{"type":"trials","record":{"id":41206,"source_id":"clinicaltrials-gov","external_id":"NCT02443974","title":"Bracing to Treat Knee Osteoarthritis in Elderly","brief_summary":"Background: Osteoarthritis (OA) is highly prevalent in the elderly, with the knee being the most commonly affected joint in this population. Knee braces are often used to prevent common problems in knees during daily activities. The purpose of these devices is to decrease pain and improve functionality. In the literature some studies have tested the effectiveness of unloader brace for valgus or varus. However, the braces most used in the investigators' clinical setting and the less costly ones have not been described in quality studies in the literature. There are only few studies on this subject and they are methodologically inadequate. There are no studies that compared the effectiveness between the knee brace with metal hinges (no alignment) and knee brace without metal hinges. Objective: To evaluate the effectiveness of knee braces on pain, function and quality of life in the elderly with knee OA. Methods: Elderly with knee OA, both genders, with pain scale 3-7cm on a 10cm pain numeric scale were included. Of the 222 patients screened, 120 met the eligibility criteria and were randomized to the groups: without metal hinges, with metal hinges or control group. The groups without and with metal hinges received knee brace and were instructed to use it in daily activities, every day, during three months. Assessment for pain (NPS), function (WOMAC and Knee Lequesne) and quality of life (SF-36) were done at baseline and after 45, 90 and 180 days by a blinded assessor.","overall_status":"Completed","phases":["PHASE4"],"study_type":"INTERVENTIONAL","sponsor":"Federal University of São Paulo","enrollment":120,"countries":["Brazil"],"start_date":"2015-04-01","completion_date":"2016-03-01","last_update_date":"2016-07-01","source_url":"https://clinicaltrials.gov/study/NCT02443974","editorial_summary":"A registered PHASE4 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:25:26.536053+00:00","last_seen_at":"2026-09-25T03:10:58.794+00:00","metadata":{"acronym":null,"organization":"Federal University of São Paulo","source_has_results":false},"controlled_terms":["Knee Osteoarthritis","Brace (Fisiotensor®)","Sleeve (Fisiotensor®)"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":35,"publication_state":"published","match_explanation":"Title contains controlled term: osteoarthritis.","quality_checked_at":"2026-09-25T03:11:01.385369+00:00","duplicate_cluster_key":"id:nct02443974","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2015-04-01 to 2016-03-01","comparator":null,"confidence":"structured-source","population":null,"provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T03:39:00.171371+00:00","intervention":[],"participants":120,"study_design":"INTERVENTIONAL","subject_scope":"Human clinical study registration","evidence_stage":"PHASE4","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":[],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"joint-cartilage-aging","is_published":true,"match_reasons":["Title contains controlled term: osteoarthritis.","Abstract contains controlled term: osteoarthritis.","Source terminology contains: osteoarthritis.","Title supplies longevity context: elderly.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Joint and cartilage ageing","slug":"joint-cartilage-aging"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/41206","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}