Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Biologic Joint Replacement Strategy for Knee Trauma and Post-Traumatic Osteoarthritis

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719417
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : May 6, 2019
Sponsor:
Information provided by (Responsible Party):
James Stannard, University of Missouri-Columbia

Brief Summary:
Participants will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Post-traumatic Osteoarthritis Procedure: Unicompartmental Biologic Arthroplasty Procedure: Extensive Biologic Arthroplasty Not Applicable

Detailed Description:
With IRB approval, patients will be enrolled in a prospective clinical trial to assess outcomes in 2 cohorts of patients undergoing unicompartmental versus more extensive biologic OCA transplantation of the knee using MOPSTM-preserved allografts (including menisci), anatomically-shaped allografts, autogenous bone marrow aspirate concentrate (BMC)-treated donor bone, and treatment-specific postoperative rehabilitation. Demographic and operative data will be collected. Outcome assessments will include VAS pain, IKDC, SANE, Tegner and PROMIS Mobility for knee at 6 months and yearly after surgery. In addition, serial limb alignment measurements, ultrasonographic assessments of meniscal location and integrity, quantitative MRIs for cartilage composition, and serum and urine biomarkers for treatment monitoring will be performed. All complications and re-operations will be recorded. OCA survival will be determined based on maintenance of acceptable levels of pain and function and/or need for revision surgery or total knee arthroplasty.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Unicompartmental Biologic Arthroplasty
Subject will be receiving a unicompartmental biologic arthroplasty only
Procedure: Unicompartmental Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery.

Active Comparator: Extensive Biologic Arthroplasty
Subject will be receiving a unicompartmental biologic arthroplasty with at least one additional surface in another compartment being replaced concurrently.
Procedure: Extensive Biologic Arthroplasty
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently




Primary Outcome Measures :
  1. VAS Pain Score (Visual Analog Scale) [ Time Frame: 12 Months ]
    This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain


Secondary Outcome Measures :
  1. International Knee Documentation Committee Score (IKDC) [ Time Frame: 12 Months ]
    This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function score.

  2. Single Assessment Numeric Evaluation (SANE) score [ Time Frame: 12 Months ]
    This score looks at what the patient rates their knee with 100% being normal, and 0% being as far from normal as possible

  3. PROMIS Mobility [ Time Frame: 12 Months ]
    This looks at mobility and function on a scale of 14.1 to 61.7 with higher scores equaling higher mobility



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint (unicompartmental) or unicompartmental and other femoral condyle, tibial plateau, trochlea and/or patella.
  • Between the age of 18-55

Exclusion Criteria:

  • Acute injury to any other part of the affected lower extremity
  • Inability to comply with protocol
  • BMI greater than 40
  • The subject is either pregnant or a prisoner
  • Currently involved in worker's compensation case at the time of enrollment

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): NCT03719417


Contacts
Layout table for location contacts
Contact: Kylee Rucinski 573-884-6216 rucinskik@health.missouri.edu
Contact: Stacee Clawson 5738843077 clawsons@health.missouri.edu

Locations
Layout table for location information
United States, Missouri
Missouri Orthopaedic Institute Recruiting
Columbia, Missouri, United States, 65202
Contact: Kylee Rucinski    573-884-6216    rucinskik@health.missouri.edu   
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Layout table for investigator information
Principal Investigator: James Stannard, MD University of Missouri, Department of Orthopaedic Surgery

Layout table for additonal information
Responsible Party: James Stannard, Professor, Orthopedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03719417    
Other Study ID Numbers: 2011153
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by James Stannard, University of Missouri-Columbia:
Knee Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases