Clinical trial NCT03790267: Functional Outcomes and Quality of Life in Hip, Knee and Shoulder Arthroplasty
Official title: Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Shoulder
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
Collaborators: name: University of Bologna
First posted: 2018-12-31
Enrollment: 4260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
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.

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Males and females aged 18-95 years
2. Be on the list for an elective primary arthroplasty of hip, knee or shoulder
3. Availability to sign the informed consent

Exclusion Criteria:

1. Severe cognitive impairment
2. To be listed for arthroplasty for musculoskeletal cancer
3. Not eligible for the surgical intervention

Primary outcomes:
measure: Functional outcomes: total score of the joint-specific functional scales.
timeFrame: Baseline
measure: Functional outcomes: total score of the joint-specific functional scales.
timeFrame: 6 months after surgery
measure: Functional outcomes: total score of the joint-specific functional scales.
timeFrame: 12 months after surgery
measure: Euro-Quality-5-Dimensions questionnaire scores.
timeFrame: Baseline
measure: Euro-Quality-5-Dimensions questionnaire scores.
timeFrame: 6 months after surgery
measure: Euro-Quality-5-Dimensions questionnaire scores.
timeFrame: 12 months after surgery
measure: Visual analogue scale (EQ-VAS) scores
timeFrame: Baseline
measure: Visual analogue scale (EQ-VAS) scores
timeFrame: 6 months after surgery
measure: Visual analogue scale (EQ-VAS) scores
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
Study officials:
References:
citation: Golinelli D, Grassi A, Tedesco D, Sanmarchi F, Rosa S, Rucci P, Amabile M, Cosentino M, Bordini B, Fantini MP, Zaffagnini S. Patient reported outcomes measures (PROMs) trajectories after elective hip arthroplasty: a latent class and growth mixture analysis. J Patient Rep Outcomes. 2022 Sep 9;6(1):95. doi: 10.1186/s41687-022-00503-5.
citation: Grassi A, Golinelli D, Tedesco D, Rolli M, Bordini B, Amabile M, Rucci P, Fantini MP, Zaffagnini S. Patient-reported outcome measures (PROMs) after elective hip, knee and shoulder arthroplasty: protocol for a prospective cohort study. BMC Musculoskelet Disord. 2019 Aug 15;20(1):374. doi: 10.1186/s12891-019-2745-3.