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Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_9 | Pages 103 - 103
1 May 2017
Kaya A Ömer Ü Oğuz PŞ Bahattin K Samet E Burak Ö
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Background. Osteoarthritis (OA) pain treatment has limitations in terms of serious adverse effects and low efficacy. We aimed to evaluate efficacy and safety of naproxen sodium/codeine phosphate combination in these patients. Methods. In this prospective, randomised, double blind, placebo controlled clinical trial, 135 patients with osteoarthritis, who were 40–65 years; applied to our institution's orthopaedics outpatient clinic; had grade 1, 2, or 3 primary osteoarthritis diagnosed in last 1 year; and had Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score≥40, and Visual Analogue Scale score≥40, were enrolled. Subjects were randomised (1:1) to placebo (n= 67) or combination (n= 68) arms, in which 550 mg naproxen sodium/30mg codeine phosphate was given orally twice a day for 7 days. Rescue medicine was 500 mg paracetamol (max= 6 tablets/day). Demographic characteristics, medical history, adverse events, VAS and WOMAC scores were collected in study visits performed within 10 days. The study was approved by local institutional ethics committee and written informed consents were obtained from all participants. Results. Patients were evenly matched in both arms. The mean age was 52.3±6.6 years (89.7% female). WOMAC and VAS scores decreased significantly within each group (p<0.001 for all). For the study group (n=43) the mean (+ SD) and median (min-max) VAS Score was −29.8 (+21.0) and −30 (−70−0), respectively. In contrast, for the control group (n=36) the mean and median (min-max) VAS Score was −16.1 (+24.4) and −12.5 (−65−40), respectively. WOMAC score was decreased more in combination group (p= 0.044). Changes in VAS scores between visits were significantly different (more in combination receivers) between groups (p= 0.018). Ratio of patients requiring no rescue medicine was higher among combination receivers than controls (64.8% vs. 35.2%, respectively). Most common adverse events were constipation, dyspepsia, and somnolence; no fatality was encountered. Conclusions. Naproxen sodium/codeine phosphate combination is effective and safe in osteoarthritis patients. Level of Evidence. Level 1


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_II | Pages 279 - 279
1 May 2010
Moghtadaei M Akbarian E Farahini H Zangi M Pazouki M
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Background: Polymethylmethacrylate (PMMA) is a potent stimulant of inflammatory response. This study investigated the role of Prostaglandin E2 (PGE2), Platelet activating factor (PAF) and histamine and their specific antagonists in bone changes. Materials: 120 white-male-wistar rats were divided into ten groups. Using sterile technique, a 2mm drill hole was made in the tibia 1cm distal to the knee joint bilaterally. The left tibia was filled with Simplex particulate cement polymer (PMMA) and the right tibia was used as control. The first nine groups respectively received terfenadine 1mg/kg, 10mg/kg and 25mg/kg, alprazolam 0.08mg/kg, 0.32mg/kg and 0.64mg/kg, and naproxen 1mg/kg, 5mg/kg and 25mg/kg; however, the tenth group received no drug and served as control. The animals were killed after 16 weeks and implant areas were harvested aseptically and studied by one pathologist. Results: Our study revealed that the cellular reaction in the left side was statistically more than the right one in all cases (p< 0.05). Also, a significant decrease in histiocytes and giant cells was seen just in those groups that had received 10mg/kg and 25mg/kg of terfenadine, 0.32mg/kg and 0.64mg/kg of alprazolam and 5mg/kg and 25mg/kg of naproxen (P< 0.05) while administration of 1mg/kg naproxen resulted in significant decrease only in giant cells (P< 0.05) but not in histiocytes. Discussion: Previous studies have suggested that particulate debris, PGE2 production and inflammatory response are associated with arthroplasty loosening. This experiment has demonstrated that the increased cellular reaction by the membrane surrounding particulate cement polymer can be suppressed by administration of PGE2, PAF and histamine specific inhibitors. The use of these agents may be indicated in retarding the bone loss associated with early prosthetic loosening


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Hallux valgus surgery can result in moderate to severe post-operative pain requiring the use of narcotic medication. The percutaneous distal metatarsal osteotomy is a minimally invasive approach which offers many advantages including minimal scarring, immediate weight bearing and decreased post-operative pain. The goal of this study is to determine whether the use of narcotics can be eliminated using an approach combining multimodal analgesia, ankle block anesthesia and a minimally invasive surgical approach. Following ethics board approval, a total of 160 ambulatory patients between the ages of 18-70 with BMI ≤ 40 undergoing percutaneous hallux valgus surgery are to be recruited and randomized into Narcotic-free (NF) or Standard (S) groups. To date, 72 patients have been recruited (38 NF and 34 S). The NF group received acetaminophen, naproxen, pregabalin 75mg and 100mg Ralivia (tramadol extended release) before surgery and acetaminophen, naproxen, pregabalin 150mg one dose and Ralivia 100mg BID for five days, as well as a rescue narcotic (hydromorphone, 1mg pills) after surgery. The S group received acetaminophen and naproxen prior to surgery and acetaminophen, naproxen and hydromorphone (1mg pills) post-operatively, our current standard. Visual analog scales (VAS) were used to assess pain and narcotic consumption was recorded at 6, 12, 24, 36, 48, 72 hours and seven days post-operatively. Patients wore a smart watch to record the number of daily steps and sleep hours. A two-sided t-test was used to compare the VAS scores and narcotic consumption. During the first post-operative week, the NF group consumed in total an average of 6.5 pills while the S group consumed in total an average of 16 pills and this difference was statistically significant (p-value=0.001). Importantly, 19 patients (50%) in the NF group and four patients (12%) in the S group did not consume any narcotics post-operatively. For the VAS scores at 24, 48, 72 hours and seven days the NF group's average scores were 2.17, 3.17, 2.92, 2.06 respectively and the S group's average scores were 3.97, 4.2, 3.23, 1.97. There was a statistically significant difference between the groups at 24 and 48hours (the NF group scored lower on the VAS) with a p-value of 0.0008 and 0.04 respectively, but this difference is not considered clinically significant as the minimal clinically important difference reported in the literature is a two-point differential. The NF group walked an average of 1985.75 steps/day and slept an average of 8h01 minute/night, while the S group walked an average of 1898.26 steps/day and slept an average of 8h26 minutes/night in the first post-operative week. Hallux valgus remains a common orthopedic foot problem for which surgical treatment results in moderate to severe post-operative pain. This study demonstrates that with the use of multimodal analgesia, ultrasound guided ankle blocks and a percutaneous surgical technique, narcotic requirements decreased post-operatively. The use of long-acting tramadol further decreased the need for narcotic consumption. Despite decreased use of narcotics, this combined novel approach to hallux valgus surgery allows for early mobilization and excellent pain control


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_12 | Pages 65 - 65
1 Dec 2022
Gazendam A Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups. As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X). The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_13 | Pages 71 - 71
1 Dec 2022
Gazendam A Ekhtiari S Ayeni OR
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Orthopaedic surgeons prescribe more opioids than any other surgical speciality. Opioids remain the analgesic of choice following arthroscopic knee and shoulder surgery. There is growing evidence that opioid-sparing protocols may reduce postoperative opioid consumption while adequately addressing patients’ pain. However, there are a lack of prospective, comparative trials evaluating their effectiveness. The objective of the current randomized controlled trial (RCT) was to evaluate the efficacy of a multi-modal, opioid-sparing approach to postoperative pain management in patients undergoing arthroscopic shoulder and knee surgery. The NO PAin trial is a pragmatic, definitive RCT (NCT04566250) enrolling 200 adult patients undergoing outpatient shoulder or knee arthroscopy. Patients are randomly assigned in a 1:1 ratio to an opioid-sparing group or standard of care. The opioid-sparing group receives a three-pronged prescription package consisting of 1) a non-opioid prescription: naproxen, acetaminophen and pantoprazole, 2) a limited opioid “rescue prescription” of hydromorphone, and 3) a patient education infographic. The control group is the current standard of care as per the treating surgeon, which consists of an opioid analgesic. The primary outcome of interest is oral morphine equivalent (OME) consumption up to 6 weeks postoperatively. The secondary outcomes are postoperative pain scores, patient satisfaction, quantity of OMEs prescribed and number of opioid refills. Patients are followed at both 2 and 6 weeks postoperatively. Data analysts and outcome assessors are blinded to the treatment groups. As of December 1, 2021 we have enrolled 166 patients, reaching 83% of target enrolment. Based on the current recruitment rate, we anticipate that enrolment will be completed by the end of January 2022 with final follow-up and study close out completed by March of 2022. The final results will be released at the Canadian Orthopaedic Association Meeting in June 2022 and be presented as follows. The mean difference in OME consumption was XX (95%CI: YY-YY, p=X). The mean difference in OMEs prescribed was XX (95%CI: YY-YY, p=X). The mean difference in Visual Analogue Pain Scores (VAS) and patient satisfaction are XX (95%CI: YY-YY, p=X). The absolute difference in opioid refills was XX (95%CI: YY-YY, p=X). The results of the current study will demonstrate whether an opioid sparing approach to postoperative outpatient pain management is effective at reducing opioid consumption while adequately addressing postoperative pain in patients undergoing outpatient shoulder and knee arthroscopy. This study is novel in the field of arthroscopic surgery, and its results will help to guide appropriate postoperative analgesic management following these widely performed procedures


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 17 - 17
1 Jun 2016
Saed A Aweid O Kalairajah Y
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Introduction. The mortality and serious side effects risk of both medical and surgical management of hip and knee osteoarthritis (OA) has been widely published. To date however, there are no studies comparing safety between the two treatment modalities. We aimed to systematically review the published evidence on the mortality and serious complications risk of the various treatments for hip and knee OA. Methods. We searched for studies investigating the safety of arthroplasty, arthroscopy, opioids, non-steroidal anti-inflammatory drugs (NSAIDS), and paracetamol using PubMed, Score, Cochrane, PEDRO, and Google Scholar. The phrase “osteoarthritis treatment” was searched and then combined using Boolean connectors (“OR and “AND) with “serious complications” or “serious adverse events” or “mortality”. The quality of included studies was assessed based on the approach used by the AAOS in judging the quality of treatment studies. Results. 19 studies were included in the review. Mortality risk was highest for Naproxen HR = 3 (1.9; 4.6) and lowest for total hip replacement RR = 0.7 (0.7; 0.7). Highest serious gastrointestinal complication risk was reported for diclofenac OR = 4.77 (3.94; 5.76) and lowest for total knee replacement HR = 0.6 (0.49; 0.75). Ibuprofen had the highest renal complications risk OR=2.32 (1.45; 3.71) whereas celecoxib had the lowest RR = 0.61 (0.4; 0.94). Celecoxib users had the highest cardiovascular (CV) complication risk OR=2.26 (1; 5.1) and the lowest was for tramadol RR = 1.1 (0.87; 1.4). Discussion. Long term medical management of hip and knee OA particularly with NSAIDS may carry a higher mortality risk compared to surgery. Conclusion. The practitioner and patient should carefully consider the risks of medications as well as surgery prior to commencing treatment. Treatment choice should also be tailored to the patient taking into account known GI, CVS, and renal co-morbidities


Bone & Joint 360
Vol. 12, Issue 1 | Pages 30 - 33
1 Feb 2023

The February 2023 Shoulder & Elbow Roundup360 looks at: Arthroscopic capsular release or manipulation under anaesthesia for frozen shoulder?; Distal biceps repair through a single incision?; Distal biceps tendon ruptures: diagnostic strategy through physical examination; Postoperative multimodal opioid-sparing protocol vs standard opioid prescribing after knee or shoulder arthroscopy: a randomized clinical trial; Graft healing is more important than graft technique in massive rotator cuff tear; Subscapularis tenotomy versus peel after anatomic shoulder arthroplasty; Previous rotator cuff repair increases the risk of revision surgery for periprosthetic joint infection after reverse shoulder arthroplasty; Conservative versus operative treatment of acromial and scapular spine fractures following reverse total shoulder arthroplasty.


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1244 - 1251
1 Dec 2023
Plastow R Raj RD Fontalis A Haddad FS

Injuries to the quadriceps muscle group are common in athletes performing high-speed running and kicking sports. The complex anatomy of the rectus femoris puts it at greatest risk of injury. There is variability in prognosis in the literature, with reinjury rates as high as 67% in the severe graded proximal tear. Studies have highlighted that athletes can reinjure after nonoperative management, and some benefit may be derived from surgical repair to restore function and return to sport (RTS). This injury is potentially career-threatening in the elite-level athlete, and we aim to highlight the key recent literature on interventions to restore strength and function to allow early RTS while reducing the risk of injury recurrence. This article reviews the optimal diagnostic strategies and classification of quadriceps injuries. We highlight the unique anatomy of each injury on MRI and the outcomes of both nonoperative and operative treatment, providing an evidence-based management framework for athletes.

Cite this article: Bone Joint J 2023;105-B(12):1244–1251.


The Bone & Joint Journal
Vol. 100-B, Issue 7 | Pages 915 - 922
1 Jul 2018
Joice M Vasileiadis GI Amanatullah DF

Aims

The aim of this study was to assess the efficacy of non-selective and selective non-steroidal anti-inflammatory drugs (NSAIDs) in preventing heterotopic ossification (HO) after total hip arthroplasty (THA).

Methods

A thorough and systematic literature search was conducted and 29 studies were found that met inclusion criteria. Data were extracted and statistical analysis was carried out generating forest plots.


The Bone & Joint Journal
Vol. 99-B, Issue 11 | Pages 1420 - 1430
1 Nov 2017
Azboy I Barrack R Thomas AM Haddad FS Parvizi J

The number of arthroplasties being performed increases each year. Patients undergoing an arthroplasty are at risk of venous thromboembolism (VTE) and appropriate prophylaxis has been recommended. However, the optimal protocol and the best agent to minimise VTE under these circumstances are not known. Although many agents may be used, there is a difference in their efficacy and the risk of bleeding. Thus, the selection of a particular agent relies on the balance between the desire to minimise VTE and the attempt to reduce the risk of bleeding, with its undesirable, and occasionally fatal, consequences.

Acetylsalicylic acid (aspirin) is an agent for VTE prophylaxis following arthroplasty. Many studies have shown its efficacy in minimising VTE under these circumstances. It is inexpensive and well-tolerated, and its use does not require routine blood tests. It is also a ‘milder’ agent and unlikely to result in haematoma formation, which may increase both the risk of infection and the need for further surgery. Aspirin is also unlikely to result in persistent wound drainage, which has been shown to be associated with the use of agents such as low-molecular-weight heparin (LMWH) and other more aggressive agents.

The main objective of this review was to summarise the current evidence relating to the efficacy of aspirin as a VTE prophylaxis following arthroplasty, and to address some of the common questions about its use.

There is convincing evidence that, taking all factors into account, aspirin is an effective, inexpensive, and safe form of VTE following arthroplasty in patients without a major risk factor for VTE, such as previous VTE.

Cite this article: Bone Joint J 2017;99-B:1420–30.


Bone & Joint 360
Vol. 5, Issue 1 | Pages 23 - 24
1 Feb 2016


The Bone & Joint Journal
Vol. 98-B, Issue 6 | Pages 761 - 766
1 Jun 2016
Davis G Patel RP Tan TL Alijanipour P Naik TU Parvizi J

Aims

We aimed to assess the influence of ethnicity on the incidence of heterotopic ossification (HO) after total hip arthroplasty (THA).

Patients and Methods

We studied the six-month post-operative anteroposterior radiographs of 1449 consecutive primary THAs (1324 patients) and retrospectively graded them for the presence of HO, using the Brooker Classification.


The Bone & Joint Journal
Vol. 99-B, Issue 4 | Pages 483 - 488
1 Apr 2017
Pinsornsak P Nangnual S Boontanapibul K

Aims

Multimodal infiltration of local anaesthetic provides effective control of pain in patients undergoing total knee arthroplasty (TKA). There is little information about the added benefits of posterior capsular infiltration (PCI) using different combinations of local anaesthetic agents. Our aim was to investigate the effectiveness of the control of pain using multimodal infiltration with and without infiltration of the posterior capsule of the knee.

Patients and Methods

In a double-blind, randomised controlled trial of patients scheduled for unilateral primary TKA, 86 were assigned to be treated with multimodal infiltration with (Group I) or without (Group II) PCI. Routine associated analgesia included the use of bupivacaine, morphine, ketorolac and epinephrine. All patients had spinal anaesthesia and patient-controlled analgesia (PCA) post-operatively. A visual analogue scale (VAS) for pain and the use of morphine were recorded 24 hours post-operatively. Side effects of the infiltration, blood loss, and length of stay in hospital were recorded.


Bone & Joint Research
Vol. 1, Issue 7 | Pages 131 - 144
1 Jul 2012
Papavasiliou AV Bardakos NV

Over recent years hip arthroscopic surgery has evolved into one of the most rapidly expanding fields in orthopaedic surgery. Complications are largely transient and incidences between 0.5% and 6.4% have been reported. However, major complications can and do occur. This article analyses the reported complications and makes recommendations based on the literature review and personal experience on how to minimise them.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 10 | Pages 1380 - 1381
1 Oct 2008
Patel A Calfee R Thakur N Eberson C

Iliacus haematoma is a relatively rare condition, which may cause a local compressive neuropathy. It is usually diagnosed in adults with haemophilia or those on anticoagulation treatment and may occur after trauma. We present the case of a healthy 15-year-old boy with a femoral neuropathy due to an iliacus haematoma which resolved following conservative treatment.


The Bone & Joint Journal
Vol. 96-B, Issue 11_Supple_A | Pages 27 - 31
1 Nov 2014
Kraay MJ Bigach SD

Degenerative problems of the hip in patients with childhood and adult onset neuromuscular disorders can be challenging to treat. Many orthopaedic surgeons are reluctant to recommend total hip replacement (THR) for patients with underlying neuromuscular disorders due to the perceived increased risks of dislocation, implant loosening, and lack of information about the functional outcomes and potential benefits of these procedures in these patients. Modular femoral components and alternative bearings which facilitate the use of large femoral heads, constrained acetabular components and perhaps more importantly, a better understanding about the complications and outcomes of THR in the patient with neuromuscular disorders, make this option viable. This paper will review the current literature and our experience with THR in the more frequently encountered neuromuscular disorders.

Cite this article: Bone Joint J 2014;96-B(11 Suppl A):27–31.


Bone & Joint 360
Vol. 3, Issue 3 | Pages 16 - 18
1 Jun 2014

The June 2014 Hip & Pelvis Roundup360 looks at: Modular femoral necks: early signs are not good; is corrosion to blame for modular neck failures; metal-on-metal is not quite a closed book; no excess failures in fixation of displaced femoral neck fractures; noise no problem in hip replacement; heterotopic ossification after hip arthroscopy: are NSAIDs the answer?; thrombotic and bleeding events surprisingly low in total joint replacement; and the elephant in the room: complications and surgical volume.


The Bone & Joint Journal
Vol. 95-B, Issue 11 | Pages 1490 - 1496
1 Nov 2013
Ong P Pua Y

Early and accurate prediction of hospital length-of-stay (LOS) in patients undergoing knee replacement is important for economic and operational reasons. Few studies have systematically developed a multivariable model to predict LOS. We performed a retrospective cohort study of 1609 patients aged ≥ 50 years who underwent elective, primary total or unicompartmental knee replacements. Pre-operative candidate predictors included patient demographics, knee function, self-reported measures, surgical factors and discharge plans. In order to develop the model, multivariable regression with bootstrap internal validation was used. The median LOS for the sample was four days (interquartile range 4 to 5). Statistically significant predictors of longer stay included older age, greater number of comorbidities, less knee flexion range of movement, frequent feelings of being down and depressed, greater walking aid support required, total (versus unicompartmental) knee replacement, bilateral surgery, low-volume surgeon, absence of carer at home, and expectation to receive step-down care. For ease of use, these ten variables were used to construct a nomogram-based prediction model which showed adequate predictive accuracy (optimism-corrected R2 = 0.32) and calibration. If externally validated, a prediction model using easily and routinely obtained pre-operative measures may be used to predict absolute LOS in patients following knee replacement and help to better manage these patients.

Cite this article: Bone Joint J 2013;95-B:1490–6.


The Bone & Joint Journal
Vol. 96-B, Issue 1 | Pages 24 - 30
1 Jan 2014
Haddad B Konan S Haddad FS

We have reviewed the current literature to compare the results of surgery aimed to repair or debride a damaged acetabular labrum. We identified 28 studies to be included in the review containing a total of 1631 hips in 1609 patients. Of these studies 12 reported a mean rate of good results of 82% (from 67% to 100%) for labral debridement. Of the 16 studies that reported a combination of debridement and re-attachment, five reported a comparative outcome for the two methods, four reported better results with re-attachment and one study did not find any significant difference in outcomes. Due to the heterogeneity of the studies it was not possible to perform a meta-analysis or draw accurate conclusions. Confounding factors in the studies include selection bias, use of historical controls and high rates of loss of follow-up.

It seems logical to repair an unstable tear in a good quality labrum with good potential to heal in order potentially to preserve its physiological function. A degenerative labrum on the other hand may be the source of discomfort and its preservation may result in persistent pain and the added risk of failure of re-attachment. The results of the present study do not support routine refixation for all labral tears.

Cite this article: Bone Joint J 2014;96-B:24–30.


Objectives

Local corticosteroid infiltration is a common practice of treatment for lateral epicondylitis. In recent studies no statistically significant or clinically relevant results in favour of corticosteroid injections were found. The injection of autologous blood has been reported to be effective for both intermediate and long-term outcomes. It is hypothesised that blood contains growth factors, which induce the healing cascade.

Methods

A total of 60 patients were included in this prospective randomised study: 30 patients received 2 ml autologous blood drawn from contralateral upper limb vein + 1 ml 0.5% bupivacaine, and 30 patients received 2 ml local corticosteroid + 1 ml 0.5% bupivacaine at the lateral epicondyle. Outcome was measured using a pain score and Nirschl staging of lateral epicondylitis. Follow-up was continued for total of six months, with assessment at one week, four weeks, 12 weeks and six months.