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Trial record 62 of 75 for:    "Collagen Disease" | "Triamcinolone"

Single Blinded First CMC Osteoarthritis Treatment

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ClinicalTrials.gov Identifier: NCT03196310
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Kettering Health Network

Brief Summary:
Single blinded PRP vs. Corticosteroid vs. Placebo (normal saline) intra-articular injection for basal joint arthritis.

Condition or disease Intervention/treatment Phase
Osteoarthritis Thumb Drug: Platelet Concentrate Drug: Corticosteroid injection Other: Normal Saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Patients will be blinded to therapy they receive
Primary Purpose: Treatment
Official Title: Randomized Single Blinded First CMC Osteoarthritis Treatment: Therapy and Bracing Alone vs. Intra-Articular Corticosteroid Injection vs Intra-Articular Leukocyte Depleted Platelet Rich Plasma
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PRP
Intra-articular injection of platelet rich plasma.
Drug: Platelet Concentrate
Platelet Rich plasma

Active Comparator: Corticosteroid
Intra-articular injection of kenalog.
Drug: Corticosteroid injection
Kenalog

Placebo Comparator: Normal Saline
Intra-articular injection of normal saline
Other: Normal Saline
Placebo




Primary Outcome Measures :
  1. Disabilities arm shoulder and hand score [ Time Frame: 1 year ]
    functional score


Secondary Outcome Measures :
  1. Pinch Strength [ Time Frame: 1 year ]
    Objective measurement


Other Outcome Measures:
  1. Visual Analog Score [ Time Frame: 1 year ]
    Pain reduction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage 1-3 osteoarthritis of the basal joint

Exclusion Criteria:

  • Patients with Stage 4 1st carpometacarpal joint arthritis as described by Eaton
  • Patients who have received a corticosteroid injection in the last year to the 1st CMC joint on the proposed study side
  • Patients who have scaphotriquetral, radioscaphoid, or scaphotrapezial osteoarthritis
  • Patients who have concurrent DeQuervain's tenosynovitis or intersection syndrome or have been treated for either of these in the last 3 months
  • Patients undergoing evaluation of cervical radiculopathy
  • Patients with fibromyalgia or inflammatory rheumatic disease
  • Patients with Pressier disease, Kienbock's, or avascular necrosis of the scaphoid
  • Patients with any history of primary or secondary bone tumor
  • Patients that are pregnant or terminally ill

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): NCT03196310


Contacts
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Contact: James N Jackson, DO 9044779617 jnjackson.med@gmail.com

Locations
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United States, Ohio
Orthopedic Associates of Southwest Ohio Recruiting
Centerville, Ohio, United States, 45459
Contact: Laura Peterson    800-824-9861    lpeterson@oaswo.com   
Sponsors and Collaborators
Kettering Health Network

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Responsible Party: Kettering Health Network
ClinicalTrials.gov Identifier: NCT03196310     History of Changes
Other Study ID Numbers: 17-008
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

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