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Hydrolyzed Collagen Formulation vs Placebo in Knee Osteoarthritis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2027v10
  2. Re-verified, no change to tracked fieldsv9
  3. Primary completion date: Aug 1, 2022 to Dec 2025v8
  4. Study completion date: Jul 2023 to Dec 2025v7
  5. Primary completion date changed from estimate of Aug 2022 to Aug 1, 2022v6
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  1. Primary completion date: Mar 2022 to Aug 2022v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 2021 to Feb 16, 2022
    v4
  3. Start date: Sep 2021 to Dec 2021v3
  4. Secondary endpoints: details revised at 3 of 13 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single intra-articular collagen injection versus a single placebo (saline solution) infiltration in the infiltrative treatment of knee osteoarthritis. The evaluation will be performed through clinical, subjective and objective assessments.
Trial Details
NCT Number NCT04998188
Lead Sponsor Istituto Ortopedico Rizzoli
Conditions
(from sponsor)		 Knee Osteoarthritis
Related terms Osteoarthritis, Osteoarthritis, Knee
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov