NCT03208062

Brief Summary

Musculoskeletal disorders are an heterogeneous group of diseases that represent one of the major causes of disability. Considering the importance of studying these pathologies, it is necessary to develop research lines based on the availability of human biological material from highly clinically relevant patients. The purpose of this project is therefore the establishment of a bank of biological material (biobank) to investigate important aspects related to the pathologies of the musculoskeletal system through subsequent bio-molecular characterization studies.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
13mo left

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
May 2017May 2027

Study Start

First participant enrolled

May 31, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 5, 2017

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2027

Last Updated

February 17, 2025

Status Verified

February 1, 2025

Enrollment Period

10 years

First QC Date

June 30, 2017

Last Update Submit

February 13, 2025

Conditions

Tissue Banking

Keywords

BiobankWaste materialOrthopaedic

Outcome Measures

Primary Outcomes (1)

  • BioBanking of waste biological materials

    The aim of the project is to create a biobanch of waste material from patients undergoing prosthetic surgery and hospital rehabilitation and oncologic orthopedic surgery to be used in specific studies aimed at defining the pathophysiological bases and / or new possible criteria Diagnostic / prognosis of locomotor system pathologies and, specifically, osteoarthritis of the hip and knee, primary and secondary bone tumors, infection of hip and knee prostheses requiring plant revision.

    5 years

Study Arms (1)

Patients

The target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures and collection of waste materials: * patients with osteoarthritis of the hip or knee and rehabilitated in the institute * patients with primary and secondary tumors of the skeleton * patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects(\>18 years included). Patients will be considered eligible for enrollment in the project if they can provide informed written consent.

Other: collection of waste materials

Interventions

collection of waste materialsOTHER

osteoarthritis of the hip or knee and rehabilitated in the institute; primary and secondary tumors of the skeleton; prosthetic examination as a result of plant infection

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The target group corresponds to the patients admitted to our Institute who are candidates for the following surgical or biopsy procedures: * patients with osteoarthritis of the hip or knee and rehabilitated in the institute * patients with primary and secondary tumors of the skeleton * patients undergoing prosthetic examination as a result of plant infection The population will include adult subjects. Patients will be considered eligible for enrollment in the project if they can provide informed written consent.

You may qualify if:

  • Patients admitted to our Institute
  • Patients aged ≥18 years
  • Patients with osteoarthritis of hip or knee and rehabilitated in the institute
  • Patients with primary and secondary tumors of the skeleton
  • Patients undergoing prosthetic surgery following infection of the implant

You may not qualify if:

  • Participants aged \<18 years
  • Participants unable to release the Informed Consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Ospedale Galeazzi-Sant'Ambrogio (coordinator)

Milan, 20157, Italy

RECRUITING

Istituto Clinico San Siro (satellite center)

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, bone, muscles, cartilage, tumor.

Study Officials

  • Giuseppe Banfi

    IRCCS Istituto Ortopedico Galeazzi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Cittera

CONTACT

00390283502224elena.cittera@grupposandonato.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 5, 2017

Study Start

May 31, 2017

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Last Updated

February 17, 2025

Record last verified: 2025-02

Locations

IT(2)