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A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03257371
Recruitment Status : Completed
First Posted : August 22, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
James Stannard, University of Missouri-Columbia

Brief Summary:

With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal pathology in the medial or lateral femorotibial joint as determined by physical examination, diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV changes in any other compartment of the knee, acute injury to any other part of the affected lower extremity, or inability to comply with the protocol.

After enrollment, patients will undergo standardized knee radiography, and complete assessments (described below). Size-matched (standard clinical methodology) proximal tibia with meniscus and distal femur allografts from the same donor will be obtained from a tissue bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS technology. The medial or lateral femoral condyle will be replaced using our novel instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed and used to replace the entire medial or lateral tibial condyle while sparing the attachments of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated using commercial available implants used for bone fixation. In the event that the meniscus has been detached from the tibial plateau during graft harvest, the periphery of the meniscus will be sutured to the capsule following standard meniscus transplant procedure.

Patients will undergo controlled post-operative rehabilitation according to standard protocols for osteochondral with concurrent meniscus allografts.

Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis.


Condition or disease
Post-traumatic Osteoarthritis

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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
Actual Study Start Date : December 30, 2016
Actual Primary Completion Date : July 2019
Actual Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Group/Cohort
Post-traumatic knee OA
post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty



Primary Outcome Measures :
  1. VAS Pain Score [ Time Frame: 12 months ]
    Pain assessment


Secondary Outcome Measures :
  1. SF-12 [ Time Frame: 12 months ]
    survey to assess mental and physical functioning and overall health

  2. Tegner Activity Level Scale [ Time Frame: 12 months ]
    Patient reported outcome scale related to work and sporting activities

  3. International Knee Documentation Committee (IKDC) subjective and objective scores [ Time Frame: 12 months ]
    Knee specific patient reported outcome

  4. PROMIS - Physical Function and Mobility [ Time Frame: 12 months ]
    A survey related to physical function and mobility

  5. PROMIS - Global Health Scale [ Time Frame: 12 months ]
    A survey related to multiple areas of health

  6. PROMIS - Pain Interference [ Time Frame: 12 months ]
    A patient's self-reported consequences of pain

  7. PROMIS - Physical Function [ Time Frame: 12 months ]
    questionnaire related to standing and moving

  8. Marx score [ Time Frame: 12 months ]
    Activity rating scale



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.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Criteria

Inclusion Criteria:

  1. Patient requiring repair via tibial plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
  2. The subject is able and willing to consent to participate in the study

Exclusion Criteria:

  1. Acute injury to any other part of the affected lower extremity
  2. The subject is unwilling, or unable to consent due to psychiatric condition or legal incompetence
  3. BMI > 40
  4. Age > 50 at the time of enrollment
  5. The subject is either pregnant, or a prisoner
  6. Currently involved in a workers' 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): NCT03257371


Locations
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United States, Missouri
Missouri Orthopaedic Institute
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
James Stannard
Investigators
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Principal Investigator: James Stannard, MD University of Missouri, Department of Orthopaedic Surgery
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Responsible Party: James Stannard, Chairman, Department of Orthopaedic Sugery; Medical Director, Missouri Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT03257371    
Other Study ID Numbers: 2002751
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases