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1.
Trials ; 20(1): 763, 2019 Dec 23.
Article in English | MEDLINE | ID: mdl-31870451

ABSTRACT

BACKGROUND: A 2014 Cochrane review evaluating the effect of anabolic steroids after hip fracture concluded that the quality of the studies was insufficient to draw conclusions on the effects and recommended further high-quality trials in the field. Therefore, the aim of this pilot trial is to determine the preliminary effect and feasibility of a 12-week multimodal intervention consisting of physiotherapy (with strength training), protein-rich nutritional supplement and anabolic steroid on knee-extension muscle strength and function 14 weeks after hip fracture surgery. METHODS: We plan to conduct a randomized, placebo-controlled pilot trial with 48 patients operated for acute hip fracture. The patients are randomized (1:1) to either (1) physiotherapy with protein-rich nutritional supplement plus anabolic steroid or (2) physiotherapy with protein-rich nutritional supplement plus placebo. Outcome assessments will be carried out blinded at baseline (3-10 days after surgery) and at 14 weeks after entering the trial. Primary outcome is the change from baseline to follow-up in maximal isometric knee-extension muscle strength in the fractured limb. Secondary outcomes are physical performance test, patient-reported outcomes, and measures of body composition. DISCUSSION: If the trial is found feasible and the results show an indication of anabolic steroid being a relevant addition to further enhance the recovery of muscle strength and function in an enhanced recovery after surgery program, this trial will constitute the basis of a larger confirmatory trial. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03545347. Preregistered on 4 June 2018.


Subject(s)
Anabolic Agents/therapeutic use , Dietary Proteins/therapeutic use , Dietary Supplements , Hip Fractures/rehabilitation , Muscle Strength , Nandrolone Decanoate/therapeutic use , Physical Therapy Modalities , Resistance Training/methods , Aged , Feasibility Studies , Hip Fractures/surgery , Humans , Middle Aged , Orthopedic Procedures/rehabilitation , Patient Reported Outcome Measures , Physical Functional Performance , Pilot Projects , Quadriceps Muscle
2.
Dan Med J ; 66(8)2019 08.
Article in English | MEDLINE | ID: mdl-31315794

ABSTRACT

INTRODUCTION: The treatment of choice for unstable diaphyseal fractures in the tibia is reamed insertion of an intramedullary nail (IMN). The most common complication to this treatment is chronic knee pain with reported rates ranging from 10% to 87% with a mean of 47.4% in meta-analyses. METHODS: This study evaluates the long-term outcome after IMN insertion in adult patients with a tibial shaft fracture using the Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire. The study includes patients operated on one of five Danish hospitals in a five-year period. The patients received a KOOS questionnaire with questions regarding knee-specific symptoms, stiffness, pain, function and quality of life. Data were subsequently compared to those of a reference population. RESULTS: A total of 391 patients were enrolled from the trauma centre's database search. 55 patients did not meet the inclusion criteria. Questionnaires were sent out to 336 patients and 223 (66%) responded. Mean age was 47.9 years at the time of surgery; 63% were men. The follow-up time ranged from 1.7 to 6.7 years. CONCLUSIONS: With a follow-up time of more than six years after receiving an IMN, patients in this study experienced more knee-specific symptoms, pain, limitations in sports and daily living than a reference population who had not undergone surgery. The study population also reported poorer quality of life outcomes than the reference population. FUNDING: none. TRIAL REGISTRATION: Approved by the Danish Data Protection Agency. Clinical trials: NCT03649360.


Subject(s)
Bone Nails , Fracture Fixation, Intramedullary , Knee Joint/physiopathology , Pain/etiology , Quality of Life , Tibial Fractures/surgery , Adolescent , Adult , Age Factors , Aged , Aged, 80 and over , Cross-Sectional Studies , Databases, Factual , Denmark , Female , Humans , Male , Middle Aged , Pain, Postoperative , Range of Motion, Articular , Retrospective Studies , Sex Factors , Surveys and Questionnaires , Tibial Fractures/complications , Treatment Outcome , Young Adult
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