Go Fit Fast, Recovery Trajectory Using PROMIS®, Linking PROMIS®

Condition(s) studied

Investigational drug(s) / intervention(s)

All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.: All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.

Study summary

Prospective data will be collected in approximately 3500 patients (700 per 5 injury groups).

Patients will be followed up according to the standard (routine) for up to 1 year after the treatment.

Data collection will include underlying disease, treatment details, patient reported outcomes (PROs), anticipated or procedure-related adverse events (i.e. complications), and radiological outcomes.

Eligibility

Primary outcome measure(s)

• Go Fit Fast: Radiographic measurements, Patient related outcomes (PROs: PROMIS, HOOS, KOOS,), Loading/Activity pattern analysis — from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
  * Radiographic measurements o Healing (Radiographic Union Score in Tibia Fractures \[RUST\]/ Radiographic Union Score in Hip Fractures \[RUSH\]) * Patient related outcomes * Patient Reported Outcome Measurement Information System (PROMIS): Physical Function (PF) short form Custom AO14 Pain Interference * Hip Disability and Osteoarthritis Outcome Score (HOOS-12) (assessing short- and long-term symptoms and function in hip injuries; the lower score indicates higher symptoms) * Knee Injury and Osteoarthritis Outcome Score (KOOS-12) (assessing short- and long-term symptoms and function in knee injuries; the lower score indicates higher symptoms) * Loading/Activity pattern analysis: * Number of steps with weight-bearing \>80% body-weight (weight in kg) * pressure distribution \[N/cm2\] * center of pressure \[mm\] * ground reaction forces \[N\] * temporal and spatial parameters (time spent during gait \[min\], stance time \[s\], swing time \[s\], double support time \[s\], cadence \[r/min\], cycle time \[s\])
• Recovery Trajectories PROMIS/Linking PROMIS: PROs: PROMIS, HOOS, KOOS, QuickDASH, FAAM — from the pre-treatment assessment until 12 months after the treatment (surgical or not-surgical)
  PROs that measure physical limitations: * PROMIS PF Short Form Custom AO14 (questions that cover the domain of physical function/mobility from self-care to strenuous activities) * PROMIS Upper Extremity (UE) Short Form Custom AO8 (questions assessing arm and hand specific limitations, e.g. difficulty writing, lifting heavy objects; a higher score indicates a better function) * Disabilities of the Arm, Shoulder, and Hand (QuickDASH) (11 questions assessing outcomes in upper extremity disorders; a higher score indicates a greater disability) * HOOS-12 * KOOS-12 * Foot and Ankle Ability Measure (FAAM) (21 items of activities of daily living subscale) * PROMIS Global Health (10 questions assessing physical health, mental health, and social health; a higher score indicates a better general health)

Trial sites (15)

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