Postoperative Outcome of Patients Who Underwent Total Joint Replacement During the Tanezumab Phase 3 Osteoarthritis Development Program: A 24-Week Observational Study

Author(s):  
Michael Mont ◽  
John Carrino ◽  
Mary Nemeth ◽  
Aimee Burr ◽  
Takaharu Yamabe ◽  
...  

Introduction: This prospective cohort study (ClinicalTrials.gov identifier: NCT02674386) evaluated the postoperative outcomes of patients who had undergone total joint replacement (TJR) while participating in one of three tanezumab (a nerve growth factor inhibitor) randomized phase 3 osteoarthritis (OA) studies. Materials and Methods: Eligible patients were those who underwent TJR (knee, hip, or shoulder) at any time during any of three tanezumab randomized phase 3 OA studies. Consenting patients were followed for 24 weeks post-surgery. Patients undergoing sub-total arthroplasty procedures were not eligible; there were no further protocol-defined exclusion criteria. Outcomes assessed in relation to joint adjudication outcome and prior tanezumab treatment included: 1) surgeon’s assessment of procedural difficulty (uneventful, minor complications, major complications) at the time of the TJR; 2) postsurgical complications (clinically significant events attributable to the TJR, derived from adverse events) up to week 24; and 3) additional/corrective procedures (procedures or investigations related to the TJR) up to week 24. Results: The 150 patients had received placebo (n=20), tanezumab 2.5mg (n=52), tanezumab 2.5mg titrated to 5mg (tanezumab 2.5/5mg, n=8), tanezumab 5mg (n=53), or a nonsteroidal anti-inflammatory drug (n=17) in the parent studies. The 150 patients were adjudicated to have primary osteonecrosis (n=1), rapidly progressive OA (RPOA) type 2 (n=8), RPOA type 1 (n=3), other joint outcome (n=6), normal progression of OA (NPOA) (n=130), or insufficient information to determine RPOA versus NPOA (n=2). Surgeon’s assessment of procedural difficulty was uneventful for 95.1% (116/122) of patients. Through the 24-week study, there were no postsurgical complications for 96.0% (144/150) of patients; the 6 patients who had complications were all adjudicated as NPOA (tanezumab 2.5mg, n=2; tanezumab 5mg, n=4). There were no additional/corrective procedures for 93.3% (140/150) of patients. Conclusion: Procedural difficulty of minor complications during surgery, postsurgical complications, and additional/corrective procedures were infrequent, although more common with tanezumab 5mg, typically occurring in patients adjudicated as NPOA. Adjudication outcome (RPOA/primary osteonecrosis vs. NPOA) was not associated with postoperative outcome.

2021 ◽  
Author(s):  
◽  
Lynda Sheree Gare

<p>Purpose: To explore patients’ educational experiences and the usefulness and benefits of this health education in the rehabilitation period, when undertaking a total joint replacement. Design & Method: An exploratory, qualitative descriptive study, describing patients’ experiences of health education. Five participants, convenience sampled, were interviewed eight to twelve weeks post surgery following unilateral total joint replacement in a tertiary hospital. Findings: Participants valued the education they received pre operatively, which included written material, video and individual interaction with varied health professionals. Although this was provided in a timely manner, evidence showed limited post operative reinforcement and follow up of given education and preparation for discharge. Three ‘partnership’ themes were identified from data, Communicative, Subservient and Knowledge. ‘Communicative Partnership’ conceptualised the participants’ experiences of the nurse-patient relationship, whilst ‘Subservient Partnership’ captured the participants’ experiences of ‘being’ patients. ‘Knowledge Partnership’ combined the participants’ ideas about knowledge and their retention of this knowledge to assist with their rehabilitation post surgery. Conclusion: The needs and experiences of patients after total joint replacement reflect on transitional change – changes in roles, behaviour, abilities and relationships. Educational contents need to reflect a realistic recovery process to assist with this transitional period, delivered by health care professionals in a manner best suited for patients. This study provides a descriptive study of patients’ perspectives of their journey undergoing a total joint replacement, making the process and their experiences more visible for health professionals. Careful pre and post operative education and planning can facilitate patients' optimism and motivation in their rehabilitation.</p>


2021 ◽  
Author(s):  
◽  
Lynda Sheree Gare

<p>Purpose: To explore patients’ educational experiences and the usefulness and benefits of this health education in the rehabilitation period, when undertaking a total joint replacement. Design & Method: An exploratory, qualitative descriptive study, describing patients’ experiences of health education. Five participants, convenience sampled, were interviewed eight to twelve weeks post surgery following unilateral total joint replacement in a tertiary hospital. Findings: Participants valued the education they received pre operatively, which included written material, video and individual interaction with varied health professionals. Although this was provided in a timely manner, evidence showed limited post operative reinforcement and follow up of given education and preparation for discharge. Three ‘partnership’ themes were identified from data, Communicative, Subservient and Knowledge. ‘Communicative Partnership’ conceptualised the participants’ experiences of the nurse-patient relationship, whilst ‘Subservient Partnership’ captured the participants’ experiences of ‘being’ patients. ‘Knowledge Partnership’ combined the participants’ ideas about knowledge and their retention of this knowledge to assist with their rehabilitation post surgery. Conclusion: The needs and experiences of patients after total joint replacement reflect on transitional change – changes in roles, behaviour, abilities and relationships. Educational contents need to reflect a realistic recovery process to assist with this transitional period, delivered by health care professionals in a manner best suited for patients. This study provides a descriptive study of patients’ perspectives of their journey undergoing a total joint replacement, making the process and their experiences more visible for health professionals. Careful pre and post operative education and planning can facilitate patients' optimism and motivation in their rehabilitation.</p>


2015 ◽  
Author(s):  
Lothar Seefried ◽  
Nicole Luksche ◽  
Michael Schneider ◽  
Franca Genest

Over the last two decades the number of total joint replacement surgeries increased consistently. With the patient population growing older and therefore suffering from more comorbidities and total joint replacement being progressively indicated even in patients with compromised medical status, the need for preoperative optimization of medical conditions appears a promising approach to reduce perioperative risk for complication, and readmission rates, avoid prolonged functional deficiency and improve functional, objective as well as patient reported, subjective outcome following surgery. Literature addressing the question of preoperative status afflicting postoperative outcome after total joint replacement is still imprecise and inconsistent. There seems to be some data, that a worse preoperative functional status predicts worse outcome in terms of both function and pain after total joint replacement. It is still not clear, what preoperatively evaluable parameters can be modified by which kind of intervention and which measures are suitable to monitor improvement of the outcome following such interventions. Based on the hypothesis that patient reported outcome, the frequency of untoward events and functional outcome following total joint replacement can be improved by establishing an individualized concept aiming at improving medical conditions and physical performance preoperatively, the EndoPRIME Trial (ENDOprosthetic joint replacement – improving treatment by integrating Prehabilitation, Rehabilitation, Individualized Management and Education) was initiated. The trial was approved by the competent ethics committee at Wuerzburg University. The project aims at expanding current knowledge about the feasibility and potential of preoperative improvement and quantivfy respective effects on postoperative outcome after total joint replacement, The proposed study is an interventional, prospective, single-center pilot study with exploratory data analysis to evaluate the feasibility and potential of improving peri- and postoperative outcome in total joint replacement of the hip, knee and shoulder by a standardized, individually optimized treatment pathway including pre- and postoperative exercising, risk management and patient education based on a comprehensive preoperative functional assessment and expanded clinical evaluation. Study duration for each individual patient comprises 12 weeks prior to surgery and one year after surgery, i.e. individual participation will last weeks. The primary endpoint of the trial is intraindividual development of osteoarthritis-associated health-limitations as measured by the WOMAC-Score. Further objectives include Patient Reported Outcome measures, type and frequency of perioperative untoward events, and a wide range of clinical and technical assessments of physical performance. Results can be expected by the third quarter 2017.


2015 ◽  
Author(s):  
Lothar Seefried ◽  
Nicole Luksche ◽  
Michael Schneider ◽  
Franca Genest

Over the last two decades the number of total joint replacement surgeries increased consistently. With the patient population growing older and therefore suffering from more comorbidities and total joint replacement being progressively indicated even in patients with compromised medical status, the need for preoperative optimization of medical conditions appears a promising approach to reduce perioperative risk for complication, and readmission rates, avoid prolonged functional deficiency and improve functional, objective as well as patient reported, subjective outcome following surgery. Literature addressing the question of preoperative status afflicting postoperative outcome after total joint replacement is still imprecise and inconsistent. There seems to be some data, that a worse preoperative functional status predicts worse outcome in terms of both function and pain after total joint replacement. It is still not clear, what preoperatively evaluable parameters can be modified by which kind of intervention and which measures are suitable to monitor improvement of the outcome following such interventions. Based on the hypothesis that patient reported outcome, the frequency of untoward events and functional outcome following total joint replacement can be improved by establishing an individualized concept aiming at improving medical conditions and physical performance preoperatively, the EndoPRIME Trial (ENDOprosthetic joint replacement – improving treatment by integrating Prehabilitation, Rehabilitation, Individualized Management and Education) was initiated. The trial was approved by the competent ethics committee at Wuerzburg University. The project aims at expanding current knowledge about the feasibility and potential of preoperative improvement and quantivfy respective effects on postoperative outcome after total joint replacement, The proposed study is an interventional, prospective, single-center pilot study with exploratory data analysis to evaluate the feasibility and potential of improving peri- and postoperative outcome in total joint replacement of the hip, knee and shoulder by a standardized, individually optimized treatment pathway including pre- and postoperative exercising, risk management and patient education based on a comprehensive preoperative functional assessment and expanded clinical evaluation. Study duration for each individual patient comprises 12 weeks prior to surgery and one year after surgery, i.e. individual participation will last weeks. The primary endpoint of the trial is intraindividual development of osteoarthritis-associated health-limitations as measured by the WOMAC-Score. Further objectives include Patient Reported Outcome measures, type and frequency of perioperative untoward events, and a wide range of clinical and technical assessments of physical performance. Results can be expected by the third quarter 2017.


2015 ◽  
Vol 137 (4) ◽  
Author(s):  
David C. Ackland ◽  
Adrian Moskaljuk ◽  
Chris Hart ◽  
Peter Vee Sin Lee ◽  
George Dimitroulis

One of the most widely reported complications associated with temporomandibular joint (TMJ) prosthetic total joint replacement (TJR) surgery is condylar component screw loosening and instability. The objective of this study was to develop a musculoskeletal model of the human jaw to assess the influence of prosthetic condylar component orientation and screw placement on condylar component loading during mastication. A three-dimensional model of the jaw comprising the maxilla, mandible, masticatory muscles, articular cartilage, and articular disks was developed. Simulations of mastication and a maximum force bite were performed for the natural TMJ and the TMJ after prosthetic TJR surgery, including cases for mastication where the condylar component was rotated anteriorly by 0 deg, 5 deg, 10 deg, and 15 deg. Three clinically significant screw configurations were investigated: a complete, posterior, and minimal-posterior screw (MPS) configuration. Increases in condylar anterior rotation led to an increase in prosthetic condylar component contact stresses and substantial increases in condylar component screw stresses. The use of more screws in condylar fixation reduced screw stress magnitudes and maximum condylar component stresses. Screws placed superiorly experienced higher stresses than those of all other condylar fixation screws. The results of the present study have important implication for the way in which prosthetic components are placed during TMJ prosthetic TJR surgery.


Author(s):  
Ali Kiapour ◽  
Vijay K. Goel ◽  
Manoj Krishna ◽  
Sarath Koruprolu

Total lumbar disc replacements (TDRs) are designed to restore kinematics of a degenerated segment [1]. Compared to the fusion of the segment, disc replacements may prevent adjacent segment degeneration. Various designs have been proposed for lumbar TDR; however most of these require an anterior surgical intervention for placement. Post-surgery facet pain and degeneration are shown to occur. Complicated surgical procedure and difficulty in revision are other deficiencies of anterior discs concept. Posterior disc designs are novel alternatives for restoring kinematics across the implanted spine and posses the ability to overcome the limitations of anterior lumbar arthroplasty.


2019 ◽  
Author(s):  
Joana Barroso ◽  
Kenta Wakaizumi ◽  
Diane Reckziegel ◽  
João Pinto-Ramos ◽  
Thomas Schnitzer ◽  
...  

AbstractA significant proportion of osteoarthritis (OA) patients continues to experience moderate to severe pain after total joint replacement (TJR). So far, preoperative factors related to pain persistence have been mainly studied using individual predictor variables and distinct pain outcomes, thus leading to lack of consensus in the field. In this prospective observational study, we evaluated knee and hip OA patients before, 3 and 6 months post-TJR searching for clinical predictors of pain persistence. We assessed multiple measures of quality, mood, affect, health and quality of life, together with radiographic evaluation and performance-based tasks, modeling four distinct pain outcomes. Multivariate regression models were built, and a network analysis was applied to pain related biopsychosocial measures and their change with surgery. A total of 106 patients completed the study. Pre-surgical pain levels were not related to post-surgical residual pain. Distinct pain scales were associated with different aspects of the pain experience. Multi-factorial models did not reliably predict post-surgical pain in knee OA across four distinct pain scales and did not generalize to hip OA; however, network analysis of pain related biopsychosocial measures showed significant changes post-surgery in both groups. Our results show that although tested clinical and biopsychosocial variables are reorganizing after TJR in OA, they do not present as a robust markers for post-surgery pain outcomes. A better understanding of mechanisms underlying pain persistence after TJR is necessary to derive clinical prognostic factors.


2015 ◽  
Author(s):  
Lothar Seefried ◽  
Nicole Luksche ◽  
Michael Schneider ◽  
Franca Genest

Over the last two decades the number of total joint replacement surgeries increased consistently. With the patient population growing older and therefore suffering from more comorbidities and total joint replacement being progressively indicated even in patients with compromised medical status, the need for preoperative optimization of medical conditions appears a promising approach to reduce perioperative risk for complication, and readmission rates, avoid prolonged functional deficiency and improve functional, objective as well as patient reported, subjective outcome following surgery. Literature addressing the question of preoperative status afflicting postoperative outcome after total joint replacement is still imprecise and inconsistent. There seems to be some data, that a worse preoperative functional status predicts worse outcome in terms of both function and pain after total joint replacement. It is still not clear, what preoperatively evaluable parameters can be modified by which kind of intervention and which measures are suitable to monitor improvement of the outcome following such interventions. Based on the hypothesis that patient reported outcome, the frequency of untoward events and functional outcome following total joint replacement can be improved by establishing an individualized concept aiming at improving medical conditions and physical performance preoperatively, the EndoPRIME Trial (ENDOprosthetic joint replacement – improving treatment by integrating Prehabilitation, Rehabilitation, Individualized Management and Education) was initiated. The trial was approved by the competent ethics committee at Wuerzburg University. The project aims at expanding current knowledge about the feasibility and potential of preoperative improvement and quantivfy respective effects on postoperative outcome after total joint replacement, The proposed study is an interventional, prospective, single-center pilot study with exploratory data analysis to evaluate the feasibility and potential of improving peri- and postoperative outcome in total joint replacement of the hip, knee and shoulder by a standardized, individually optimized treatment pathway including pre- and postoperative exercising, risk management and patient education based on a comprehensive preoperative functional assessment and expanded clinical evaluation. Study duration for each individual patient comprises 12 weeks prior to surgery and one year after surgery, i.e. individual participation will last weeks. The primary endpoint of the trial is intraindividual development of osteoarthritis-associated health-limitations as measured by the WOMAC-Score. Further objectives include Patient Reported Outcome measures, type and frequency of perioperative untoward events, and a wide range of clinical and technical assessments of physical performance. Results can be expected by the third quarter 2017.


1992 ◽  
Vol 63 (6) ◽  
pp. 658-660
Author(s):  
Michel Boeckstyns ◽  
Marianne Backer ◽  
Else Petersen ◽  
Iben Høj ◽  
Henrik Albrechtsen ◽  
...  

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