Research Study Summaries (Complete) Flashcards
FLOW trial
“A Trial of Wound Irrigation in the Initial Management of Open Fracture Wounds”
N Engl J Med 2015;373:2629-41.
Results
- When using high, low and very-low pressure for irrigation in the management of open fractures of the extremities, there was no significant difference in:
- Reoperation rate due to infection
- Management of wound-healing issues
- Bone-healing issues
- Additionally, irrigation with saline solution demonstrated a significantly lower composite reoperation rate compared to castile soap solution
Take home
- Very low pressure irrigation of open fractures is a viable, low-cost alternative to low or high pressure irrigation
- Saline solution may be advantageous over castile soap solution in the irrigation of open fractures
- Further evaluation of fracture types, such as tibial fractures, where certain irrigation pressures may provide advantage merit further investigation
FAITH trial
“Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial”
Lancet. 2017 Apr 15;389(10078):1519-1527
Results
- SHS vs Cancellous screws for hip fracture ORIF
- No significant difference in overall reoperation rate
Take home
- The reason or result of reoperation following fixation of hip fractures may differ between SHS and cancellous screws, but the overall rate of reoperation with the first 24 months does not differ between techniques
- Of important note, the overall incidence of AVN was higher with SHS
- In contrast, subgroup analysis suggested that specific patient groups may have a lower risk of subsequent reoperation with a sliding hip screw
- Displaced fractures
- Current smokers
- Basicervical fractures
- Overall, the choice between either SHS or cancellous screws for fixation of a hip fracture appears a matter of discretion for surgeons and patients, with no clear advantage or disadvantage of either choice apparent from the most recent data
SPRINT trial
“Randomized Trial of Reamed and Unreamed Intramedullary Nailing of Tibial Shaft Fractures”
J Bone Joint Surg Am. 2008 Dec;90(12):2567-78
Results
- This study supported the use of reamed IM nailing as a treatment for closed tibial shaft fractures
- Reamed nailing resulted in fewer dynamizations and autodynamizations
- Uncertainty remains regarding the best nailing technique for open fracture treatment
Take Home
- The use of a reamed IM nailing procedure appears to provide the best outcomes for patients with closed tibial fractures
- However, there is still controversy regarding the optimal IM nailing treatment for patients with open tibial shaft fractures
SPRINT trial - Multivariable logistic regression analysis
“Prognostic Factors for Predicting Outcomes After Intramedullary Nailing of the Tibia”
J Bone Joint Surg Am. 2012 Oct 3; 94(19): 1786–1793
Results
- Increased risk of negative events in patients with:
- High-energy mechanism of injury
- Stainless steel compared with a titanium nail
- Fracture gap
- <1 cm compared with no fracture gap
- Full weight-bearing status after surgery
- Increased risk associated with weight-bearing and nail material was attributable to the autodynamization component
- Open Fractures
- Higher risk of events among patients treated with reamed nailing but not in patients treated with unreamed nailing
- Primary closure or delayed primary closure had decreased risk of an event compared with patients requiring additional soft-tissue reconstruction
- No increased risk with:
- Use of NSAIDs
- Late or early time to surgery
- Smoking status
Achilles trial
“Operative versus nonoperative treatment of acute Achilles tendon ruptures: a multicenter randomized trial using accelerated functional rehabilitation”
J Bone Joint Surg Am. 2010 Dec 1;92(17):2767-75.
Results
- Nonoperative treatment followed by an accelerated functional rehabilitation program is an effective treatment for acute Achilles tendon rupture
- Similar functional outcomes to operative treatment without the addition of surgical complications
- Operative treatment resulted in 10% more complications than nonoperative treatments
- Specifically soft tissue damage such as:
- Infection
- Pulmonary embolus
- Wound complications
- Specifically soft tissue damage such as:
Take Home
- Accelerated functional rehabilitation programs with nonoperative treatments are effective in avoiding re-ruptures and further complications in patients suffering from acute Achilles tendon ruptures
EPCAT II
“Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban To Aspirin Following Total Hip And Knee Arthroplasty (EPCAT II)”
N Engl J Med. 2018 Feb 22;378(8):699-707
Results
- In TKA/THA, conversion to ASA 81mg daily after a short, 5-day course of rivaroxaban 10mg daily demonstrated noninferior efficacy in thromboprophylaxis compared to extended use of rivaroxaban 10mg daily
Take home
- Switching to ASA following a short course of rivaroxaban following TKA/THA provides efficacy similar to extended use of rivaroxaban
- Given the cost differences between the two drugs, cost savings may be available by extended use of ASA following a short course of rivaroxban after surgery
TRUST trial
“Re-evaluation of low intensity pulsed ultrasound in treatment of tibial fractures (TRUST): randomized clinical trial”
BMJ. 2016 Oct 25;355
Results
- Following IM fixation of a tibial shaft fracture, the use of low-intensity pulsed ultrasound (LIPUS) had no significant effect on functional recovery or the time to radiographic union when compared to sham LIPUS
Take home
- Low-intensity pulsed ultrasound does not demonstrate efficacy in improving the time to fracture union or function following fixation of a tibial shaft fracture
- The use of low-intensity pulsed ultrasound appears to be a costly postoperative intervention without any significant benefit to patients recovering from a tibial shaft fracture
PRAISE trial
“Prevalence of abuse and intimate partner violence surgical evaluation (PRAISE) in orthopaedic fracture clinics: a multinational prevalence study”
Lancet. 2013 Sep 7;382(9895):866-76
Results
- Approximately 1 in 6 (16%) women presenting to orthopaedic clinics have experienced intimate partner violence (IPV) in the past year
- 1 in 50 (2%) women were visiting the clinic as a direct result of IPV
- Over a life time, IPV appears to affect close to 1 in every 3 (34.6%) women with MSK injuries
- Prevalence of IPV by region differed significantly, with North America having a higher prevalence
- Orthopaedic surgeons are in a good position to identify and support women who have experienced IPV
Take home
- Based on the relatively high prevalence of women who have suffered from IPV in orthopaedic clinic settings, establishing an identification and support program for these patients is necessary
- With the top cause of death following domestic violence being trauma (42%), surgeon awareness, as well as support programs, at the orthopaedic injury clinic level are crucial
COTS Tightrope
“Improved Reduction of the Tibiofibular Syndesmosis with Tightrope Compared to Screw Fixation: Results of a Randomized Controlled Study”
J Orthop Trauma. 2019 Nov;33(11):531-537
Method
- 103 patients with an unstable syndesmotic injury associated with a malleolar fracture were randomized to syndesmotic stabilization with either a Tightrope device or two cancellous screws
- Malreduction was assessed on CT at 3 months
- Functional outcome and reoperation rate were followed-up for 12 months postoperatively
Results
- The incidence of malreduction at 3 months was significantly lower in the Tightrope group (15%) compared to the screw group (39%) (p=0.028)
- No significant difference between groups was observed in functional outcome measures
- Rate of reoperation was significantly lower in the Tightrope group (2%) compared to the screw group (19%) (p=0.009)
Take home
- The incidence of malreduction and reoperation were both significantly lower in the Tightrope group compared to the screw group
- Functional outcomes did not significantly differ between groups
COTS Ulnar Nerve Transposition
“Simple decompression vs. anterior transposition of the ulnar nerve for distal humerus fractures treated with plate fixation - a multicentre randomized controlled trial”
JSES 2017. 26(10), e335
Method
- 58 patients scheduled for dual plate fixation of a displaced distal humerus fracture were randomized to ulnar nerve management with either simple decompression or anterior transposition
- Primary outcome - ulnar nerve symptoms on the Ulnar Nerve Entrapment Score
- Secondary outcomes:
- PROMs
- Two-point discrimination test
- Nerve conduction studies
- Follow-up was performed over 1 year postop
Take home
- No significant differences between groups for any outcome measure.
COTS AC Joint
“Operative Versus Nonoperative Treatment of Acute Dislocations of the Acromioclavicular Joint: Results of a Multicenter Randomized, Prospective Clinical Trial”
J Orthop Trauma. 2015 Nov;29(11):479-87
Method
- 83 patients with acute, complete acromioclavicular joint dislocation (grade III, IV, and V) treated with hook plate vs. nonop
Results
- DASH scores:
- Significantly better in the non-op group at 6 weeks (p=0.007), and 3 months (p=0.01)
- No difference at 6 months (0.422), 1 year (0.997), and 2 years (p=0.422) post-treatment
- Constant scores:
- Significantly better in the non-op group at 6 weeks (p<0.0001), 3 months (p=0.001), and 6 months (p=0.001)
- No difference at 1 year (p=0.830), and 2 years (p=0.352)
- Radiographic outcomes and joint reduction were significantly better in the operative group
- Operative group experienced acromial erosion in 2 plates and also experienced 2 plate failures
Take home
- Although the operative treatment group achieved significantly better joint reduction, the non-op group achieved better early DASH and Constant scores
- Up to 6 months
- However there were no differences between the groups at the final 2 year follow-up
COTS IM nail vs SHS
“Intramedullary Versus Extramedullary Fixation for Unstable Intertrochanteric Fractures”
J Bone Joint Surg Am. 2015 Dec 2;97(23):1905-12
Methods
- 204 patients with an unstable intertrochanteric hip fracture (AO/OTA 31-A2 = IT with LT fracture) were randomized to undergo fixation using either an IM implant or extramedullary implant (SHS)
Take home
- In patients with an unstable intertrochanteric fracture, IM devices demonstrated significantly reduced femoral neck shortening compared to SHS
- No significant difference in clinical outcome measures between groups after 12 months
- Compared to preop, functional scores were decreased in both groups
McKee TEA
“A multicenter, prospective, randomized, controlled trial of open reduction–internal fixation versus total elbow arthroplasty for displaced intra-articular distal humeral fractures in elderly patients”
J Shoulder Elbow Surg. 2009 Jan-Feb;18(1):3-12
Method
- 42 elderly patients with displaced intra-articular, distal humeral fractures were managed using ORIF or TEA
Take home
- Assessment 2 years post-op supported the use of TEA in this elderly population
- MEPS scores were significantly better in the TEA group, while DASH sores were superior during early follow-ups
- MEPS better with TEA to 2 years
- DASH better with TEA to 6 months
- These findings were accompanied by a trend towards a reduction in complications in the TEA group
COTS Clavicle Fracture
“Nonoperative Treatment Compared
with Plate Fixation of
Displaced Midshaft Clavicular Fractures”
[J Bone Joint Surg Am. 2007 Jan;89(1):1-10]
Methods
- 132 patients with a displaced midshaft clavicle fracture were randomized to either ORIF (plate) or nonop treatment
- 1 year F/U with DASH and Constant scores
Results
- Constant/DASH scores significantly improved in ORIF group at all time-points
- Mean time to radiographic union was 28.4 weeks in the nonop group compared with 16.4 weeks in ORIF group
- 2 nonunions in the ORIF group compared with 7 in the nonop group
- Symptomatic malunion in 9 patients in the nonop group and in none in the ORIF group
- Most complications in the ORIF group were hardware-related
- 1y postop ORIF group more satisfied with the appearance of the shoulder and with the shoulder in general than the nonop group
Take home
- At 1y ORIF of a displaced clavicle shaft fracture results in:
- Improved functional outcome
- Lower rate of malunion and nonunion
- Hardware removal is the most common reason for repeat intervention in the ORIF group
