Hypothesis
Null Hypothesis: There will be no change compared with pre-intervention baseline data.
Summary
This study will compare the pre-operative scores to outcomes at six months, one, two and five years, ten years, and beyond. Individuals will act as their own controls using a repeated measures design. Data will also be compared to an age and gender-matched amputee population and an age and gender-matched uninjured population.
- The research team will collect demographic and descriptive data including age, weight, height, body mass index (adjusted for amputees), mechanism of injury, time since injury, smoking status, other sustained injuries, and medication history.
- The following validated questionnaires will be used to obtain the subjective patient-focused outcomes: EQ 5D, Short form 36 (SF-36), Questionnaire for transfemoral amputees (Q-TFA), Prosthetic Satisfaction Questionnaire, SIGAM (Mobility) Questionnaire, KOOS Knee Survey, Oswestry Low Back Pain Disability Questionnaire, PHQ-9 (depression) and GAD-7 (anxiety).
- Functional data will consist of 6 Minute Walk Test (6MWT), Timed Up and Go (TUG) and Gait Analysis.
- Dual Energy X-ray Absorptiometry (DEXA) scanning will be utilized to assess for changes in bone mineral density. Data will be collected prospectively. If data is found to be missing or not collected at the appropriate time point with patient consent and appropriate governance clearance other repositories i.e. NHS health records will be accessed to see if missing data can be extracted from other sources. Please note that some of the follow-ups align with the ADVANCE study data point, and other follow-ups take place at Imperial College, so this will combine the data from these two datasets.
Keywords
TF-DSF, PROMS, Implant survival, Bone density