Novel assessment of leukocyte-rich platelet rich plasma on functional and patient reported outcomes in knee osteoarthritis: a pilot study

2021 ◽  
Author(s):  
Prathap Jayaram ◽  
Gu Eon Kang ◽  
Brett L Heldt ◽  
Olumide Sokunbi ◽  
Bo Song ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Platelet Rich Plasma ◽  
Early Time ◽  
Therapeutic Effects ◽  
Timed Up And Go ◽  
End Points ◽  
Time Points ◽  
Gait Parameters ◽  
Patient Reported

Background: Leukocyte-rich platelet-rich plasma (LR-PRP) has demonstrated to be beneficial for patient with knee osteoarthritis (KOA); however, reliable objective end points to accurately assess its therapeutic effects is lacking. Aim: To investigate the efficacy of LR-PRP as assessed by functional and patient-reported outcomes at early time-points (6 weeks). Materials & methods: We conducted a prospective cohort study in 12 patients with diagnosed KOA (Kellgren Lawrence score of II–III), who underwent a single ultrasound-guided LR-PRP injection. Results: There was significant improvement in timed up and go, pain and quality of life scales and balance parameters. There were nonsignificant improvements in range of motion and gait parameters. Conclusion: LR-PRP demonstrates efficacy in meaningful end points for functional and patient reported outcomes at early time points in patients with KOA.

scholarly journals The Treatment of Bone Marrow Lesions Associated with Advanced Knee Osteoarthritis: Comparing Intraosseous and Intraarticular Injections with Bone Marrow Concentrate and Platelet Products

2021 ◽  
pp. E279-E288
Author(s):  
Ehren Dodson
Keyword(s):  
Bone Marrow ◽  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Platelet Rich Plasma ◽  
Intraarticular Injection ◽  
Bone Marrow Concentrate ◽  
Bone Marrow Lesions ◽  
Treatment Groups ◽  
Patient Reported ◽  
Intraosseous Injection

Background: Bone marrow lesions are a radiographic indication of bony pathology closely associated with advanced osteoarthritis of the adjacent joint. Injection of autologous orthobiologic products, including bone marrow concentrate and platelet-rich plasma, have demonstrated safety and efficacy in treating both advanced osteoarthritis (via intraarticular injection) and associated bone marrow lesions (via intraosseous injection). The relative efficacy of intraarticular versus intraosseous injection of orthobiologics has not been evaluated at the present time. Objectives: The objective was to evaluate differences in orthobiologic bone marrow lesions treatment, either as a collateral result of intraarticular injection with bone marrow concentrate and platelet products alone, or intraosseous plus intraarticular injection as measured by patient reported outcomes. Study Design: This study employed a prospective case-matched cohort design. Setting: This study took place at a single outpatient interventional orthopedic pain clinic. Methods: Using data from a prospective orthobiologic treatment registry of knee patients, a population of knee osteoarthritis with bone marrow lesions patients who had undergone only intraarticular knee injections of bone marrow concentrate and platelets (for symptomatic advanced osteoarthritis) were age, gender, and disease severity case-matched to a series of advanced osteoarthritis and bone marrow lesions patients who underwent intraosseous plus intraarticular injections. Self-reported patient outcomes for Numeric Pain Scale, International Knee Documentation Committee, lower extremity functional scale, and a modified single assessment numeric evaluation were compared between the 2 treatment groups. Results: Eighty patients were included, 40 in each group. Although pain and functional outcome scores were significantly improved in both treatment groups, there was no statistically significant differences in patient reported outcomes based on the type of treatment. Limitations: There are several limitations to this study, including multiple providers performing the injections, varying onset of symptoms to treatment, and additional injections after their initial treatment, that were not controlled. In addition, increasing the sample size may be beneficial as well, particularly with the large bone marrow lesions group, which did suggest possible improvement with intraosseous plus intraarticular over the intraarticular, although was not statistically significant in our sample. Limited data availability for this cohort as well as some missing data are other limitations to consider. Conclusion: Treating knee bone marrow lesions with intraosseous bone marrow concentrate and platelet products did not affect patient reported outcomes. Key words: Intraosseous, intraarticular, bone marrow concentrate, bone marrow lesion, bone marrow edema, knee osteoarthritis, platelet-rich plasma, injection

Comparing Patient-Reported Outcomes From Sham and Saline-Based Placebo Injections for Knee Osteoarthritis: Data From a Randomized Clinical Trial of Lorecivivint

2022 ◽  
pp. 036354652110672
Author(s):  
Jeyanesh R.S. Tambiah ◽  
Ismail Simsek ◽  
Christopher J. Swearingen ◽  
Sarah Kennedy ◽  
Brian J. Cole ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Rating Scale ◽  
Numeric Rating Scale ◽  
Womac Pain ◽  
Time Points ◽  
Knee Oa ◽  
Patient Reported ◽  
Mean Differences ◽  
Numeric Rating

Background: Durable, meaningful symptom responses to intra-articular saline placebo injections are observed in knee osteoarthritis (OA) trials, but it is unclear if these are due to physiological effects. Purpose: To perform a prospective comparison of patient-reported outcome responses among participants with knee OA who underwent intra-articular injection of saline-based placebo or sham (dry needle). Study Design: Randomized controlled trial; Level of evidence, 2. Methods: From a 24-week randomized double-blind trial, participants with moderate to severe knee OA received 2-mL intra-articular injections of saline-based placebo (PBO; 99.45% PBS) or sham (dry needle) to the target knee. Least squares mean differences of changes from baseline to week 24 were compared between the PBO and sham groups for the following: pain Numeric Rating Scale; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness, and function; and patient global assessment. Bang Blinding Index was used to evaluate all-group blinding on day 1 and week 24. Results: In total, 116 and 117 participants were randomized to the PBO and sham groups, respectively. Within the full trial population, the mean ± SD age and body mass index were 59.0 ± 8.5 years and 28.97 ± 4.01, respectively. An overall 406 (58.4%) were female, and 394 (57.3%) had Kellgren-Lawrence grade 3 target knee OA. The PBO and sham groups demonstrated clinically meaningful improvements (≥10%) from baseline in all patient-reported outcomes at all time points (ie, weeks 4-24). Mean differences (95% CI) at week 24 between the PBO and sham groups were as follows: pain Numeric Rating Scale, –0.10 (–0.79 to 0.59; P = .78); WOMAC pain, –2.89 (–9.70 to 3.92; P = .40); WOMAC stiffness, –2.37 (–9.37 to 4.63; P = .51); and WOMAC function, –1.39 (–8.06 to 5.29; P = .68). Bang Blinding Index indicated that blinding was maintained. Conclusion: PBO and sham groups demonstrated equivalent patient-reported outcomes at all time points through week 24, suggesting that responses attributed to saline were contextual (ie, to the procedure) and not physiological. Registration: NCT03122860 (ClinicalTrials.gov identifier).

Treating Knee Osteoarthritis With Platelet-Rich Plasma and Hyaluronic Acid Combination Therapy: A Systematic Review

2021 ◽  
pp. 036354652199801
Author(s):  
Michael R. Baria ◽  
W. Kelton Vasileff ◽  
James Borchers ◽  
Alex DiBartola ◽  
David C. Flanigan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Hyaluronic Acid ◽  
Combination Therapy ◽  
Knee Osteoarthritis ◽  
Platelet Rich Plasma ◽  
Case Series ◽  
Final Analysis ◽  
Preparation Technique ◽  
Randomized Studies ◽  
Patient Reported

Background: Platelet-rich plasma (PRP) and hyaluronic acid (HA) are injectable treatments for knee osteoarthritis. The focus of previous studies has compared their efficacy against each other as monotherapy. However, a new trend of combining these 2 injections has emerged in an attempt to have a synergistic effect. Purpose: To systematically review the clinical literature examining the combined use of PRP + HA. Design: Systematic review. Methods: A systematic review was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines using PubMed and Embase. The following search terms were used: knee osteoarthritis AND platelet rich plasma AND hyaluronic acid. The review was performed by 2 independent reviewers who applied the inclusion/exclusion criteria and independently extracted data, including methodologic scoring, PRP preparation technique, HA composition, and patient-reported outcomes (PROs). Results: A total of 431 articles were screened, 12 reviewed in full, and 8 included in the final analysis: 2 case series, 3 comparative, and 3 randomized studies. Average follow-up was 9 months. The modified Coleman Methodology Score was 38.13 ± 13.1 (mean ± SD). Combination therapy resulted in improved PROs in all studies. Of the comparative and randomized studies, 2 demonstrated that combination therapy was superior to HA alone. However, when PRP alone was used as the control arm (4 studies), combination therapy was not superior to PRP alone. Conclusion: Combination therapy with PRP + HA improves PROs and is superior to HA alone but is not superior to PRP alone.

scholarly journals In vitro responses to platelet-rich-plasma are associated with variable clinical outcomes in patients with knee osteoarthritis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Habib Zahir ◽  
Bijan Dehghani ◽  
Xiaoning Yuan ◽  
Yurii Chinenov ◽  
Christine Kim ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Clinical Outcomes ◽  
Inflammatory Responses ◽  
Platelet Rich Plasma ◽  
Autologous Blood ◽  
Limited Information ◽  
Knee Oa ◽  
Patient Reported ◽  
Treatment Comparisons

AbstractAutologous blood-derived products such as platelet-rich plasma (PRP) are widely used to treat musculoskeletal conditions, including knee osteoarthritis (OA). However, the clinical outcomes after PRP administration are often variable, and there is limited information about the specific characteristics of PRP that impact bioactivity and clinical responses. In this study, we aimed to develop an integrative workflow to evaluate responses to PRP in vitro, and to assess if the in vitro responses to PRP are associated with the PRP composition and clinical outcomes in patients with knee OA. To do this, we used a coculture system of macrophages and fibroblasts paired with transcriptomic analyses to comprehensively characterize the modulation of inflammatory responses by PRP in vitro. Relying on patient-reported outcomes and achievement of minimal clinically important differences in OA patients receiving PRP injections, we identified responders and non-responders to the treatment. Comparisons of PRP from these patient groups allowed us to identify differences in the composition and in vitro activity of PRP. We believe that our integrative workflow may enable the development of targeted approaches that rely on PRP and other orthobiologics to treat musculoskeletal pathologies.

scholarly journals Engagement and Participant Experiences With Consumer Smartwatches for Health Research: Longitudinal, Observational Feasibility Study (Preprint)

2019 ◽  
Author(s):  
Anna L Beukenhorst ◽  
Kelly Howells ◽  
Louise Cook ◽  
John McBeth ◽  
Terence W O'Neill ◽  
...  
Keyword(s):  
Data Collection ◽  
Knee Osteoarthritis ◽  
Patient Reported Outcomes ◽  
Health Data ◽  
Self Report ◽  
Sensor Data ◽  
Battery Life ◽  
Activity Data ◽  
Technical Problems ◽  
Patient Reported

BACKGROUND Wearables provide opportunities for frequent health data collection and symptom monitoring. The feasibility of using consumer cellular smartwatches to provide information both on symptoms and contemporary sensor data has not yet been investigated. OBJECTIVE This study aimed to investigate the feasibility and acceptability of using cellular smartwatches to capture multiple patient-reported outcomes per day alongside continuous physical activity data over a 3-month period in people living with knee osteoarthritis (OA). METHODS For the KOALAP (Knee OsteoArthritis: Linking Activity and Pain) study, a novel cellular smartwatch app for health data collection was developed. Participants (age ≥50 years; self-diagnosed knee OA) received a smartwatch (Huawei Watch 2) with the KOALAP app. When worn, the watch collected sensor data and prompted participants to self-report outcomes multiple times per day. Participants were invited for a baseline and follow-up interview to discuss their motivations and experiences. Engagement with the watch was measured using daily watch wear time and the percentage completion of watch questions. Interview transcripts were analyzed using grounded thematic analysis. RESULTS A total of 26 people participated in the study. Good use and engagement were observed over 3 months: most participants wore the watch on 75% (68/90) of days or more, for a median of 11 hours. The number of active participants declined over the study duration, especially in the final week. Among participants who remained active, neither watch time nor question completion percentage declined over time. Participants were mainly motivated to learn about their symptoms and enjoyed the self-tracking aspects of the watch. Barriers to full engagement were battery life limitations, technical problems, and unfulfilled expectations of the watch. Participants reported that they would have liked to report symptoms more than 4 or 5 times per day. CONCLUSIONS This study shows that capture of patient-reported outcomes multiple times per day with linked sensor data from a smartwatch is feasible over at least a 3-month period. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10238

scholarly journals End points for sickle cell disease clinical trials: patient-reported outcomes, pain, and the brain

2019 ◽  
Vol 3 (23) ◽  
pp. 3982-4001 ◽  
Author(s):  
Ann T. Farrell ◽  
Julie Panepinto ◽  
C. Patrick Carroll ◽  
Deepika S. Darbari ◽  
Ankit A. Desai ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Patient Reported Outcomes ◽  
Cell Disease ◽  
End Points ◽  
Additional Clinical Trial ◽  
Patient Reported ◽  
The Brain

Abstract To address the global burden of sickle cell disease (SCD) and the need for novel therapies, the American Society of Hematology partnered with the US Food and Drug Administration to engage the work of 7 panels of clinicians, investigators, and patients to develop consensus recommendations for clinical trial end points. The panels conducted their work through literature reviews, assessment of available evidence, and expert judgment focusing on end points related to: patient-reported outcomes (PROs), pain (non-PROs), the brain, end-organ considerations, biomarkers, measurement of cure, and low-resource settings. This article presents the findings and recommendations of the PROs, pain, and brain panels, as well as relevant findings and recommendations from the biomarkers panel. The panels identify end points, where there were supporting data, to use in clinical trials of SCD. In addition, the panels discuss where further research is needed to support the development and validation of additional clinical trial end points.

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