Ortho Research

Clinical Trials

NOVOCART 3D

Study Contact:

Kaitlyn Shank 434-243-5653

IRB-HSR 17371

Clinic Visit Registration: 17371-Diduch

Inclusion Criteria

  • Age 18-65 years
  • Isolated articular cartilage defect (ICRS grade 3-4) of the femoral condyle (medial, lateral, or trochlea) with a total area of 2.0 – 6.0 cm2 (pre-debridement) and treatable with one implant
  • Inadequate response to conservative treatment (analgesics, rest, physical therapy)
  • Full knee range of motion (relative to contralateral)
  • ≤ 18/36 (50 out of 100) on KOOS-pain subdomain
  • ≤ 25/68 (63 out of 100) on KOOS-ADL subdomain

Exclusion Criteria

  • Instability of the knee compared to contralateral
  • Loss of knee extension > 5° or flexion > 15°
  • Uncorrected ligament reconstruction, realignment
  • Multiple cartilage lesions requiring more than one prepared defect
  • DJD assessed by X-ray within 3 months of screening
  • Clinically significant arthritis, rheumatological disease, bone disease, lower extremity pain not due to articular cartilage defect, or low back pain
  • Diffuse chondromalacia
  • Surgery on contralateral knee within 6 months prior to the scheduled arthroscopy
  • Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation, and/or microfracture (prior debridement/ lavage > 3 months are acceptable)
  • IA injections within 1 month of surgery
  • Meniscus deficiency that will not be repaired at time of surgery
  • BMI > 40
  • Receiving workman’s compensation for knee injury

*Surgical treatments including alignment procedures, meniscal repair or meniscectomy, and ACL reconstruction, may be allowed if performed at time of surgery

Study Summary

  • Screening ≤ 42 days of surgery: Clinic visit (register to grant), Research MRI*
  • Baseline ≤ 2 days of surgery 1: Clinic visit + X-rays (register to grant)*
  • Surgery: Pre-authorize to insurance, Graft is covered by Company [MUST NOTIFY COMPANY]
    • Surgery 1: Microfracture or explant removal
    • Surgery 2: (within 21-28 days of Surgery 1) NOVOCART implantation (if applicable)
  • Discharge: OPSC
  • 2 weeks ± 3 days: Clinic visit (register to grant)
  • 3 months ± 15 days: Clinic visit + X-rays (register to grant), Research MRI
  • 6 months ± 15 days: Clinic visit + X-rays (register to grant)
  • 12 months ± 15 days: Clinic visit + X-rays (register to grant), Research MRI
  • 18 months ± 15 days: Clinic visit + X-rays (register to grant)
  • 2 years ± 15 days: Clinic visit + X-rays (register to grant), Research MRI
  • 2.5 years ± 30 days: Clinic visit (register to grant)
  • 3 years ± 30 days: Clinic visit (register to grant)
  • 3.5 years ± 30 days: Clinic visit (register to grant)
  • 4 years ± 30 days: Clinic visit (register to grant)
  • 4.5 years ± 30 days: Clinic visit (register to grant)
  • 5 years ± 30 days: Clinic visit (register to grant), Research MRI

*Screening and baseline may be completed during the same visit

Baseline visit:

  • X-ray within 3 months to verify joint disease status if necessary

Payment:

  • $50/follow up visit (8 total)

  • Complete vendor registration through UVA Procurement at: https://www.procurement.virginia.edu/pagevendorregistrationform

  • Contact Sarah Spangler (cc to Kaitlyn Shank) with patient name, MRN, DOS, study visit

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