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Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee (LongTermOC)

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ClinicalTrials.gov Identifier: NCT02308358
Recruitment Status : Withdrawn (New study initiated to replace this one)
First Posted : December 4, 2014
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
James Stannard, University of Missouri-Columbia

Brief Summary:
The purpose of this study is to evaluate the functional and clinical outcomes of patients receiving femoral condyle osteochondral allografts, to evaluate potential predisposing factors to failure of such grafts, and to compare the overall outcomes of the grafts to the current standard of care for smaller lesions, microfracture. Our hypothesis is that patients treated with these allografts will demonstrate significant functional improvement as measured by validated outcome scoring measures and their function will be at least equal to that of microfracture outcomes.

Condition or disease
Outcomes of Allograft

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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long Term Outcomes of Osteochondral Allografts for Osteochondral Defects of the Knee.
Study Start Date : May 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Group/Cohort
Allograft Transplantation
Subjects with femoral condyle osteochondral defects ≥10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for allograft transplantation.
Microfracture Treatment
Subjects with femoral condyle osteochondral defects <10mm, as determined by MRI or diagnostic knee arthroscopy, will be recruited for microfracture treatment.



Primary Outcome Measures :
  1. Pain Level [ Time Frame: 1 Year ]
    Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.

  2. Activity Level [ Time Frame: 1 Year ]
    Subject outcomes will be assessed through validated outcomes scoring systems, including the International Knee Documentation Committee (IKDC), the SF-36 health survey and the Tegner activity scale. These will be completed by the participants prior to the index procedure and at the 3, 6 and 12 month visits and yearly thereafter.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients of orthopaedic surgeons in Columbia, Missouri at the University of Missouri-Columbia Hospital and Clinics.
Criteria

Inclusion Criteria:

  1. Adults age ≥18 years
  2. Femoral condyle osteochondral defect ≥10mm as determined by MRI or diagnostic knee arthroscopy for allograft transplantation, defect <10mm for microfracture treatment
  3. Must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations.
  4. Must be able and willing to follow a standardized rehabilitation protocol.
  5. Must be able to read and understand English or a language for which translated versions of the patient reported questionnaires and Informed consent form are available.
  6. Must be able to sign informed consent and must voluntarily sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved subject Informed Consent Form.

Exclusion Criteria:

  • 1. Presence of ipsilateral articular fractures, knee ligament injuries or extensor mechanism injuries

    2. Presence of severe soft tissue injuries around the knee that have required or may require skin grafting or flap coverage.

    3. Presence of a previous below knee amputation

    4. Presence of inflammatory systemic arthritis or disease involving the index joint (i.e. gout)

    5. Is a prisoner

    6. Is receiving workman's compensation

    8. Subject is mentally incompetent such that would preclude the subject from providing adequate consent and/or complying with study requirements

    9. Based on a clinical history, physical examination and/or subject presentation, subject has, or is suspected to have, a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements


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): NCT02308358


Locations
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United States, Missouri
University of Missouri-Hospital and Clinics
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: James P Stannard, MD Missouri Orthopaedic Institute
Study Director: James L Cook, DVM Missouri Orthopaedic Institute
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Responsible Party: James Stannard, Professor and Chairman - Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02308358    
Other Study ID Numbers: 1210204
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Stannard, University of Missouri-Columbia:
Osteochondral Defect
Femoral condyle osteochondral defect
Additional relevant MeSH terms:
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Osteochondrosis
Bone Diseases
Musculoskeletal Diseases