Missouri Orthopaedic Institute
Columbia, Missouri, 65202, United States
NCT Number: NCT03719417
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.
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Notify Me18 year–55 year
All sexes
Interventional
Not applicable
Columbia, Missouri, 65202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Unicompartmental Biologic Arthroplasty surgery.
Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
Time frame: 12 Months
This pain score is between 0 and 10, with 0 being no pain and 10 being the worst pain
Time frame: 12 Months
This score looks at pain and function scores. 0 is the lowest score and 100 is the highest function 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
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
University of Missouri-Columbia
Other
A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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