scholarly journals Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

2021 ◽  
Vol 10 (7) ◽  
pp. 1527
Author(s):  
Jamie Duckers ◽  
Beth Lesher ◽  
Teja Thorat ◽  
Eleanor Lucas ◽  
Lisa J. McGarry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Real World ◽  
Safety Profile ◽  
Clinical Trial Data ◽  
Patient Characteristics ◽  
Healthcare Resource Utilization ◽  
Patient Reported ◽  
Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

scholarly journals Real-World Safety of CFTR Modulators in the Treatment of Cystic Fibrosis: A Systematic Review

2020 ◽  
Vol 10 (1) ◽  
pp. 23
Author(s):  
Renée V. E. Dagenais ◽  
Victoria C. Su ◽  
Bradley S. Quon
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Clinical Trials ◽  
Real World ◽  
Observational Studies ◽  
Case Reports ◽  
Case Series ◽  
Patient Characteristics ◽  
Online Databases ◽  
Cftr Modulators

Cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapies target the underlying cause of cystic fibrosis (CF), and are generally well-tolerated; however, real-world studies indicate the frequency of discontinuation and adverse events (AEs) may be higher than what was observed in clinical trials. The objectives of this systematic review were to summarize real-world AEs reported for market-available CFTR modulators (i.e., ivacaftor (IVA), lumacaftor/ivacaftor (LUM/IVA), tezacaftor/ivacaftor (TEZ/IVA), and elexacaftor/tezacaftor/ivacaftor (ELX/TEZ/IVA)), and to identify ways in which the pharmacist on CF healthcare teams may contribute to mitigating and managing these AEs. The MEDLINE, EMBASE, CINAHL, and Web of Science Core Collection online databases were searched from 2012 to 1 Aug 2020. Full manuscripts or conference abstracts of observational studies, case series, and case reports were eligible for inclusion. The included full manuscripts and conference abstracts comprised of 54 observational studies, 5 case series, and 9 case reports. The types of AEs reported generally aligned with what have been observed in clinical trials. LUM/IVA was associated with a higher frequency of respiratory-related AE and discontinuation in real-world studies. A signal for mental health and neurocognitive AEs was identified with all 4 CFTR modulators. A systematic approach to monitoring for AEs in people with CF on CFTR modulators in the real-world setting is necessary to help better understand potential AEs, as well as patient characteristics that may be associated with higher risk of certain AEs. Pharmacists play a key role in the safe initiation and monitoring of people with CF on CFTR modulator therapies.

349 Cognitive Behavioral Therapy for Insomnia in Patients with Chronic Pain - A Systematic Review and Meta-Analysis

SLEEP ◽  
2021 ◽  
Vol 44 (Supplement_2) ◽  
pp. A139-A140
Author(s):  
Janannii Selvanathan ◽  
Chi Pham ◽  
Mahesh Nagappa ◽  
Philip Peng ◽  
Marina Englesakis ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cognitive Behavioral Therapy ◽  
Cancer Pain ◽  
Behavioral Therapy ◽  
Meta Analysis ◽  
Post Treatment ◽  
Cognitive Behavioral ◽  
Comorbid Insomnia ◽  
Patient Reported

Abstract Introduction Patients with chronic non-cancer pain often report insomnia as a significant comorbidity. Cognitive behavioral therapy for insomnia (CBT-I) is recommended as the first line of treatment for insomnia, and several randomized controlled trials (RCTs) have examined the efficacy of CBT-I on various health outcomes in patients with comorbid insomnia and chronic non-cancer pain. We conducted a systematic review and meta-analysis on the effectiveness of CBT-I on sleep, pain, depression, anxiety and fatigue in adults with comorbid insomnia and chronic non-cancer pain. Methods A systematic search was conducted using ten electronic databases. The duration of the search was set between database inception to April 2020. Included studies must be RCTs assessing the effects of CBT-I on at least patient-reported sleep outcomes in adults with chronic non-cancer pain. Quality of the studies was assessed using the Cochrane risk of bias assessment and Yates quality rating scale. Continuous data were extracted and summarized using standard mean difference (SMD) with 95% confidence intervals (CIs). Results The literature search resulted in 7,772 articles, of which 14 RCTs met the inclusion criteria. Twelve of these articles were included in the meta-analysis. The meta-analysis comprised 762 participants. CBT-I demonstrated a large significant effect on patient-reported sleep (SMD = 0.87, 95% CI [0.55–1.20], p < 0.00001) at post-treatment and final follow-up (up to 9 months) (0.59 [0.31–0.86], p < 0.0001); and moderate effects on pain (SMD = 0.20 [0.06, 0.34], p = 0.006) and depression (0.44 [0.09–0.79], p= 0.01) at post-treatment. The probability of improving sleep and pain following CBT-I at post-treatment was 81% and 58%, respectively. The probability of improving sleep and pain at final follow-up was 73% and 57%, respectively. There were no statistically significant effects on anxiety and fatigue. Conclusion This systematic review and meta-analysis showed that CBT-I is effective for improving sleep in adults with comorbid insomnia and chronic non-cancer pain. Further, CBT-I may lead to short-term moderate improvements in pain and depression. However, there is a need for further RCTs with adequate power, longer follow-up periods, CBT for both insomnia and pain, and consistent scoring systems for assessing patient outcomes. Support (if any):

scholarly journals Outcomes of Arthroscopic Capsular Release in the Beach-Chair Versus Lateral Decubitus Position: A Systematic Review

2019 ◽  
Vol 7 (12) ◽  
pp. 232596711988817 ◽  
Author(s):  
Darby A. Houck ◽  
John W. Belk ◽  
Armando F. Vidal ◽  
Eric C. McCarty ◽  
Jonathan T. Bravman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
Cochrane Library ◽  
Recurrence Rates ◽  
Capsular Release ◽  
Arthroscopic Capsular Release ◽  
Patient Reported ◽  
Lateral Decubitus ◽  
Beach Chair

Background: Arthroscopic capsular release (ACR) for the treatment of adhesive capsulitis of the shoulder can be performed in either the beach-chair (BC) or lateral decubitus (LD) position. Purpose: To determine the clinical outcomes and recurrence rates after ACR in the BC versus LD position. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines was performed by searching PubMed, Embase, and the Cochrane Library databases for studies reporting clinical outcomes of patients undergoing ACR in either the BC or LD position. All English-language literature from 1990 through 2017 reporting on clinical outcomes after ACR with a minimum 3-month follow-up were reviewed by 2 independent reviewers. Recurrence rates, range of motion (ROM) results, and patient-reported outcome (PRO) scores were collected. Study methodological quality was evaluated using the modified Coleman Methodology Score (MCMS). Results: A total of 30 studies (3 level 1 evidence, 2 level 2 evidence, 4 level 3 evidence, 21 level 4 evidence) including 665 shoulders undergoing ACR in the BC position (38.1% male; mean age, 52.0 ± 3.9 years; mean follow-up, 35.4 ± 18.4 months) and 603 shoulders in the LD position (41.8% male; mean age, 53.0 ± 2.3 years; mean follow-up, 37.2 ± 16.8 months) were included. There were no significant differences in overall mean recurrence rates between groups (BC, 2.5%; LD, 2.4%; P = .81) or in any PRO scores between groups ( P > .05). There were no significant differences in improvement in ROM between groups, including external rotation at the side (BC, 36.4°; LD, 42.8°; P = .91), forward flexion (BC, 64.4°; LD, 79.3°; P = .73), abduction (BC, 77.8°; LD, 81.5°; P = .82), or internal rotation in 90° of abduction (BC, 40.8°; LD, 45.5°; P = .70). Significantly more patients in the BC group (91.6%) underwent concomitant manipulation than in the LD group (63%) ( P < .0001). There were significantly more patients with diabetes in the LD group (22.4%) versus the BC group (9.6%) ( P < .0001). Conclusion: Low rates of recurrent shoulder stiffness and excellent improvements in ROM can be achieved after ACR in either the LD or BC position. Concomitant manipulation under anesthesia is performed more frequently in the BC position compared with the LD position.

Twenty-Year Outcomes After Anterior Cruciate Ligament Reconstruction: A Systematic Review of Prospectively Collected Data

2021 ◽  
pp. 036354652110273
Author(s):  
Joshua S. Everhart ◽  
Sercan Yalcin ◽  
Kurt P. Spindler
Keyword(s):  
Systematic Review ◽  
Anterior Cruciate Ligament ◽  
Acl Reconstruction ◽  
Cruciate Ligament ◽  
Knee Function ◽  
Increased Risk ◽  
Patient Reported ◽  
The Mean ◽  
Anterior Cruciate

Background: Several long-term (≥20 years) follow-up studies after anterior cruciate ligament (ACL) reconstruction have been published in recent years, allowing for a systematic evaluation of outcomes. Purpose: To summarize outcomes at ≥20 years after ACL reconstruction and identify patient and surgical factors that affect these results. Study Design: Systematic review; Level of evidence, 4. Methods: Prospective studies of primary ACL reconstructions with hamstring or bone–patellar tendon—bone (BTB) autograft via an arthroscopic or a mini-open technique and with a mean follow-up of ≥20 years were identified. When possible, the mean scores for each outcome measure were calculated. Factors identified in individual studies as predictive of outcomes were described. Results: Five studies met the inclusion and exclusion criteria with a total of 2012 patients. The pooled mean follow-up for patient-reported outcome measures was 44.2% (range, 29.6%-92.7%) and in-person evaluation was 33.2% (range, 29.6%-48.9%). Four studies (n = 584) reported graft tears at a mean rate of 11.8% (range, 2%-18.5%) and 4 studies (n = 773) reported a contralateral ACL injury rate of 12.2% (range, 5.8%-30%). Repeat non-ACL arthroscopic surgery (4 studies; n = 177) to the ipsilateral knee occurred in 10.4% (range, 9.5%-18.3%) and knee arthroplasty (1 study; n = 217) in 5%. The pooled mean of the International Knee Documentation Committee subjective knee function (IKDC) score was 79.1 (SD, 21.8 [3 studies; n = 644]). In 2 studies (n?= 221), 57.5% of patients continued to participate in strenuous activities. The IKDC-objective score was normal or nearly normal in 82.3% (n = 496; 3 studies), with low rates of clinically significant residual laxity. Moderate-severe radiographic osteoarthritis (OA) (IKDC grade C or D) was present in 25.9% of patients (n = 605; 3 studies). Medial meniscectomy is associated with increased risk of radiographic OA. Radiographic OA severity is associated with worse patient-reported knee function, but the association with knee pain is unclear. Conclusion: Currently available prospective evidence for ACL reconstruction with hamstring or BTB autograft provides several insights into outcomes at 20 years. The rates of follow-up at 20 years range from 30% to 93%. IKDC-objective scores were normal or nearly normal in 82% and the mean IKDC-subjective score was 79 points.

Real-world evidence of cancer immunotherapy (CIT) combination treatment in first-line (1L) extensive-stage small cell lung cancer (ES-SCLC).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  
Keyword(s):  
Brain Metastases ◽  
Real World ◽  
Performance Status ◽  
Descriptive Analysis ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Combination Regimen ◽  
Duration Of Treatment ◽  
The Real

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]

Outcomes of Hip Arthroscopic Surgery in Adolescents With a Subanalysis on Return to Sport: A Systematic Review

2019 ◽  
Vol 48 (6) ◽  
pp. 1526-1534
Author(s):  
Sarah L. Chen ◽  
David R. Maldonado ◽  
Cammille C. Go ◽  
Cynthia Kyin ◽  
Ajay C. Lall ◽  
...  
Keyword(s):  
Systematic Review ◽  
Short Form ◽  
Adult Population ◽  
Arthroscopic Surgery ◽  
Return To Sport ◽  
Functional Improvement ◽  
Harris Hip Score ◽  
Patient Reported ◽  
The Mean

Background: There is a plethora of literature on outcomes after hip arthroscopic surgery in the adult population; however, outcomes in the adolescent population have not been as widely reported. Additionally, as adolescents represent a very active population, it is imperative to understand their athletic activity and return to sport after hip arthroscopic surgery. Purpose: To analyze patient-reported outcomes (PROs) after hip arthroscopic surgery in adolescents (aged 10-19 years) and present a return-to-sport analysis in the athletic adolescent subgroup. Study Design: Systematic review; Level of evidence, 4. Methods: The PubMed, Embase, and Cochrane databases were searched according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to identify articles that reported PROs after hip arthroscopic surgery in adolescents. The standardized mean difference was calculated to compare the effect size of hip arthroscopic surgery on various PROs. For the athletic subgroup, a return-to-sport summary was also provided. Results: Ten studies, with 618 adolescent hips and a collective study period of December 2004 to February 2015, were included in this systematic review. Across all studies, the mean age was 15.8 years (range, 11.0-19.9 years), and female patients composed approximately 56.7% of the entire cohort. The mean follow-up was 34.5 months (range, 12-120 months). The modified Harris Hip Score (mHHS) was reported in 9 studies, and at latest follow-up, scores were excellent in 4 studies (range, 90-95) and good in the remaining 5 studies (range, 82.1-89.6). All adolescents also showed significant improvement on the Non-Arthritic Hip Score (NAHS), the Hip Outcome Score–Activities of Daily Living (HOS-ADL), the HOS–Sport-Specific Subscale (HOS-SSS), the physical component of the 12-Item Short Form Health Survey (SF-12P), a visual analog scale for pain (VAS), and both versions of the International Hip Outcome Tool (iHOT-12 and iHOT-33) at latest follow-up ( P < .05). Further, mean improvements reported in all studies surpassed reported values of the minimal clinically important difference and patient acceptable symptomatic state for the mHHS, HOS-ADL, HOS-SSS, and iHOT-33. Finally, the collective return-to-sport rate among athletic adolescents was 84.9%. Conclusion: In the setting of labral tears and femoroacetabular impingement, hip arthroscopic surgery can safely be performed in adolescents and leads to significant functional improvement. Furthermore, athletic adolescents return to sport at high levels after hip arthroscopic surgery.

scholarly journals Thumb CMCJ prosthetic total joint replacement: a systematic review

2021 ◽  
Vol 6 (5) ◽  
pp. 316-330
Author(s):  
Thomas J. Holme ◽  
Marta Karbowiak ◽  
Jennifer Clements ◽  
Ritesh Sharma ◽  
Johnathan Craik ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cohort Studies ◽  
Joint Replacement ◽  
Total Joint Replacement ◽  
Resection Arthroplasty ◽  
High Quality ◽  
Painful Condition ◽  
Pain Scores ◽  
Patient Reported

Thumb carpometacarpal joint (CMCJ) arthritis is a common and painful condition. Thumb CMCJ prosthetic replacement aims to restore thumb biomechanics and improve pain and function. Early reviews demonstrated a lack of high-quality studies, but more recently a significant number of higher-quality studies have been published. This review provides a concise and systematic overview of the evidence to date. A systematic review of several databases was conducted according to PRISMA guidelines. Studies evaluating the outcomes of thumb CMCJ prosthetic total joint replacement were included. Data extracted included patient-reported outcome measures (PROMs), pain scores, range of motion, strength, survival rates and complications. A total of 56 studies met all inclusion criteria and were analysed. There was one randomized controlled trial, three prospective comparative cohort studies, five retrospective comparative cohort studies, and 47 descriptive cohort studies. The reported studies included 2731 patients with 3048 thumb total CMCJ prosthetic joint replacements. Follow up ranged from 12 months to 13.1 years. In general, good results were demonstrated, with improvements in PROMs, pain scores and strength. Failure rates ranged from 2.6% to 19.9% depending upon implant studied. Comparative studies demonstrated promising results for replacement when compared to resection arthroplasty, with modest improvements in PROMs but at a cost of increased rates of complications. Studies reporting outcomes in thumb CMCJ prosthetic total joint replacement are increasing in both number and quality. Failure, in terms of loosening and dislocation, remains a concern, although in the medium-term follow up for modern implants this issue appears to be lower when compared to their predecessors. Functional outcomes also look promising compared to resection arthroplasty, but further high-quality studies utilizing a standardized resection arthroplasty technique and modern implants, together with standardized core outcome sets, will be of value. Cite this article: EFORT Open Rev 2021;6:316-330. DOI: 10.1302/2058-5241.6.200152

Are Subchondral Intraosseous Injections Effective and Safe for the Treatment of Knee Osteoarthritis? A Systematic Review

2019 ◽  
Vol 32 (11) ◽  
pp. 1046-1057 ◽  
Author(s):  
Kavin Sundaram ◽  
Juan S. Vargas-Hernández ◽  
Tomas Roca Sanchez ◽  
Nestor Moreno Moreu ◽  
Michael A. Mont ◽  
...  
Keyword(s):  
Systematic Review ◽  
Knee Osteoarthritis ◽  
Knee Arthroplasty ◽  
Bone Substitute ◽  
Knee Oa ◽  
Patient Reported ◽  
Intraosseous Injection ◽  
Bone Substitute Materials ◽  
Substitute Materials

AbstractKnee osteoarthritis (OA) is a highly prevalent disease and treatment options for early stages of OA are needed. Intraosseous injections of bone substitute and biologic materials have been proposed to expand the therapeutic arsenal by potentially halting OA progression and delaying the need for knee arthroplasty in patients with early/moderate-stage disease. Therefore, the goal of this study was assessed the efficacy and safety of subchondral intraosseous injection for the treatment of knee OA. A systematic review was performed on PubMed-Medline, and the Cochrane Database of systematic reviews. English and Spanish retrospective and prospective studies assessing the results of subchondral intraosseous injection of bone substitute materials and/or biologicals in human patients with knee OA, with a minimum of 6 months of follow-up were collected. A total of 1,081 potential articles were identified through our search. Six studies were included with a total of 163 patients. The mean follow-up was 18 months (range: 6–24 months). Patient reported outcomes measures (PROMs), complications, and conversion to total knee arthroplasty (TKA) were collected. All six studies showed PROMs improvement relative to baseline. Overall, the five studies reporting visual-analog scale (VAS) pain outcomes improved from a baseline mean score of 6.68 to 2.74. Also, knee injury and osteoarthritis score (KOOS), Tegner-Lysholm, and/or international knee documentation committee (IKDC) scores rose compared with baseline scores in all studies. Overall, 2.5% (4/163) of patients had a complication attributed to study-related treatment. Most patients (81%, 86/106) remained TKA-free at a 1-year follow-up. Subchondral intraosseous injections of bone substitute materials and platelet-rich plasma (PRP) suggest (1) improved PROMs of pain and functional status, (2) low complication rate, and (3) relatively low rates of conversion to TKA. However, the current studies investigating these treatments exhibited high degree of heterogeneity in both measurement of outcomes and delivery of treatment, with a high risk of bias. This procedure should not be utilized in advanced knee OA. In light of the limitations of the current literature, advising in favor or against this therapy for early to moderate knee OA is challenging.

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