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

Knee joint replacement over 5 years in patients with knee osteoarthritis. A long term follow up study in patients of the CL3-12911-018 study.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-004046-18-CZ

Enrollment

1206

Registered

2012-01-19

Start date

2012-02-23

Completion date

Unknown

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis The 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: 14.1 Level: PT Classification code 10031161 Term: Osteoarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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: ;Primary end point(s): - Knee joint replacement in the target knee (knee followed in the CL3-12911-018 study). - Knee surgery or other procedure (arthroscopy, osteotomy or other). ;Timepoint(s) of evaluation of this end point: Each 12 months.	—

Measure

Time frame

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: ;Primary end point(s): - Knee joint replacement in the target knee (knee followed in the CL3-12911-018 study). - Knee surgery or other procedure (arthroscopy, osteotomy or other). ;Timepoint(s) of evaluation of this end point: Each 12 months.

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Countries

Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Germany, Italy, Lithuania, Poland, Portugal, Russian Federation, Spain

Contacts

Public ContactClinical Studies Department

Institut de Recherches Internationales Servier

clinicaltrials@servier.com00330155724366

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026