Clinical trial NCT03257371: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
Official title: A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-traumatic Osteoarthritis
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2017-08-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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

Primary outcomes:
measure: Visual Analogue Scale Pain Score
timeFrame: 12 months
Secondary outcomes:
measure: Tegner Activity Level Scale
timeFrame: 12 months
measure: International Knee Documentation Committee (IKDC) Total Score
timeFrame: 12 months
measure: PROMIS - Physical Function and Mobility
timeFrame: 12 months
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Missouri Orthopaedic Institute
state: Missouri
Study officials:
affiliation: University of Missouri, Department of Orthopaedic Surgery
name: James Stannard, MD
role: PRINCIPAL_INVESTIGATOR
References: