Functional Outcomes and Quality of Life Reported by Adult Patients Undergoing Elective Hip, Knee and Shoulder Arthroplasty
Conditions: Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Arthroplasty, Replacement, Shoulder
Sponsor: Istituto Ortopedico Rizzoli

 
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STUDY PROTOCOL 
Functional outcomes and quality of life reported by adult patients undergoing 
elective hip, knee and shoulder arthroplasty (PaRIS-IOR) 
Study acronym 
PaRIS - IOR 
Promoter 
Istituto Ortopedico Rizzoli 
Via di Barbiano 1/10 
40136 Bologna 
Italia 
Protocol version 
Vers 1.0 
November 29, 2018 
Principal Investigator 
Prof. Stefano Zaffagnini 
Clinica Ortopedica Traumatologica II 
Phone :+39 051-6366.520 
Email:stefano.zaffagnini@unibo.it 
Co-investigators  
-Cesare Faldini, Clinica Ortopedica Traumatologica I-IOR 
-Dante Dallari, Chirurgia Ortopedica Ricostruttiva e tecniche 
innovative IOR 
-Francesco Traina, Ortopedia–traumatologia e chirurgia 
protesica e dei reimpianti d’anca e di ginocchio- IOR 
-Davide Maria Donati, Clinica Ortopedica Traumatologica III 
a prevalente  indirizzo oncologico- IOR 
-Roberto Rotini, Chirurgia della spalla e del gomito- IOR 
-Susanna Stea, Laboratorio di tecnologia medica IOR 
-Barbara Bordini, Registro della Implantologia Protesica 
Ortopedica (R.I.P.O.)- IOR 
-Maria Pia Fantini, Unità di supporto metodologico e 
statistico alla ricerca biomedica e sui servizi sanitari-
DIBINEM University of Bologna  
-Paola Rucci, Unità di supporto metodologico e statistico alla 
ricerca biomedica e sui servizi sanitari-DIBINEM University 
of Bologna  
Study design 
Prospective cohort study 
Type 
Academic / non-profit, monocentric, national 
Financing 
Independent/autonomous funding 
 
 
 

 
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BACKGROUND 
The World Health Organization (WHO) has recently defined patient centeredness as a 
fundamental characteristic for the quality of health care (1). Patient centeredness can be 
measured through the collection of functional outcomes and quality of life reported by 
patients, the so-called Patient-Reported Outcome Measures (PROMs). The Organization 
for Economic Cooperation and Development (OECD) has launched an initiative (called 
PaRIS Initiative) for the systematic collection of PROMs in patients undergoing elective hip 
and knee prosthetic arthroplasty 6 and 12 months after surgery (2). Such data is already 
routinely collected in several OECD member countries that have implemented implant 
registries (3). The IRCCS Rizzoli Orthopedic Institute (IOR) was selected as a pilot center 
for the launch of the initiative, whose purpose is to accelerate the adoption and reporting of 
validated, standardised, internationally-comparable patient-reported indicators, particularly 
within patient registries. IOR was selected as a pilot center for the launch of the program in 
Italy because the Institute hosts the Registry of Orthopedic Prosthetic Implantology (RIPO) 
since 1990 (4). Given that RIPO also includes shoulder implants, the same data will be 
collected also for patients undergoing shoulder replacement. 
 
OBJECTIVES OF THE STUDY 
1) To monitor and analyze functional outcomes and quality of life reported by patients 
undergoing elective hip, knee and shoulder arthroplasty performed at the IOR;  
2) To identify predictive factors influencing the evolution of patients-reported outcome 
measures. 
 
STUDY DESIGN 
Prospective cohort study. 
 
METHODS 
Setting of the study 
The study will be carried out at 6 operative units of the IOR (Orthopedic and 
Traumatological I Clinic, Orthopedic and Traumatological Clinic II, Orthopedic and 

 
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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. 
 
Participants  
  
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 
 
Procedures 
The study consists of 3 phases: 
1.  Baseline: identification of eligible patients that the meet inclusion criteria. The 
evaluation will be performed in the pre-hospitalization ambulatory in the month 
preceding the intervention or in the ward at the time of hospitalization; in this phase 
it is planned also to: 
- present the study to the patients and collect the informed consents for study 
participation for the treatment of personal data 
- collect patients’ authorization to be contacted by mail or by telephone for the 
follow-up. 

 
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- Administer and collect 2 questionnaires (EQ-5D for all subjects and the joint-
specific questionnaire: hip, knee or shoulder). 
The baseline includes two different ways of distributing and collecting 
questionnaires, based on the method of hospitalization: 
- 
For patients in the “hospitalization-before-surgery” pathway (about 90% of 
the study population), RIPO personnel will go to the pre-admission 
ambulatory and will distribute and collect informed consents and 
questionnaires. Patient questionnaires administered to patient not eligible for 
intervention at a later stage will be destroyed.  
- 
For patients not in the “hospitalization-before-surgery” pathway (about 10% 
of the population), the RIPO personnel will go directly to the operative units, 
after checking the day before the scheduled hospitalizations, and will 
distribute and collect informed consents and questionnaires. 
The staff in charge of the distribution and collection of the questionnaires will put 
their data on the front page of the questionnaire and then they will be 
transformed into an identification code containing the initials of patients’ name 
and surname followed by a progressive number. This code be used for data 
entry in the CRF and then to reconcile the patient record with RIPO unique 
pseudo-anonymized identification code. 
 
2. 6 and 12 months follow up: the RIPO staff will send a mail containing the same 2 
questionnaires described in the baseline phase together with an accompanying 
letter with the instructions and a pre-paid envelope; the subject will be asked to 
resubmit the questionnaires. It will be also indicated how to receive direct support 
by contacting the IOR. In the event that patients - after receiving the package with 
the follow-up questionnaires - do not send them within 1 month, they will be directly 
contacted by telephone.   
 
3. Data collection and processing will be performed by the RIPO staff and the 
methodological and statistical support of the biomedical research and health 
services unit of the University of Bologna. 
 

 
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Questionnaires 
Four validated questionnaires will be used in the study. 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 (5). Three other joint-specific questionnaires 
will be administered to patients depending on the surgery procedure they will be 
undergoing. The joint-specific questionnaires are: 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. This last questionnaire will be administered in a modified version that does not 
include the assessments performed by the orthopedic surgeon (8). 
 
ENDPOINTS   
The outcomes of interest are functional outcomes and quality of life, measured through the 
total scores and the subscales of the administered questionnaires. 
In particular, for the joint-specific functional scales the total score will be used, while for the 
EQ-5D the scores of the single dimensions will be used, together with a total VAS score on 
a 0-100 scale, that measures the overall health status. 
 
The type of intervention will be used to stratify patients into three groups (hip, knee and 
shoulder). 
The socio-demographic and clinical variables of interest, such as sex, age, comorbidity, 
and patient's clinical history, will be extracted from the clinical records and the data 
recorded in the RIPO. 
 
SAMPLE SIZE 
All patients hospitalized for elective hip, knee and shoulder prosthetic surgery at the 6 
participating Operative Units will be included in the study. Based on the number of surgical 
procedures (i.e. implants) carried out in 2016, it is planned to recruit a total of 1700 

 
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patients, of which 1100 with hip replacement, 500 with knee replacement and 100 with 
shoulder replacement. A 10% rejection rate and a 40% follow-up loss are expected.  
 
QUANTITATIVE VARIABLES 
The quantitative variables of the study, which include the total scores of the scales and the 
subscales of the questionnaires, will be treated as such in the analyses and therefore not 
transformed. 
 
STATISTICAL ANALYSES 
Statistical analyses will be performed by the RIPO biostatistician in collaboration with the 
biostatistician of the methodological and statistical support unit for biomedical and on 
health services research of the Department of Biomedical and Neuromotor Sciences of the 
University of Bologna. 
To analyze the evolution of the functional outcomes and quality of life of patients at 6 and 
12 months from the surgery according to the type of intervention - and to identify predictive 
factors that influence this evolution - generalized estimation equations (GEE) and 
structural equation models (SEM) will be used. These techniques allow to obtain robust 
estimates even in the presence of missing data. We estimate an attrition rate of about 40% 
of cases, and non-compliance in resubmitting the questionnaires is hypothesized not to be 
linked to a systematic reason (for example the lower severity of patients).Therefore the 
missing data is to be considered completely random (MCAR). 
Sensitivity analyses will be performed to assess whether the hypothesized mechanism of 
data loss at follow-up is supported by the data, or if alternative mechanisms need to be 
considered. 
 
STUDY DURATION AND TIMELINE 
 
The study will have an overall duration of 30 months and will be considered in any case 
completed 6 months after the recruitment target is achieved. 
The study timeline is the following: 
• Months 1-12: Selection and enrollment of the patients and database implementation.  
• Months 6- 24: Follow up (6 and 12 months) and database implementation. 

 
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• Months 24-30: Analysis of data and dissemination of results. 
The approval of the Ethics Committee will be considered as the start date of the study. 
 
Study start date: 1/1/2019 (after approval by the Ethics Committee) 
Enrollment start date: 1/1/2019 
End date of study: 30/06/2021 
 
CONSENT TO PARTICIPATE AND PRIVACY 
Participation in the study is exclusively on a voluntary basis. Each subject will obtain 
detailed information regarding the nature and the procedures of the project and its 
purposes. All patients must sign a written consent before being included. Sensitive data 
will be processed according to the regulations in force by the study manager. Furthermore, 
participants can withdraw their consent to participate at any time, without any 
consequence. 
The protection of personal information provided by the subjects will be in accordance with 
current legislation on the protection of personal data. In line with international data 
protection legislation, the following measures will be taken: 
- 
The access to the database will be restricted to authorized persons; 
- 
The paper material will be stored in dedicated lockable cabinets not accessible to 
unauthorized parties; 
- 
The questionnaires and all paper data will also be archived in digital format at the 
medical technology laboratory with private access through a password. 
 
ETHICAL PRINCIPLES 
The study protocol and related documents will be sent before starting the study to the 
competent authorities and to the ethics committee for approval. The responsible 
investigator will ensure that the study is conducted in accordance with the Helsinki 
Declaration in its most up-to-date version (Fortaleza, October 2013), as well as with all 
national and international legislation applicable to clinical research. 
The protocol has been written and the study will be conducted according to the principles 
of ICH-GCP (ref: http://www.emea.eu.int/pdfs/human/ich/013595en.pdf). 

 
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FINAL REPORT AND PUBLICATION OF RESULTS 
The principal investigator agrees to produce a final report, to publish all the data collected 
as described in the protocol and is responsible for data integrity and to ensure that data 
are reported responsibly and consistently. The publication of data from the present study 
will take place independently of the results. 
The transmission or dissemination of study results through scientific publications and / or 
public presentations will be based on anonymous data and on statistical processing.  
 
REFERENCES 
 
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health coverage. Geneva: World Health Organization, Organisation for Economic 
Co-operation and Development, and The World Bank; 2018. Licence: CC BY-NC-
SA 3.0 IGO. 
2. OCSE 2017. Organisation for Economic Co-operation and Development (OECD). 
Patient-Reported 
Indicators 
Survey 
(PaRIS). 
Disponibile 
su: 
http://www.oecd.org/health/paris.htm 
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Mapping existing hip and knee replacement registries in Europe. Health Policy. 
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4. Stea S, Bordini B, Sudanese A, Toni A. Registration of hip prostheses at the Rizzoli 
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5. Savoia E, Fantini MP, Pandolfi PP, Dallolio L, Collina N. Assessing the construct 
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6. Torre M, Luzi I, Mirabella F, Del Manso M, Zanoli G, Tucci G, Romanini E. Cross-
cultural adaptation and validation of the Italian version of the Hip disability and 
Osteoarthritis Outcome Score (HOOS). Health Qual Life Outcomes. 2018 Jun 
4;16(1):115.  
7. Monticone M, Ferrante S, Salvaderi S, Rocca B, Totti V, Foti C, Roi GS. 
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score for patients with knee injuries: cross-cultural adaptation, dimensionality, 
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