Vertebral fractures - is there a valid concept for (osteoporosis) treatment recommendation today?

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Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Background The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out.Peer reviewe

Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial

Background: The research objectives of the 5-year and 10-year assessments in the Finnish degenerative meniscal lesion study (FIDELITY) are twofold: (1) to assess the long-term efficacy of arthroscopic partial meniscectomy (APM) in adults (age 35 to 65 years) with a degenerative meniscus tear and (2) to determine the respective effects of APM and degenerative meniscus tear on the development of radiographic and clinical knee osteoarthritis (OA). Methods and design: FIDELITY is an ongoing multi-center, randomized, participant and outcome assessor blinded, placebo-surgery-controlled trial in 146 patients. This statistical analysis plan (SAP) article describes the overall principles for analysis of long-term outcomes (5-year and 10-year follow up), including how participants will be included in each analysis, the primary and secondary outcomes and their respective analyses, adjustments for covariates, and the presentation of the results. In addition, we will present the planned sensitivity and subgroup analyses. Discussion: To assess the long-term efficacy of APM on knee symptoms and function we are carrying out a long-term (5-year and 10-year) follow up of our placebo-surgery-controlled FIDELITY trial according to statistical principles outlined in detail in this document. As our second primary objective, whether APM (resection of torn meniscus tear) accelerates or delays the development of knee osteoarthritis in patients with an arthroscopically verified degenerative tear of the medial meniscus, a pre-registered follow-up is also carried out. Trial registration: ClinicalTrials.gov, NCT00549172 (Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear). Registered on 25 October 2007 (NCT00549172). ClinicalTrials.gov, NCT01052233 (Development of Knee Osteoarthritis After Arthroscopic Partial Resection of Degenerative Meniscus Tear). Registered on 20 January 2010.publishedVersionPeer reviewe

Arthroscopic partial meniscectomy versus placebo surgery for a degenerative meniscus tear : a 2-year follow-up of the randomised controlled trial

Objective To assess if arthroscopic partial meniscectomy (APM) is superior to placebo surgery in the treatment of patients with degenerative tear of the medial meniscus. Methods In this multicentre, randomised, participant-blinded and outcome assessor-blinded, placebo-surgery controlled trial, 146 adults, aged 35-65 years, with knee symptoms consistent with degenerative medial meniscus tear and no knee osteoarthritis were randomised to APM or placebo surgery. The primary outcome was the between-group difference in the change from baseline in the Western Ontario Meniscal Evaluation Tool (WOMET) and Lysholm knee scores and knee pain after exercise at 24 months after surgery. Secondary outcomes included the frequency of unblinding of the treatment-group allocation, participants' satisfaction, impression of change, return to normal activities, the incidence of serious adverse events and the presence of meniscal symptoms in clinical examination. Two subgroup analyses, assessing the outcome on those with mechanical symptoms and those with unstable meniscus tears, were also carried out. Results In the intention-to-treat analysis, there were no significant between-group differences in the mean changes from baseline to 24 months in WOMET score: 27.3 in the APM group as compared with 31.6 in the placebo-surgery group (between-group difference, -4.3; 95% CI, -11.3 to 2.6); Lysholm knee score: 23.1 and 26.3, respectively (-3.2; -8.9 to 2.4) or knee pain after exercise, 3.5 and 3.9, respectively (-0.4; -1.3 to 0.5). There were no statistically significant differences between the two groups in any of the secondary outcomes or within the analysed subgroups. Conclusions In this 2-year follow-up of patients without knee osteoarthritis but with symptoms of a degenerative medial meniscus tear, the outcomes after APM were no better than those after placebo surgery. No evidence could be found to support the prevailing ideas that patients with presence of mechanical symptoms or certain meniscus tear characteristics or those who have failed initial conservative treatment are more likely to benefit from APM.Peer reviewe

Olkapään sijoiltaanmeno

Vertaisarvioitu. Näin hoidan.Olkanivelen sijoiltaanmeno on yleisin suuren nivelen sijoiltaanmeno. Diagnoosi perustuu anamneesiin, kliiniseen tutkimukseen ja röntgenkuvantamiseen. Olkanivelen sijoiltaanmenon repositio edellyttää hyvää kivunhoitoa ja potilaan rentouttamista. Repositiotekniikoita on useita, eikä yksikään ole selvästi muita parempi. Reposition onnistuminen varmistetaan aina röntgenkuvauksella. Reposition jälkeen pyritään varhaiseen mobilisaatioon ja fysioterapeutin ohjaamaan kuntoutukseen. Ortopedin arvioon tulee ohjata ne potilaat, joiden nivel ei ole reposition jälkeen täysin paikallaan, joilla todetaan merkittävä dislokoitunut luunmurtuma tai joilla epäillään kiertäjäkalvosimen vammaa sekä ne, jotka ovat jatkossa erityisen alttiita uudelle sijoiltaanmenolle

Olkapään sijoiltaanmeno

Olkanivelen sijoiltaanmeno on yleisin suuren nivelen sijoiltaanmeno. Diagnoosi perustuu anamneesiin, kliiniseen tutkimukseen ja röntgenkuvantamiseen. Olkanivelen sijoiltaanmenon repositio edellyttää hyvää kivunhoitoa ja potilaan rentouttamista. Repositiotekniikoita on useita, eikä yksikään ole selvästi muita parempi. Reposition onnistuminen varmistetaan aina röntgenkuvauksella. Reposition jälkeen pyritään varhaiseen mobilisaatioon ja fysioterapeutin ohjaamaan kuntoutukseen. Ortopedin arvioon tulee ohjata ne potilaat, joiden nivel ei ole reposition jälkeen täysin paikallaan, joilla todetaan merkittävä dislokoitunut luunmurtuma tai joilla epäillään kiertäjäkalvosimen vammaa sekä ne, jotka ovat jatkossa erityisen alttiita uudelle sijoiltaanmenolle