| 1. |
- Watt, F. E., et al.
(författare)
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Towards prevention of post-traumatic osteoarthritis : report from an international expert working group on considerations for the design and conduct of interventional studies following acute knee injury
- 2019
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 27:1, s. 23-33
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Tidskriftsartikel (refereegranskat)abstract
- Objective: There are few guidelines for clinical trials of interventions for prevention of post-traumatic osteoarthritis (PTOA), reflecting challenges in this area. An international multi-disciplinary expert group including patients was convened to generate points to consider for the design and conduct of interventional studies following acute knee injury. Design: An evidence review on acute knee injury interventional studies to prevent PTOA was presented to the group, alongside overviews of challenges in this area, including potential targets, biomarkers and imaging. Working groups considered pre-identified key areas: eligibility criteria and outcomes, biomarkers, injury definition and intervention timing including multi-modality interventions. Consensus agreement within the group on points to consider was generated and is reported here after iterative review by all contributors. Results: The evidence review identified 37 studies. Study duration and outcomes varied widely and 70% examined surgical interventions. Considerations were grouped into three areas: justification of inclusion criteria including the classification of injury and participant age (as people over 35 may have pre-existing OA); careful consideration in the selection and timing of outcomes or biomarkers; definition of the intervention(s)/comparator(s) and the appropriate time-window for intervention (considerations may be particular to intervention type). Areas for further research included demonstrating the utility of patient-reported outcomes, biomarkers and imaging outcomes from ancillary/cohort studies in this area, and development of surrogate clinical trial endpoints that shorten the duration of clinical trials and are acceptable to regulatory agencies. Conclusions: These considerations represent the first international consensus on the conduct of interventional studies following acute knee joint trauma.
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| 2. |
- Struglics, A., et al.
(författare)
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Molecular and imaging biomarkers of local inflammation at 2 years after anterior cruciate ligament injury do not associate with patient reported outcomes at 5 years
- 2020
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 28:3, s. 356-362
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To estimate the association between molecular or imaging inflammatory biomarkers at 2 years after anterior cruciate ligament (ACL) injury and patient-reported outcomes at 5 years. Methods: For 116 ACL-injured patients, molecular biomarkers of inflammation (synovial fluid and serum cytokines) and Hoffa- and effusion-synovitis as visualized on magnetic resonance imaging (MRI) were assessed 2 years post-injury. Knee injury and Osteoarthritis Outcome Score (KOOS) and SF-36 were assessed at 2 and 5 years. We used multiple imputation to handle biomarker values that were below the level of detection or missing, and linear regression for statistical analyses. Results: None of the synovial fluid cytokines or imaging biomarkers of inflammation at 2 years were associated with any of the patient-reported outcomes at 5 years. With each log10 unit higher of serum tumor necrosis factor concentration the knee-related quality of life of KOOS was increased (i.e., better outcome) by 35 (95% confidence interval 7 to 63) points. No other serum biomarker measured at 2 years was associated with patient-reported outcome at 5 years. Conclusion: Local joint inflammation assessed by biomarkers in synovial fluid and Hoffa- and effusion-synovitis on MRI at 2 years after an ACL injury did not associate with patient-reported outcomes at 5 years. Thus, chronic inflammation in the ACL-injured knee, as reflected by the biomarkers studied here, seems not to be a key determinant for the long-term patient-reported outcomes.
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| 3. |
- Abbott, Allan, 1978-, et al.
(författare)
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Understanding the role of diabetes in the osteoarthritis disease and treatment process: a study protocol for the Swedish Osteoarthritis and Diabetes (SOAD) cohort
- 2019
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 9:12
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Tidskriftsartikel (refereegranskat)abstract
- Introduction Osteoarthritis (OA) is the most common form of arthritis and a leading cause of disability worldwide. Metabolic comorbidities such as type II diabetes occur with a higher rate in people with OA than in the general population. Several factors including obesity, hyperglycaemia toxicity and physical inactivity have been suggested as potential links between diabetes and OA, and have been shown to negatively impact patients' health and quality of life. However, little is known on the role of diabetes in determining the outcome of non-surgical and surgical management of OA, and at the same time, how different OA interventions may affect diabetes control. Thus, the overall aim of this project is to explore (1) the impact of diabetes on the outcome of non-surgical and surgical OA treatments and (2) the impact of non-surgical and surgical OA treatments on diabetes control. Methods and analysis The study cohort is based on prospectively ascertained register data on a national level in Sweden. Data from OA patients who received a first-line non-surgical intervention and are registered in the National Quality Register for Better Management of Patients with Osteoarthritis will be merged with data from the Swedish Knee and Hip Arthroplasty Registers and the National Diabetes Register. Additional variables regarding patients' use of prescribed drugs, comorbidities, socioeconomic status and cause of death will be obtained through other national health and population data registers. The linkage will be performed on an individual level using unique personal identity numbers. Ethics and dissemination This study received ethical approval (2019-02570) from the Swedish Ethical Review Authority. Results from this cohort will be submitted to peer-reviewed scientific journals and reported at the leading national and international meetings in the field.
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| 4. |
- Englund, M, et al.
(författare)
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Patient-relevant outcomes fourteen years after meniscectomy : influence of type of meniscal tear and size of resection
- 2001
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Ingår i: Rheumatology. - : Oxford University Press (OUP). - 1462-0332 .- 1462-0324. ; 40:6, s. 631-639
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVES: To study long-term patient-relevant outcomes after meniscectomy, a surgical procedure associated with a high risk of knee osteoarthritis (OA). Principal objectives were to compare traumatic with degenerative meniscal tear and partial with subtotal meniscectomy.METHODS: We studied a well-defined cohort of 205 patients who had undergone isolated unilateral meniscectomy between 1983 and 1985. There was no previous knee surgery and all knees were stable. The type of meniscal tear and surgical resection was ascertained by review of medical records. Patients were followed up after 14 yr (range 12-15 yr) by self-administered questionnaires, one generic [Short Form 36 (SF-36)] and one disease-specific [Knee Injury and Osteoarthritis Outcome Score (KOOS)].RESULTS: In a multivariate analysis, using the Sports and Recreation Function and knee-related Quality of Life subscales of the KOOS questionnaire as dependent variables, patients with a degenerative tear scored significantly worse than individuals with a traumatic tear (P < or = 0.001). When we analysed unmatched subgroups and age- and sex-matched patients with degenerative or traumatic lesions, the same result was found for the knee-specific outcome (P < or = 0.02) and SF-36 except for Social Functioning (P < or = 0.04). There was no difference in outcome for the total cohort according to the type of resection. However, subgroup analyses showed that patients who underwent subtotal meniscectomy for a degenerative tear scored significantly worse on the knee-specific outcome than individuals who had had a partial meniscectomy for the same type of tear (P < or = 0.02).CONCLUSIONS: The long-term outcome of meniscal injury and surgery appears to be determined largely by the type of meniscal tear. Furthermore, our findings support the use of minimal meniscal resection in the treatment of degenerative tears. We suggest that the disease processes associated with the development of OA of the joint cartilage may also be active in the meniscus, and that a tear in a meniscus with degenerative changes might be regarded as the first sign of OA of the joint.
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| 5. |
- King, L. K., et al.
(författare)
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“You don't put it down to arthritis” : A qualitative study of the first symptoms recalled by individuals with knee osteoarthritis
- 2024
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Ingår i: Osteoarthritis and Cartilage Open. - 2665-9131. ; 6:1
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Tidskriftsartikel (refereegranskat)abstract
- Objective: As part of the first phase of the OARSI Early-stage Symptomatic Knee Osteoarthritis (EsSKOA) initiative, we explored the first symptoms and experiences recalled by individuals with knee osteoarthritis (OA). Design: This qualitative study, informed by qualitative description, was a secondary analysis of focus groups (n = 17 groups) and one-on-one interviews (n = 3) conducted in 91 individuals living with knee OA as part of an international study to better understand the OA pain experience. In each focus group or interview, participants were asked to describe their first symptoms of knee OA. We inductively coded these transcripts and conducted thematic analysis. Results: Mean age of participants was 70 years (range 47–92) and 68 % were female. We developed four overarching themes: Insidious and Episodic Onset, Diverse Early Symptoms, Must be Something Else, and Adjustments. Participants described the gradual and intermittent way in which symptoms of knee OA developed over many years; many could not identify a specific starting point. Participants described diverse initial knee symptoms, including activity-exacerbated joint pain, stiffness and crepitus. Most participants dismissed early symptoms or rationalized their presence, employing various strategies to enable continued participation in recreational and daily activities. Few sought medical attention until physical functioning was demonstrably impacted. Conclusions: The earliest symptoms of knee OA are frequently insidious in onset, episodic and present long before individuals present to health professionals. These results highlight challenges to identifying people with knee OA early and support the development of specific classification criteria for EsSKOA to capture individuals at an early stage.
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| 6. |
- Kraus, V B, et al.
(författare)
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OARSI Clinical Trials Recommendations: Soluble biomarker assessments in clinical trials in osteoarthritis.
- 2015
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 23:5, s. 686-697
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Forskningsöversikt (refereegranskat)abstract
- The objective of this work was to describe requirements for inclusion of soluble biomarkers in osteoarthritis (OA) clinical trials and progress toward OA-related biomarker qualification. The Guidelines for Biomarkers Working Group, representing experts in the field of OA biomarker research from both academia and industry, convened to discuss issues related to soluble biomarkers and to make recommendations for their use in OA clinical trials based on current knowledge and anticipated benefits. This document summarizes current guidance on use of biomarkers in OA clinical trials and their utility at five stages, including preclinical development and phase I to phase IV trials. As demonstrated by this summary, biomarkers can provide value at all stages of therapeutics development. When resources permit, we recommend collection of biospecimens in all OA clinical trials for a wide variety of reasons but in particular, to determine whether biomarkers are useful in identifying those individuals most likely to receive clinically important benefits from an intervention; and to determine whether biomarkers are useful for identifying individuals at earlier stages of OA in order to institute treatment at a time more amenable to disease modification.
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| 7. |
- Macri, E. M., et al.
(författare)
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Importance of patellofemoral and tibiofemoral cartilage lesions on trajectory of self-reported outcomes in patients at high risk of knee OA : 4–6 years follow-up of patients undergoing meniscal surgery
- 2021
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 29:9, s. 1291-1295
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Tidskriftsartikel (refereegranskat)abstract
- Objective: We evaluated whether patient-reported outcome trajectories (i.e., changes over time) differed by intraoperative compartmental cartilage lesion pattern over 4–6 years following arthroscopic meniscal surgery. Methods: In this ancillary study of the Knee Arthroscopy Cohort Southern Denmark cohort, we intraoperatively categorized cartilage lesions as isolated patellofemoral, isolated tibiofemoral, or combined patellofemoral/tibiofemoral. Participants completed the Knee injury and Osteoarthritis Outcome Score (KOOS) pre-operatively, at 3 and 12 months, and at 4–6 years post-operatively and reported overall satisfaction at final follow-up. Our main outcome was KOOS4 (grand mean of four subscale means). We evaluated whether KOOS4 scores changed over time according to cartilage lesion patterns using adjusted mixed linear regression. We also estimated probability of treatment satisfaction using logistic regression. Results: Of 630 participants with complete cartilage scores, 280 (44%) were women, mean (standard deviation) age was 49 (13) years, and BMI was 27.3 (4.4) kg/m2. KOOS4 scores at baseline were slightly lower in all lesion groups compared to the no lesion group, yet only the combined group was statistically significantly lower. KOOS4 trajectories were similar across cartilage lesion patterns, but by final follow-up, adjusted mean KOOS4 scores were 6.8 (95% CI 2.2, 11.4) to 9.8 (1.1, 18.5) points lower in groups with cartilage lesions compared to the no lesion group. Probability of patient-reported satisfaction did not differ statistically by group. Conclusions: Though KOOS4 scores were slightly lower in groups with arthroscopically assessed cartilage lesions compared to the no lesion group, trajectories were similar across all groups.
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| 8. |
- Michaëlsson, Karl, 1959-, et al.
(författare)
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Association between statin use and consultation or surgery for osteoarthritis of the hip or knee : a pooled analysis of four cohort studies.
- 2017
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584 .- 1522-9653. ; 25:11, s. 1804-1813
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Experimental findings and previous observational data have suggested lower risk of osteoarthritis (OA) with statin use but results are inconsistent. Large-scale studies with a clinically important outcome are needed. Thus, we aimed to determine whether statin use is associated with a reduced risk of developing clinically-defined hip or knee OA.DESIGN: Pooled analysis based on time-to-event analysis of four population-based large cohorts, encompassing in total 132,607 persons aged 57-91 years resident in southern and central Sweden. We studied the association between statin use and time to consultation or surgery for OA of the hip or knee by time-dependent exposure analysis and Cox regression.RESULTS: During 7.5 years of follow-up, we identified 7468 out- or inpatient treated cases of hip or knee OA. Compared with never use, current use of statins conferred no overall reduction in the risk of OA with an adjusted pooled hazard ratio (HR) of 1.04 (95% confidence intervals [95% CI] 0.99-1.10). We found no dose-response relation between duration of current statin use and the risk of OA, with similar HRs among patients with less than 1 year of use (HR 1.09; 95% CI 0.92-1.32) as in patients with use for 3 years or more (HR 1.05; 0.93-1.16). Results were comparable in those with low, medium and high dose of current statin use, without indications of heterogeneity of study results.CONCLUSION: Statin use is not associated with reduced risk of consultation or surgery for OA of the hip or knee.
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| 9. |
- Pihl, K., et al.
(författare)
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Change in patient-reported outcomes in patients with and without mechanical symptoms undergoing arthroscopic meniscal surgery : A prospective cohort study
- 2018
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 26:8, s. 1008-1016
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Patients with degenerative or traumatic meniscal tears are at high risk of developing knee osteoarthritis. We investigated if younger (≤40 years) and older (>40 years) patients with preoperative mechanical symptoms (MS) improved more in patient-reported outcomes after meniscal surgery than those without MS. Design: Patients from Knee Arthroscopy Cohort Southern Denmark (KACS) undergoing arthroscopic surgery for a meniscal tear completed online questionnaires before surgery, and at 12 and 52 weeks follow-up. Questionnaires included self-reported presence of MS (i.e., sensation of catching and/or locking) and the Knee injury and Osteoarthritis Outcome Score (KOOS). We analyzed between-group differences in change in KOOS4 from baseline to 52 weeks, using an adjusted mixed linear model. Results: 150 younger patients (mean age 31 (SD 7), 67% men) and 491 older patients (mean age 54 (SD 9), 53% men) constituted the baseline cohorts. Patients with MS generally had worse self-reported outcomes before surgery. At 52 weeks follow-up, younger patients with preoperative MS had improved more in KOOS4 scores than younger patients without preoperative MS (adjusted mean difference 10.5, 95% CI: 4.3, 16.6), but did not exceed the absolute postoperative KOOS4 scores observed for those without MS. No difference in improvement was observed between older patients with or without MS (adjusted mean difference 0.7, 95% CI: −2.6, 3.9). Conclusions: Younger patients (≤40 years) with preoperative MS experienced greater improvements after arthroscopic surgery compared to younger patients without MS. Our observational study result needs to be confirmed in randomized trials.
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| 10. |
- Snoeker, B. A.M., et al.
(författare)
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Is meniscal status in the anterior cruciate ligament injured knee associated with change in bone surface area? An exploratory analysis of the KANON trial
- 2021
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Ingår i: Osteoarthritis and Cartilage. - : Elsevier BV. - 1063-4584. ; 29:6, s. 841-848
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To study bone shape changes as a potential early feature of post-traumatic structural knee OA development, we estimated the association between meniscal status in the anterior cruciate ligament (ACL) injured knee and longitudinal condyle changes in bone surface area. Design: We used data from the KANON trial, including 121 young ACL-injured adults. We obtained baseline and 2-year follow-up knee MRIs. Our outcome was change in the bone surface areas (mean mm2, log-transformed) in 4 locations (femur, tibia, patella, and trochlea femur) in the medial and lateral compartment from baseline to 2 years. Meniscal pathology was defined as both present at baseline and newly developed (i.e., incident or progressed) using ACLOAS. We used multilevel linear regression adjusted for baseline bone area, age, sex, body mass index, treatment arm (i.e., early or optional delayed ACL reconstruction), and location. We analyzed medial and lateral compartment separately. We present results as percentage (%) bone area change difference with 95% confidence intervals (CI). Results: We analyzed 109 subjects (median 27 (18–36) years, 83% men) due to missing MRI information. The bone surface area increased on average by ∼2% over 2 years. The differences between knees with and without baseline meniscal pathology were 1.1% (95%CI 0.0–2.3%) and 1.4% (95%CI 0.6–2.2%) in the medial and lateral compartment, respectively, and 1.2% (95%CI 0.3–2.0%) and 1.3% (95%CI 0.6–2.0%) for medial and lateral newly developed pathology, respectively. Conclusion: Our finding of ∼1% increase bone area in compartment with meniscal pathology suggests a potentially important association between meniscal integrity and early bone surface area changes after ACL injury. Trial registration number ISRCTN 84752559.
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