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Completed

NCT Number: NCT03719417

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

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Missouri Orthopaedic Institute

Columbia, Missouri, 65202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Unicompartmental Biologic Arthroplasty

Procedure

Unicompartmental Biologic Arthroplasty surgery.

Extensive Biologic Arthroplasty

Procedure

Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Osteoarthritis (Expansion)

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 25, 2018
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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