor vehicle accidents with concomitant trauma to other areas of the body. Patients with 
osteoporotic bone or multiple severe medical co-morbidities are also at risk for fracture of the 
tibial plateau in low energy situations.  Most often, fractures occur as a result of combined axial 
loading with varus or valgus stress applied at the level of the tibial plateau.1-2 
 
Tibial plateau fractures are painful injuries, often requiring prolonged high doses of 
opioid/narcotic analgesia both pre-operatively and post-operatively. With the ever increasing 
attention being paid to the amount of narcotics prescribed to patients and the potential serious 
side effects associated with these medications, it is crucial to identify ways in our orthopaedic 
trauma population to decrease the use of narcotic pain medications while simultaneously 
improving patient outcomes and satisfaction.P2 
 


2 
 
There have been several studies examining the concept of injecting local anesthetics into joints 
that have dislocated, have associated intra-articular fractures, or have recently undergone 
operation.  We are unaware of any studies regarding the use of local anesthetics in the initial 
management of tibial plateau fractures, though there is extensive research regarding the use of 
local anesthetics or multimodal analgesia (MMA) in the knee joint following both total knee 
arthroplasty and arthroscopic knee surgery. Stein, et al examined the analgesic effect of intra-
articular morphine after arthroscopic knee surgery in a double-blinded study with 52 patients 
receiving one of four potential injections: 1mg morphine in knee and saline in iv, Saline in the 
knee and morphine in the IV, 0.5mg morphine in knee and 0.5mg morphine IV, 1mg morphine 
and 0.1mg naloxone intra-knee and IV. The pain scores were tested at 1,2,3,4,6,24hrs post-
operatively. It was determined that 1mg of morphine in the knee and saline in the IV had 
significantly lower pain scores at 2,3,4,6 hours and also had lower mean consumptions of 
supplemental analgesia than the other groups.P3
P This study shows that there pay be options other 
than simply locally active anesthetics in managing the pain associated with tibial plateau 
fractures acutely.  Busch et al took this study a step further, exploring the efficacy of periarticular 
multimodal drug injection in total knee arthroplasty.  The researchers used a mixture of 
ropivocaine (400mg), ketorolac (30mg), epimorphine (5mg) and epinephrine (0.6mL of 1:1000) 
and compared it to no injection in terms of Visual Analogue Pain Score (VAS) scoring at rest 
and with activity, in addition to PCA use post-operatively.  They showed that the injection arm 
had significantly less PCA use at 6 hrs, 12hrs, and 24 hrs; higher VAS for patient satisfaction 
and lower VAS for pain during activity in PACU and at 4 hours post-op.P4 
PThe importance of 
such a study is to illustrate that patient satisfaction was improved with MMA injection, in 
addition to decreased need for opioid analgesia post-operatively.  It is the goal of this research 
team to not only achieve anatomic reduction of a fractured tibial plateau but also to decrease 
post-operative opioid/narcotic analgesia and increase patient satisfaction.   
 
In choosing whether to use MMA, opioids or local anesthetic for injection into the knee 
following tibial plateau fractures, several studies have compared these in terms of pain reduction. 
Francheschi et al compared morphine and ropivocaine intra-articular injections following knee 
arthroscopy in terms of post-operative pain control. 90 patients were included in the study with 
procedures ranging from diagnostic scopes, lateral and medial meniscectomies, meniscal repairs, 
removal of loose bodies; all were performed under general anesthesia by the same surgeon. 3 
groups were randomized into injections of either 75 mg ropivcaine in 20mL solution, 2mg 
morphine in 20mL solution, or 20mL isotonic saline. A blind observer assessed post-operative 
pain using 10 cm VAS at 0,2,4,6,12,24 hours.  The study showed that VAS in the first 4 hours 
showed better efficacy in ropivocaine versus the morphine arm, but no difference in VAS existed 
at 24 hours.P5
P  Jauareguito et al compared morphine and bupivacaine intra-articularly for pain 
control after outpatient knee arthroscopy. Patients were given one of the following injections: 4 
mg morphine, 0.25% bupivacaine, or 0.9% saline. VAS scores and supplemental analgesia was 
recorded at 0,0.5, 2,4,6,8,12,24 hours post-operatively. The researchers found that the cumulative 
amount of pain medication used was significantly lower in the morphine and bupivacaine groups 
at 2 to 6 hours after surgery than in the saline control group, and the morphine group used the 
least supplemental pain medication during the 12 to 24 hour interval.P6
P Ropivocaine and 
Bupivocaine are both local anesthetics but are not identical.  
 


3 
 
White et al studied the use of intra-articular lidocaine vs. conscious sedation for the reduction 
and splinting of closed ankle fracture-dislocations demonstrating a similar degree of analgesia, 
which was significant enough to achieve adequate reduction without having to sedate a patient.P7 
PThis study demonstrates the adequacy of local anesthetics in terms of usefulness in peri or intra-
articular fracture management. The use of intra-articular lidocaine conveys less cardiopulmonary 
risks to the patient than conscious sedation.   
 
Other studies have used multimodal analgesia cocktails for injection into joints following 
operative management of a varity of pathologies. Perdreau et al used a combination of morphine, 
ropivacaine and methylprednisolone as an intra-articular injection following arthroscopic rotator 
cuff repair, with injection of isotonic saline as a control arm and measured pain intensity and 
post-operative morphine use at various post-operative time points. It was found that 
postoperative pain was significantly less intense in the MMA group than in controls at 30 min, 
H1, H4, H6, H12, H18 and H24 (17TP17T < 0.05). A rebound at D10 occurred in both groups. 
Additonally, during the first 24 hours, MMA significantly reduced cumulative resort to morphine 
(17TP17T < 0.05 at H1/2,0T 0T17TP17T < 0.001 at H1–24). The mean time to first bolus of morphine post-
operatively was significantly longer in the MMA group (71.6 vs. 33 min;0T 0T17TP17T < 0.05).P8 
 
One study conducted by Chalidis et al compared aspiration of the elbow joint versus aspiration 
with bupivacaine injection in the initial management of closed, non-displaced radial head 
fractures and failed to demonstrated a difference in terms of range of motion, pain and elbow 
function between the 2 groups in all the examined time points.P9 
PThis study, as it relates to our 
proposed research, aims to show that not all fractures are amenable to intra-articular anesthestic 
injections in terms of functional outcomes or reduction in narcotic analgesia use.  However, 
Ditsios et al studied the effect of hematoma aspiration of intra-articular pressure and pain relief 
following Mason I radial head fractures in 16 patients and demonstrated that there was a 
statistically significant decrease for both pressure in the elbow joint and pain (by VAS scoring) 
in patient’s who underwent aspiration compared to no aspiration.P10 
PThis study shows the 
potential for alleviation of pain and pressure in tibial plateau fractures as the knee is capable of 
holding much large volumes of blood than the elbow after a traumatic injury; the intra-articular 
pressure after a tibial plateau fracture may be one of the reasons the injury is so painful in the 
acute injury period. 
 
 
Rationale and Specific Aims  
 
The primary objective of this study is to determine whether a patient with a tibial plateau fracture 
(non-displaced, displaced, depression type) will have decreased pain and narcotic analgesia 
requirements following an intra-articular injection of local anesthetic and aspiration of the knee. 
In order to determine whether this institution has an appropriate volume of tibial plateau 
fractures to adequately perform such a trial, we have reviewed our volume of tibial plateau 
fractures and have determined we have an adequate volume to conduct such a study. The primary 
outcome of the study could potentially guide future management of tibial plateau fractures at this 
institution and potentially systemically.  


4 
 
a) Specific Aim 1: Examine the effect of hemarthrosis aspiration and intra-articular 
bupivacaine injection on recorded Numerical Rating Scale (NRS) pain scores for 
patients with tibial plateau fractures in the first 24 hours following injury. 
a. Working Hypothesis: Hemarthrosis aspiration and intra-articular bupivacaine 
injection will significantly decrease subjective pain scores in the early post-injury 
period.  
b. As stated previously, there has been substantial research to support the aspiration 
of fracture hematoma with intra-capsular injuries as it has been shown to decrease 
pain in the immediate presentation.  There has been no research regarding intra-
articular injection of local anesthetics in the acute setting of tibial plateau 
fractures, though there are several studies showing the efficacy of intra-articular 
anesthetics following total knee arthroplasty and various knee arthroscopic 
procedures involving the knee. There exist several methods for collecting 
subjective pain scores. One of the most common pain assessment tools, and the 
tool documented most in our institution is the VAS. To truly collect VAS data, 
one must use a 10cm or 100mm rule and have the patient point or state the area on 
the ruler than most appropriately depicts there current level of pain. The left most 
position represented by zero is “no pain” whereas the right most position, 
represented by 10cm or 100mm, is “maximal pain.”  However, this method is 
infrequently carried out in clinical practice and as such we have chosen to use a 
validated Numerical Rating Scale (NRS) for pain.  NRSs range from 0 to 10 and 
were validated for emergency department patients.P11
P One validation study 
demonstrated that the verbally administered NRS (0 representing “no pain” and 
10 representing “maximal, excruciating pain”) had a strong correlation with the 
VAS. This suggests that for patients who are asked to quantify their pain on a 
scale of 0-10 after tibial plateau fractures, the NRS is equivalent to using VAS 
pain scales but with easier reproducibility among varying clinical team members.   
 
b) 
UPreliminary studies 1.1:U Analgesic Effect of Intraarticular Bupivacaine or Morphine 
After Arthroscopic Knee Surgery: A Randomized, Prospective, Double-Blind Study. 
 
This study randomized patients undergoing arthroscopy of the knee into 3 arms: injection 
of normal saline (n=49), 0.25% bupivacaine (n=44), or 0.03% morphine (N=46) at the 
end of the procedure and VAS scores were recorded at times 3, 6, 12, and 24 hours post-
operatively.  The VAS data were analyzed 
using analysis of covariance (ANCOVA). 
VAS was analyzed only for treatment effect 
in this study.  Bupivacaine provided 
significant postoperative analgesia 
compared to morphine or saline (where no 
statistically significant difference was 
demonstrated).   Figure 1 demonstrates the 
VAS scores for the 3 arms of the study 
showing that the effect of Intra-articular 
bupivacaine was noted for all 24 hours of 
data collection.  Additionally, the study 
found that the time to first supplemental 


5 
 
analgesia was increased in both the morphine and bupivacaine arms compared to the 
placebo.P12 
 
 
c) Specific Aim 2: Determine if patients who undergo hemarthrosis aspiration of and 
intra-articular bupivacaine injection use less supplemental opioid analgesia. 
a. Working Hypothesis: Intra-articular aspiration and bupivacaine injection will 
significantly decrease the patients’ use of supplemental opioid analgesia in the 
early post-injury period. 
UPreliminary Studies 2.1:U Intra-Articular Injection of Bupivacaine in Knee-Replacement 
Operations: Results of Use for Analgesia and for Preemptive Blockade.  This study starts 
with a review of animal model research, stating that trauma to tissue and bone can lead to long-
lasting alterations with regard to pain perception by the central nervous system. Local anesthetics 
inhibit neural input to the CNS, which may inhibit or lessen the perception changes. The study 
had 3 arms: Group 1 received 30 ml 0.5% bupivacaine with 1:200,000 epinephrine prior to 
incision and 30ml saline after closure. Group 2 received 30ml of plain saline solution before the 
incision and 30mL of 0.5% bupivacaine and 1:200,000 epinephrine in saline solution after 
closure. The patients in Group 3 received 30mL of plain saline solution (a placebo) for both 
injections. The syringes were all prepared by the pharmacy in a double-blinded fashion. Pain 
scores were recorded at 1, 2, 4, 24 hours post-operative using the VAS scale. Each patient was 
placed on a patient-controlled analgesia (PCA) pump with morphine as the analgesic, and dosing 
was recorded for 24 hours.  RESULTS: The study found tht the patient who received bupivacaine 
after closure of the wound had lower mean VAS scores during the 24 hour study periof, though it 
was not statistically significant. However the need for supplemental analgesia (morphine via 
PCA) in the post wound closure bupivacaine group was significantly lower than the placebo or 
preemptive blockade. The finding that post-trauma (post-operative) bupivacaine was more 
beneficial than preemptive analgesia or placebo actually bolsters our study hypothesis, that post-
traumatic intra-articular bupivacaine will result in decreased need for supplemental narcotic 
medication.P13 
 
Inclusion/Exclusion Criteria  
 
We will enroll patients based on eligibility for the study.   
 
Inclusion Criteria:  
 Patients with isolated tibial plateau fractures aged 18 years and older.  
 Patients with tibial plateau fractures and associated soft tissue complaints about the knee, 
not associated with a fracture outside of the tibial plateau 
 Patients with bilateral tibial plateau fractures and no other noted fractures 
 
Exclusion Criteria:  
 Any Patient that does not wish to participate in the study or is unable to give consent at 
the initial encounter will be excluded.  
 Patients under 18 years old 
 Pregnant patients 
 Mentally handicapped patients who are unable to give consent 


6 
 
 Incarcerated patients 
 Inability or unwillingness to consent for participation 
 History of allergic reaction to local anesthetics 
 Emergent conditions requiring operations or airway protection 
 Polytrauma patients 
 Patients presenting for care > 24 hours following their injury.  
 
 
Enrollment/Randomization  
 
Sample sizes of 22, 22, and 22 will be allocated to 3 groups (control, aspiration, and aspiration 
plus injection) using an equal 1:1:1 block randomized allocation.  
 
Study Procedures  
 
We propose to study all tibial plateau fractures treated at LUHS for which we have 
fracture data, treated with ORIF or treated non-operatively. Patients will be identified based on 
the classification of their injury, that being tibial plateau fracture; we will seek to sub-classify 
each patient based on the Shatzker classification of tibial plateau fractures and using OA 
classification as our prospective study will be based on both tibial plateau fractures as a whole 
and their sub-classification: lateral tibial plateau fracture without depression (I), lateral tibial 
plateau fracture with depression (II), compression fracture of the lateral (IIIA) or central (IIIB) 
tibial plateau, medial tibial plateau fracture (IV), bicondylar tibial plateau fracture (V), and tibial 
plateau fracture with diaphyseal discontinuity (VI).2  It is important for our prospective study to 
classify each fracture pattern as they generally differ in energy of injury and thus may affect pain 
management or need for narcotic pain medications and also potentially affect functional 
outcomes.  Patient inclusion will be based on agreement to participate using informed consent. 
Additionally, patients may be excluded from the study if they choose not to consent, are 
incapacitated on initial presentation, have an emergent condition necessitating either operative 
management or airway protection or have a history of allergic reaction to local anesthetic 
injection. 
 
Following consent for participation in the study, patients will be blinded to initial 
management of the tibial plateau fracture with either: Aspiration of the joint alone, aspiration of 
the knee joint and injection of 20cc bupivacaine 0.5% with 1:200,000 epinephrine or no injection 
or aspiration therapy for a control arm. Using the block randomization list, the patient will be 
randomization at the time of consent for participation. For the sake of consistency, all 
participating treating physicians (orthopaedic on-call residents) will be trained on Sawbones™ 
Fully Encased Knee Joint with Patella and Ligaments for a standardized aspiration and injection 
technique.  
 
For the patients randomized into the treatment arms, the knee will be held in 15-30* short 
of full extension and fully prepped using chlorhexadine wipes in a centrifugal manner. An 18 
gauge spinal needle will be introduced into the superolateral aspect of the knee (if the knee is too 
edematous, an inferolateral or inferomedial approach is appropriate, but requires documentation). 
Aspirate the knee with 60cc syringe until unable to draw out more fluid and record volume on 


7 
 
given study form. Remove the syringe from the needle connection, leaving the 18 gauge needle 
in place. Draw up 30cc of 0.5% bupivacaine with 1:200,000 epinephrine (Marcaine) with .18-
gauge needle into 2nd 60cc syringe. Place the filled syringe on the 18 gauge needle already in the 
knee and INJECT. Remove needle-syringe construct and place bandage over injection site.  
 
The patient’s initial NRS score will be recorded immediately. Subsequent VAS scores 
will be recorded at time points 0 (5 minutes after intervention), 2, 4, 6, 8, 12, 24 hours after 
initial work-up of the patient. Patients treated as an outpatient will record these values 
themselves (copy of recording form submitted with this application).  Patients will be directed to 
bring the completed form with them to their regular clinic follow-up visit.  Additionally, 
supplemental analgesia requirements will be recorded upon administration and will be converted 
to morphine equivalent units for analysis (copy of recording form submitted with this 
application).  All patients admitted to the orthopedic service will be placed on morphine PCA 
(determined dosing by weight of patient). All other patients (those admitted to other services) 
will have analgesia converted to Opioid Morphine Equivalents (OMEs).  
 
Prospectively: Patients will be blinded to initial management of the tibial plateau fracture 
with either: Aspiration of the knee joint alone, aspiration of the joint and injection of bupivacaine 
0.5% with epinephrine or no injection or aspiration therapy for a control arm. Using the block 
randomization list, the patient will be randomization at the time of consent for participation. The 
patient’s initial VAS score will be recorded at the time of initial work-up. Subsequent VAS 
scores will be recorded at time points 2, 4, 6, 8, 12, 24 hours after initial work-up of the patient. 
Additionally, supplemental analgesia requirements will be recorded upon administration and will 
be converted to morphine equivalent units for analysis. 
 
Demographic information to be collected includes Age, BMI, Problem list: Medications, 
Allergies, Smoker, Alcohol and Drug use. 
 
Risks  
 
Risks associated with aspiration of the knee joint include: 
 Pain 
 Infection 
 Inability to remove any fluid or blood from the joint 
 The need to attempt another needle stick to place the needle in the correct position 
 
Risks associated with injection of a local anesthetic in the joint include: 
 Pain 
 Infection 
 Chondrolysis reported in vitro with bovine cartilage; no human studies support this 
finding. 
 There have been no reported incidences of systemic issues associated with a single intra-
articular knee injection of any local anesthetic  
 
Reporting of Adverse Events or Unanticipated Problems involving Risk to Participants or 
Others  


8 
 
 
Adverse event identification will be the responsibility of each member of the research team 
and to report same to one of the trauma surgeons, William Lack, MD; Hobie Summers, MD; 
and Mitchell Bernstein, MD.  Specifically, Dr. William Lack will be responsible for 
reporting promptly to the IRB office. 
 
Study Withdrawal/Discontinuation  
 
If at any time during the course of the patient’s treatment or data collection, the patient decides to 
withdraw from the study they may do so without any consequence. If the patient decides to 
withdraw after consent is given they may do so and will not be included in the study.   
 
Statistical Considerations  
 
Sample sizes of 22, 22, and 22 will be allocated to 3 groups (control, aspiration, and aspiration 
plus injection) using an equal 1:1:1 block randomized allocation.  The null hypothesis is that at 
24 hours the mean VAS score for these three groups will be equivalent.  Power is computed to 
reject this null hypothesis.  A total sample of 66 subjects achieves 84% power to detect at least 
one pairwise minimal difference score of 1.60mm using the Tukey-Kramer (Pairwise) multiple 
comparison test at a 0.05 significance level. An assumption was made to set the common 
standard deviation of the VAS score within any one group to 1.00mm. 
 
Privacy/Confidentiality Issues  
 
The principal investigator and research team members listed on the protocol will have access to 
protected health information.   
 
All patient health information (PHI), demographics and sensitive data will be kept on the Loyola 
provided secure server in an assigned password protected folder located on the R: drive and/or in 
a REDCap database.  All paper records, if any, will be kept in a locked cabinet in the offices of 
the principal investigator.  
 
Follow-up and Record Retention  
 
All records will be removed from secure server upon completion of the study.  All paper records, 
if any, will be disposed of using Loyola approved system and receptacles. 
 
Bibliography: 
1. Manidakis, Nikolaos, Anis Dosani, Rozalia Dimitriou, Dirk Stengel, Stuart Matthews, and 
Peter Giannoudis. "Tibial Plateau Fractures: Functional Outcome and Incidence of Osteoarthritis 
in 125 Cases." International Orthopaedics (SICOT) International Orthopaedics 34.4 (2009): 
565-70. Web. 


9 
 
2. Koval, KJ, and DL Helfet. "Tibial Plateau Fractures: Evaluation and Treatment." J Am Acad 
Orthop Surg. 3.2 (1995): 86-94. PubMed. Web. 
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Peter. "Analgesic Effect of Intra-articular Morphine after Arthroscopic Knee Surgery." New 
England Journal of Medicine N Engl J Med 325.16 (1991): 1123-126. Web. 
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9. Chalidis, Byron E., Pericles P. Papadopoulos, Nick C. Sachinis, and Christos G. Dimitriou. 
"Aspiration Alone versus Aspiration and Bupivacaine Injection in the Treatment of Undisplaced 
Radial Head Fractures: A Prospective Randomized Study." Journal of Shoulder and Elbow 
Surgery 18.5 (2009): 676-79. Web. 


10 
 
10. Ditsios, Konstantinos T., Stavros I. Stavridis, and Anastasios G. Christodoulou. "The Effect 
of Haematoma Aspiration on Intra-articular Pressure and Pain Relief following Mason I Radial 
Head Fractures." Injury 42.4 (2011): 362-65. Web. 
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intraarticular bupivacaine or morphine after arthroscopic knee surgery: a randomized, 
prospective, double-blind study. Anesthesia & Analgesia. 1992;74(6):822-6. 
13. Badner NH, Bourne RB, Rorabeck CH, MacDonald SJ, Doyle JA. Intra-articular injection 
of bupivacaine in knee-replacement operations. Results of use for analgesia and for 
preemptive blockade. J Bone Joint Surg Am. 1996 May;78(5):734-8.