Knee joint replacement follow up study in patients with knee osteoarthritis which participated to the CL3-12911-018 study.

Conditions: OsteoarthritisThe medical condition investigated in the CL3-12911-018 study was osteoarthritis. The applied CL3-12911-040 trial, CL3-12911-018 follow-up study, is thus performed in osteoarthritic patients.
MedDRA version: 14.1Level: PTClassification code 10031161Term: OsteoarthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2011-004046-18-ES

Lead Sponsor: aboratorios Servier

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1206

Inclusion Criteria

Patients included in the CL3-12911-018 study and having received the CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo) for at least one year (at least 365 days of treatment during the CL3-12911-018 study).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 772
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 434

Exclusion Criteria

Unlikely to cooperate in the study (such as patients suffering from dementia).
Patients unable to provide the information requested by the study.
Refusal to provide the study?s informed consent.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To collect data on knee joint replacement procedures or procedures practiced in the knee (arthroscopy, osteotomy or other) over 5 years in patients with knee osteoarthritis having participated in the CL3-12911-018 study and having received at least one year (365 days) of CL3-12911-018 study treatment (Strontium Ranelate 1g/2g or placebo).;Secondary Objective: NA;Primary end point(s): - Knee joint replacement in the target knee (knee followed in the CL3-12911-018 study).<br>- Knee surgery or other procedure (arthroscopy, osteotomy or other).;Timepoint(s) of evaluation of this end point: Each 12 months.

Secondary Outcome Measures