RECORD

• Research type

  Research Study

• Full title

  Randomized Evaluation of BST-CarGel versus Microfracture Alone On Recovery from Distal Femoral Cartilage Lesions

• IRAS ID

  219535

• Contact name

  Martyn Snow

• Contact email

  snowmartyn@gmail.com

• Sponsor organisation

  Piramal Healthcare Limited

• Clinicaltrials.gov Identifier

  NCT02981355

• Duration of Study in the UK

  4 years, 6 months, 0 days

• Research summary

  This is a randomized controlled trial to collect relevant clinical and radiological data from 158 participants undergoing one of two treatments: BST-CarGel with microfracture versus microfracture alone.
  Patient population is subjects with a single, focal cartilage lesion on the femoral condyle requiring arthroscopic operative management.
  Enrollment is estimated to take 18 months and each subject will be followed up to 24 months after treatment. Up to 15 sites will participate.
  The primary objective is to assess the impact of the BST-CarGel scaffold and microfracture versus microfracture alone for short term benefit, as measured by loaded knee pain on a visual analogue scale (VAS) (3-6 months) and long term benefit, as measured by the loaded knee pain (9, 12, and 24 months), the Tegner Activity Score (TAS), International Knee Documentation Committee (IKDC), and Knee Injury and Osteoarthritis Outcome Score (KOOS) at 3, 6, 9, 12 and 24 months post-operatively.

  Data that will be collected at baseline/surgery include demographics/medical history, pain VAS, TAS, IKDC, KOOS,
  AE and safety outcomes, EQ-5D-3L, and resource utilization.

  Data that will be collected about the clinical follow-up include loaded pain VAS, TAS, IKDC, KOOS, MOCART II (T2 MRI), AE and safety outcomes, EQ-5D-3L, and resource utilization.

  Total study duration for study participants will be 24 months with follow-up visits planned at 2 and 6 weeks, 3, 6, 9,
  12, and 24 months post-operatively.

  Two interim analyses describing the clinical outcomes are planned. The first one will adjust for primary and
  secondary outcomes and will occur after approximately 50 participants have been enrolled. The second interim
  analysis will occur after 90 participants are enrolled in order to adjust for sample size.

• REC name

  West Midlands - Black Country Research Ethics Committee

• REC reference

  17/WM/0169

• Date of REC Opinion

  6 Jun 2017

• REC opinion

  Further Information Favourable Opinion