Acute fragility fracture of the hip requiring surgical management Musculoskeletal Diseases
Conditions
Interventions
All participants will attend the DGHPU twice weekly for 12 weeks, for a supervised rehabilitation exercise intervention, with isolated, unilateral injured-leg exercises alone. The uninjured, unexercis
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Acute isolated hip fracture requiring operative intervention 2. Age =60 years old 3. Understands English 4. Able to give informed consent 5. Hip replacement surgery a criterion for collection of bone sample
Exclusion criteria
Exclusion criteria: 1. Ipsilateral knee replacement, tendon rupture, or patella fracture 2. History of neurological pathology, or stroke with motor function impairment 3. Evidence of impaired renal function (eGFR <30ml/min/1.73m²) 4. Diagnosis of Type 1 Diabetes Miletus 5. Rockwood Clinical Frailty Scale =5 6. BMI =40 kg/m² 7. Contraindication to NSAID therapy: i. History of hypersensitivity or allergy to ibuprofen (e.g., asthma, rhinitis, angioedema, urticaria) ii. History of asthma or hay fever with previous NSAID-associated exacerbation iii. History of Crohn’s disease or ulcerative colitis iv. History of haemorrhagic stroke v. Active or history of recurrent peptic ulcer/haemorrhage vi. History of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy vii. Severe heart failure (NYHA Class IV), severe renal failure or severe hepatic failure viii. Concomitant regular prescription of aspirin with a daily dose above 75 mg, or other non-steroidal anti-inflammatory medicine ix. Concomitant anticoagulant or antiplatelet prescription during study follow-up period (weeks 5-17 post-surgery)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Muscle mRNA gene expression measured using a custom TaqMan array at 5-, 9-, 13-, and 17-weeks post-operation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Isometric knee extension strength and isokinetic knee extension power and fatigability measured fortnightly using a Humac NORM dynamometer, at weeks 5, 7, 9, 11, 13, 15 and 17 post-operation. 2. Whole body and bilateral leg muscle volumes measured using whole-body MRI at weeks 4 and 17 post-operation 3. Muscle protein synthesis measured using D2O incorporation into skeletal muscle micro-biopsy specimens at 5-, 9-, 13-, and 17-weeks post-operation. 4. Muscle satellite cell number measured on microscopy of muscle micro-biopsy specimens at 5-, 9-, 13-, and 17-weeks post-operation. 5. Glucose disposal, measured via oral glucose tolerance test performed at weeks 5 and 17 post-operation 6. Handgrip strength measured using a Jamar handgrip dynamometer at weeks 0-2, 5, 11, and 17 post-operation. 7. Mobility and walking speed, measured using a 4-metre walk test at weeks 0-2, 5, 11 and 17 post-operation. 8. General patient-reported quality of life measured using the EQ5D-5L questionnaire at weeks 0 (baseline), 5, 17, and 26 post-operation. 9. Hip-specific pain and function measured using the Oxford Hip Score at weeks 0 (baseline), 5, 17, and 26 post-operation. 10. General disability level measured using the Disability Rating Index at weeks 0 (baseline), 5, 17, and 26 post-operation. 11. Level of cognitive impairment, using the Montreal Cognitive Assessment at baseline, and repeated at weeks 5 and 17 post-operation. 12. Serum concentration of inflammatory cytokines measured using proteomic analysis, at day 0 (pre-operative baseline), day 1-3, and week 17 post-operation. 13. Safety monitoring blood tests measured using FBC, U&E and LFT analyses of venous blood at baseline, and weeks 5, 8, 11, 14, and 17 post-operation. 14. Femoral head bone structure and density measured using micro-CT analysis of resected bone specimen, taken intraoperatively. 15. Gut microbiome composition measured using microbiome analyses of faecal specimen, collected on one occasion during the fir | — |
Countries
England, United Kingdom
Contacts
Public ContactChristopher Deacon
Outcome results
None listed