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Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02343705
Recruitment Status : Terminated (Sponsor election)
First Posted : January 22, 2015
Last Update Posted : April 28, 2017
Sponsor:
Information provided by (Responsible Party):
Cotera, Inc.

Brief Summary:
The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.

Condition or disease Intervention/treatment Phase
Osteoarthritis Device: Latella Knee Implant System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)
Study Start Date : January 2015
Estimated Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Latella Knee Implant System Device: Latella Knee Implant System



Primary Outcome Measures :
  1. Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant [ Time Frame: 6 Months ]
  2. Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device [ Time Frame: 6 Months ]

Secondary Outcome Measures :
  1. Changes in knee outcome measures (KOOS, IKDC, NRS) [ Time Frame: 6, 12 and 24 months ]
  2. Device and procedure complication rates [ Time Frame: 6, 12 and 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of pain due to medial osteoarthritis
  • Qualifying baseline pain scores
  • Kellgren-Lawrence Grades 2-3

Exclusion Criteria:

  • Osteoporosis
  • Rheumatoid arthritis
  • Joint instability
  • Metal ion allergy
  • Permanent implant in or around the knee joint
  • Prior anterior cruciate ligament reconstruction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343705


Locations
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Netherlands
Slotervaart Hospital
Amsterdam, Netherlands
Amphia Ziekenhuis
Breda, Netherlands
St. Anna Hospital
Geldrop, Netherlands
University Hospital Maastricht
Maastricht, Netherlands
Isala
Zwolle, Netherlands
Spain
Hospital Clinic
Barcelona, Spain
Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Fundacion Jimenez Diaz
Madrid, Spain
United Kingdom
Royal London Hospital
London, United Kingdom
Norfolk & Norwich University Hospital
Norwich, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Sponsors and Collaborators
Cotera, Inc.
Investigators
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Principal Investigator: Manoj Ramachandran, MD Barts & The London NHS Trust

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Responsible Party: Cotera, Inc.
ClinicalTrials.gov Identifier: NCT02343705     History of Changes
Other Study ID Numbers: CIP-0001
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: April 28, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases