scholarly journals Flexible versus standard intramedullary rod in posterior stabilized primary total knee arthroplasty: protocol for a randomized controlled trial

2020 ◽  
Vol 15 (1) ◽  
Author(s):  
M. R. Bénard ◽  
R. F. M. van Doremalen ◽  
A. B. Wymenga ◽  
P. J. C. Heesterbeek
Keyword(s):  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Functional Outcome ◽  
Distal Femur ◽  
Controlled Trial ◽  
Sagittal Profile ◽  
Randomized Controlled ◽  
Total Knee ◽  
Intramedullary Rod ◽  
Group Allocation

Abstract Background In total knee arthroplasty (TKA) a flexible intramedullary rod can be used to account for sagittal bowing of the distal femur. Although patients report better post-operative functional outcome when the flexible rod was used, it is unknown how the use of the flexible rod affects the placement of the femoral TKA component, and how this relates to activities of daily living. It is expected that the use of the flexible rod will result in a more flexed femoral component, a larger patellar tendon moment arm, and consequently in better functional outcome. The goal of this study is to compare the flexible rod to the standard intramedullary rod in primary TKA in terms of fit of the TKA, functional outcome, and sizing of the femoral component. Methods A single-blind randomized controlled trial with two groups (flexible vs standard rod), with patients blinded for group allocation, and 2 years post-operative follow-up. The fit of the TKA is quantified by two parameters: (1) the flexion angle of the TKA in the sagittal plane and (2) the sagittal profile of the distal femur compared between the pre-operative bone and the TKA. Both parameters are calculated in 3D volume images obtained using fluoroscopy. Functional outcome will be measured using (1) the timed Get-up and Go test (2), the stair climbing test (3), knee power output, and (4) patient and clinician reported outcomes. Different parameters will be measured during the TKA procedure to account for the invisibility of cartilage in the 3D volumes and to study if the amount of bone removed during the procedure is affected by group allocation. Discussion The sagittal fit of TKA is not a standardized outcome measure. We discuss our choice of parameters to define the sagittal fit (i.e., flexion angle and sagittal profile), our choice for the parameters we measure during the TKA procedure to account for the lack of cartilage thickness in fluoroscopy, and our choice for the parameters to study if the amount of bone removed during the procedure is affected by group allocation. Lastly, we discuss the merits of this planned trial. Trial registration Netherlands Trial Register, 4888, registered 30 March 2015. https://www.trialregister.nl/trial/4888

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

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