Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty
Condition: Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee; Arthroplasty, Replacement, Shoulder
Study type: Observational

Summary: 
      PaRIS-IOR is a prospective observational study that aims to collect and analyze functional
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR).
    

Detailed description: 
      PaRIS-IOR is a prospective observational study that aims to collect and analyze functional
      outcomes and quality of life reported by patients undergoing elective hip, knee and shoulder
      arthroplasty at the IRCCS Rizzoli Orthopedic Institute (IOR). IOR was selected as a pilot
      center for the launch of the OECD's PaRIS Initiative in Italy, whose purpose is to accelerate
      the adoption and reporting of validated, standardised, internationally-comparable
      patient-reported indicators, particularly within patient registries.

      PaRIS-IOR's study population will consist of consecutive patients undergoing hip, knee and
      shoulder arthroplasty performed at 6 Operative Units of the IOR. The study will last 30
      months and will include a 12-month recruitment period, a 12-month follow-up and 6 months for
      data analysis and reporting. Functional outcomes and quality of life will be detected through
      the administration of validated questionnaires (EQ-5D, HOOS, KOOS, ASES). The questionnaires
      will be administered in the month preceding the surgical procedure in the clinic or in the
      ward, while the 2 follow-up questionnaires will be send by mail at patients' home. The
      collected data will be combined with those routinely collected by the Registry of Orthopedic
      Prosthetic Implantology (RIPO), already active at the IOR since year 1990.
    

Intervention name(s): Questionnaire administration
Intervention type(s): Other
Intervention description(s): One questionnaire (Euro Quality 5 Dimensions, EQ-5D) for the general assessment of patient's health status will be administered to all the patients in the study. One joint-specific questionnaires will be administered to patients depending on the surgery procedure they will be undergoing. Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement (6); Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement (7); the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of consecutive patients undergoing hip, knee and shoulder
        arthroplasty. Patients will be enrolled at 6 operative units of the IOR (Orthopedic and
        Traumatological I Clinic, Orthopedic and Traumatological Clinic II, Orthopedic and
        Traumatologic Clinic III, Reconstructive Orthopedic Surgery - Innovative Techniques /
        Revision surgery of hip prosthesis and new implant development, Surgery of the Shoulder and
        Elbow, Orthopedics-Traumatology and Prosthetic Surgery and of hip and knee replanting). For
        patients accessing through the "hospitalization-before-surgery" pathway, the enrollment
        will take place in the specific ambulatory in the month preceding the intervention. The
        remaining patients will be enrolled directly at the operative Units involved.