Background
: Osteoarthritis is most prevalent in the knee and drives the growing incidence of total knee arthroplasty. There is a need to explore non-surgical treatment options to increase the ...portfolio of alternatives available. The study aimed to determine the clinical response to an autologous bone marrow aspirate concentrate (BMAC) and platelet-rich plasma (PRP) intra-articular injection compared to an active comparator.
Methods
: The study was a prospective, single-blinded, randomized controlled pilot study. Participants with diagnosed knee osteoarthritis were allocated to one of two treatment groups to receive a BMAC injection immediately followed by a PRP injection or a single injection of Gel-One® crosslinked hyaluronate (HA). Outcomes were assessed at 3, 6, and 12 months post-treatment.
Results
: Significant improvements were observed in both treatment groups for all Knee Injury and Osteoarthritis Outcome Score (KOOS) subscales with the exception of the symptoms assessment at 12 months in the HA group. BMAC KOOS scores peaked at 12 months, while HA KOOS scores generally peaked at 6 months. The gap in mean scores at 12 months in favor of the BMAC group did not reach statistical significance. Secondary outcomes included a greater reduction in pain at 12 months in the BMAC group (-3.13 points; 95% CI: -3.96, -3.29) compared to the HA group (-1.56 points; 95% CI: -2.59, -0.53; p= 0.02) via the numeric pain rating scale.
Conclusions
: Results demonstrate that both treatment groups experienced clinically and statistically significant improvement across the KOOS subscales. While BMAC has shown promise in the treatment of knee OA, there is a need for multi-center investigations with larger sample sizes, an extended follow-up, and placebo-based control. ClinicalTrials.gov Identifier: NCT02958267
The contributors to this volume show that the themes of empire, colony, and national liberation movements can be addressed in a European continental as much as in Asian, Latin American, or African ...contexts. There is a further benefit from a within-Europe comparison: It calls into question the tendency to assume fundamental differences between “western” and “eastern” Europe, including the now largely abandoned distinction between a “western” nationalism, defined as a civil nationalism, and an “eastern” one, defined as ethnic. It also answers the question whether intra-European comparison of this kind is possible, in a context where post-Soviet scholarship is often invisible in Anglo-American scholarship. As Norman Davies reminds us, low public awareness of Europe’s smaller and, in west-European minds, “more distant” nations, underlies the persistence of false generalizations about them, including assumptions like “that the whole of the west was advanced while the whole of the east was backward.”
Introduction
Osteoarthritis (OA) is common and its prevalence is increased in military service members. In a phase 3 randomized controlled trial (NCT02357459), a single intra-articular injection of ...an extended-release formulation of triamcinolone acetonide (TA-ER) in participants with unilateral or bilateral knee OA demonstrated substantial improvement in pain and symptoms. Bilateral knee pain has emerged as a confounding factor in clinical trials when evaluating the effect of a single intra-articular injection. Furthermore, unilateral disease is frequently first to emerge in active military personnel secondary to prior traumatic joint injury. In this post hoc analysis, we assessed efficacy and safety of TA-ER in a subgroup of participants with unilateral knee OA.
Methods
Participants ≥ 40 years of age with symptomatic knee OA were randomized to a single intra-articular injection of TA-ER 32 mg, TA crystalline suspension (TAcs) 40 mg, or saline-placebo. Average daily pain (ADP)-intensity and rescue medication use were collected at each of weeks 1–24 postinjection; Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-A (pain), WOMAC-B (stiffness), WOMAC-C (function), and Knee Injury and Osteoarthritis Outcome Score Quality of Life (KOOS-QoL) were collected at weeks 4, 8, 12, 16, 20, and 24 postinjection. Adverse events (AEs) were assessed throughout the study. Participants with unilateral knee OA were selected for this analysis.
Results
Of 170 participants with unilateral OA (TA-ER,
N
= 51; saline-placebo,
N
= 60; TAcs,
N
= 59), 42% were male and 89% were white. TA-ER significantly (
p
< 0.05) improved ADP-intensity vs. saline-placebo (weeks 1–24) and TAcs (weeks 4–21). TA-ER significantly (
p
< 0.05) improved WOMAC-A vs. saline-placebo (all time points) and TAcs (weeks 4, 8, 12, 24). Consistent outcomes were observed for rescue medication, WOMAC-B, WOMAC-C, and KOOS-QoL. AEs were similar in frequency/type across treatments.
Conclusion
TA-ER provided 5–6 months’ pain relief that consistently exceeded saline-placebo and TAcs, suggesting that TA-ER injected intra-articularly into the affected knee may be an effective non-opioid treatment option. Although the participants included in this analysis did not fully represent the diverse demographics of active service members, the substantial unmet medical need in the military population suggests that TA-ER may be an important treatment option; additional studies of TA-ER in active military patients are needed.
Trial Registration
ClinicalTrials.gov NCT02357459.
Funding
Flexion Therapeutics, Inc.
Plain Language Summary
Plain language summary available for this article.
Introduction
Evidence‐based guidelines suggest a conservative, nonsurgical approach as first‐line treatment for knee osteoarthritis. However, previous literature has documented underutilization of ...the fundamental components of condition management emphasized in the guidelines. The intervention aim is to apply organized conservative components of care for knee osteoarthritis in an evidence‐based management program through the translation of research into practice with a target to observe meaningful functional improvement in a distinct population.
Methods
The program, modeled after the nonsurgical arm of a randomized, controlled trial, was designed as a single‐arm observational cohort study with a pre‐ and post‐program comparison for participants reporting presence of knee osteoarthritis who were attributed to a specific employer's health plan in the United States. The 12‐week intervention consisted of condition education, group exercise, and a dietary intervention.
Results
Ninety‐six participants enrolled in the program, of which 72% completed the protocol. The median change in pre‐ to post‐program Knee Injury and Osteoarthritis Outcome Score values was 10.4 ± 0.8 (Z = 210.5, p < 0.001)—a clinically important change. Secondary outcomes were complementary to the primary outcome.
Conclusions
Results of the program indicate that the clinically significant 3‐month findings in the report by Skou et al. (2015) regarding functional improvement can be replicated in an alternate setting. Organizing and offering fundamental components of condition management in a group format with provider oversight could be a feasible and logical component in the continuum of care for knee osteoarthritis, while complementing other secondary management strategies following diagnosis.
Ireland's Catholic-Protestant conflict rests on multiple, overlapping differences: religious, ethnic, colonial, political. To better understand it, and in particular its religious aspect, I trace ...Europe's long Catholic-Protestant conflict, how it began, reproduced itself over time, and finally came to an end in the twentieth century. I then use this to generate insights into Ireland's long conflict, how it began, how it developed, why it ended in the Republic, why it has continued in Northern Ireland, and how the latter conflict might end.
Shoulder Injury-Baseball Dockry, Andrea; Strakowski, Jeffrey; Ruane, Joseph
Medicine and science in sports and exercise,
8/2021, Volume:
53, Issue:
8S
Journal Article
This volume focuses on a number of research questions, drawn from social movement scholarship: How does nonviolent mobilisation emerge and persist in deeply divided societies? What are the ...trajectories of participation in violent groups in these societies? What is the relationship between overt mobilisation, clandestine operations and protests among political prisoners? What is the role of media coverage and identity politics? Can there be non-sectarian collective mobilisation in deeply divided societies? The answers to these questions do not merely try to explain contentious politics in Northern Ireland; instead, they inform future research on social movements beyond this case. Specifically, we argue that an actor-based approach and the contextualisation of contentious politics provide a dynamic theoretical framework to better understand the Troubles and the development of conflicts in deeply divided societies.
The recent literature on path dependence provides a model that can be used in explanation of ethnic conflict and settlement processes. Using Northern Ireland as a case study, this article identifies ...path dependent patterns of conflict embedded in long-term processes of political development whose change may interrupt these patterns. It highlights the importance of long-term state trajectories in constituting and reproducing these patterns, the generation of ‘endogenous’ processes of change and the impact of wider geopolitical processes in strengthening these. It shows how and why factors such as power, perception, networks and institutions vary in their impact on conflict and explains when they work together to produce settlement.
This article argues for a historical-structural approach to explaining conflict and settlement. It argues that the manner in which institutions function and actors pursue their ends is in part ...determined by slow-moving interlinked structural relationships whose logic, trajectory and effects can only be identified historically. In complex conflicts such structural configurations generate tendencies to conflict and settlement requires that they be weakened. The article elaborates this model to account for settlement in Northern Ireland. It argues that what made the difference between relative success in the Good Friday Agreement of 1998 and earlier failures was not short-term actor-oriented mechanisms, or even a lessening of structural inequality alone, but change in a deeper structural configuration, triggered by a change in the role of the British state. The article traces how this was taken forward, and explains why tensions continue. It contributes to debates on the role of political agency and structural constraint in complex conflicts.
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