Clinical trial NCT02993510: A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.
Official title: Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cartilage Injury
Osteochondritis Dissecans
Keywords: microfracture
enhanced marrow stimulation
articular cartilage
Autologous Matrix-Induced Chondrogenesis
Chondro-Gide®
knee surgery
AMIC
Lead sponsor: Geistlich Pharma AG
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of using Chondro-Gide® collagen membrane either sutured or glued compared to microfracture alone in the treatment of symptomatic cartilage defects of the knee.

Detailed description: * Prospective, randomized, active treatment-controlled, open-label multicenter study (up to 40 sites in the US and EU).
* All subjects that meet preoperative screening eligibility criteria will be randomized to treatment with Chondro-Gide® either sutured or glued or Microfracture alone.
* Eligible and consenting subjects are randomized in a 1:1:1 ratio using centralized randomization list to receive one of the following treatments: Group I: Microfracture alone; Group II: Microfracture covered with a Chondro-Gide® membrane glued with fibrin glue (AMIC glued); Group III: Microfracture covered with a Chondro-Gide® membrane sutured (AMIC sutured)
* All subjects will be assessed at intervals post-procedure (6 weeks, 3 months, and 1,2 and 5 years).
* Subjects will be required to follow a strict pre-specified post-surgery rehabilitation protocol specific to the defect location.
* Measures to assess effectiveness and safety will be conducted at all follow-ups.
* Safety will be assessed by the collection of adverse events at all timepoints.

Eligibility criteria: Inclusion Criteria:

* Male or female between 18 and 50
* One or two cartilage defects Grade III or IV according to Outerbridge classification
* Defect size between 2 and 10 cm2 (inclusive)
* Intact normal surrounding cartilage to suture the Chondro-Gide® membrane
* Informed consent
* Patient willing to fulfill a strict postoperative physiotherapy scheme

Exclusion Criteria:

* More than 2 defects
* Defects on both knees
* X-ray signs of osteoarthritis
* Bone lesion \> 0.7 cm in the defect
* Knee instability, varus or valgus deformation, status after complete meniscus resection, status after mosaicplasty, patella dysplasia
* Rheumatoid, infectious disease
* Skin lesion on the operated knee
* Treatment with cartilage building medication
* Drug and alcohol abuse
* Chronic heart disease, endocrine or metabolic disease, Haemophilia A/B
* Pregnancy or lactation
* Collagen allergy
* Participation in other Trials

Primary outcomes:
measure: Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years
timeFrame: 2 years post-surgery
measure: MRI (magnetic resonance imaging) assessment of structural repair parameters.
timeFrame: 6 months and 1,2 and 5 years post-surgery
Secondary outcomes:
measure: Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.
timeFrame: 6 months and 1,2 and 5 years post-surgery
measure: Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).
timeFrame: 6 months and 1,2 and 5 years post-surgery
measure: Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".
timeFrame: 6 months and 1,2 and 5 years post-surgery
measure: Adverse Events (AE) Review
timeFrame: 5 years post-surgery
Other outcomes:
Locations:
city: Bad Abbach
country: Germany
facility: University of Regensburg
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Giessen
country: Germany
facility: Universitätsklinikum Giessen
city: Hamburg
country: Germany
facility: Orthopedikum Hamburg
city: Hanover
country: Germany
facility: Unfallklinik Hannover
city: Lubeck
country: Germany
facility: University of Schleswig-Holstein
city: Ravensburg
country: Germany
facility: Sportklinik Ravensburg
Study officials:
affiliation: University of Regensburg
name: Sven Anders, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC(R)) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7:133-43. doi: 10.2174/1874325001307010133. Print 2013.
citation: Volz M, Schaumburger J, Frick H, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of Autologous Matrix-Induced Chondrogenesis over microfracture at five years. Int Orthop. 2017 Apr;41(4):797-804. doi: 10.1007/s00264-016-3391-0. Epub 2017 Jan 20.