Norwegian Cartilage Project - Microfracture
Condition: Knee Injury; Cartilage Injury
MeSH terms: Wounds and Injuries; Knee Injuries; Fractures, Stress
Study type: Interventional

Summary: 
      114 patients between 18 and 50 years with an isolated focal cartilage defect in the knee will
      be randomized to either receive arthroscopic microfracture or arthroscopic debridement. Both
      groups will then undergo a systematic physiotherapy training regime for 6-9 months. The
      groups will then be compared for results, after 3, 6, 12 and 24 months, by using validated
      patient reported outcome scores (Lysholm, KOOS, Tegner) and EQ5D as well as clinical
      examination and radiological findings at 2 years (MRI).
    

Detailed description: 
      Focal cartilage defects in the knee - A randomized controlled trial comparing arthroscopic
      microfracture with arthroscopic debridement.

      Clinical compare the effect of arthroscopic microfracture (MF) with arthroscopic debridement
      (AD) in patients with symptomatic full thickness knee cartilage injuries less than 2cm2.

      Focal cartilage injuries in the knee might have devastating effect both in the short term and
      in the long term. Various surgical treatment options are available, with microfracture the
      most used technique globally. Meta-analysis and systematic reviews have required
      well-designed, long-term, multicenter studies to evaluate clinical outcomes of microfracture
      with the use of a "no treatment" group as a control group.

      H0: There is no difference in KOOS QoL after AM or AD 24 months after surgery. H1: There is a
      difference in KOOS QoL after AM or AD 24 months after surgery.

      Questionnaires: KOOS, Tegner score, Lysholm score, EQ-5D, VAS. Physical examination: range of
      motion and hop test. Radiology: x-ray and MRI of the knee.

      Primary aim: KOOS quality of life (QoL) subscore.

      Prospective, double-blinded parallel-group multicenter study with 2 treatment arms. Approx.
      24 months inclusion and 24 months follow up. In total 4 years.

      All will be invited to participate in late controls after 5 and 10 years.

      6 Norwegian hospitals: Akershus University Hospital, Oslo University Hospital - Ullevaal,
      Kristiansund Hospital, Aalesund Hospital, Diakonhjemmet Hospital and Haukeland University
      Hospital.

      114 patients Inclusion: age 18-50 years old, single symptomatic cartilage defect on femoral
      condyle or trochlea.

      2 treatment groups with 57 patients in each group. Follow up after 3 months (± 2 weeks), 6
      months (± 4 weeks), 12 months (± 6 weeks) and 24 months (± 8 weeks). All will be invited to
      participate in late controls after 5 and 10 years. If any unforeseen complication outside
      normal clinical practice occurs, the sponsor representative will be contacted as soon as
      possible with a parallel message to the local coordinators at the involved hospitals. During
      each follow up, there will be a case report form (CRF) regarding complications and safety.

      A 5 mL venous blood sample will be drawn on the day of operation. The blood sample will be
      centrifuged before serum is pipetted in a sterile tube. The serum will be analyzed at Oslo
      University Hospital - Rikshospitalet on the cartilage biomarker microRNA-140 (miR-140).

      If normal distribution, aims will be analyzed using linear mixed models (LMM), and the
      primary aim will be performed as a post hoc test for the LMM, similar to performing a
      two-sample t-test. If no normal distribution, analysis will be performed using Mann-Whitney
      U-test.

      Detecting a difference of 10 with 80 percent Power, uing a standard deviation of 18, this
      yields 52 patients in each group. By adding 10% due to loss during follow-up, we therefore
      plan to include a total of 114 patients.

      No interim analysis will be done. Monitor from Health Møre and Romsdal HF. The end of this
      study is 24 months after the last included patient.
    

Intervention name(s): Arthroscopic microfracture (MF); Arthroscopic debridement (AD)
Intervention type(s): Procedure; Procedure
Intervention description(s): Arthroscopy With microfracture procedure; Arthroscopy With debridement procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Articular cartilage; Focal cartilage injury; Focal cartilage injury in the knee; Knee cartilage; Microfracture; Debridement