A Randomized Controlled Trial Comparing Chondro-Gide® to Microfracture Alone for Treatment of Knee Cartilage Defects.

Cartilage Injury Clinical Trial

Official title:

Randomised Multi-Center Study: Microfracturing With Chondro-Gide® for the Treatment of Isolated Cartilage Defects in the Knee Project-Nr.: 10830-003

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993510
• Other study ID #: 10830-003
• Status: Completed
• Phase: Phase 3
• First received: December 2, 2016
• Last updated: February 20, 2017
• Start date: December 2003
• Est. completion date: July 2016

Study information

• Verified date: February 2017
• Source: Geistlich Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cartilage Injury
• Osteochondritis
• Osteochondritis Dissecans

Intervention

Procedure:
• Microfracture
Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot

Device:
• Chondro-Gide sutured
Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
• Chondro-Gide glued
Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy

Locations

Country	Name	City	State
Germany	University of Regensburg	Bad Abbach
Germany	Universitätsklinikum Freiburg	Freiburg
Germany	Universitätsklinikum Giessen	Giessen
Germany	Orthopedikum Hamburg	Hamburg
Germany	Unfallklinik Hannover	Hanover
Germany	University of Schleswig-Holstein	Lubeck
Germany	Sportklinik Ravensburg	Ravensburg

Sponsors (1)

Lead Sponsor	Collaborator
Geistlich Pharma AG

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Anders S, Volz M, Frick H, Gellissen J. A Randomized, Controlled Trial Comparing Autologous Matrix-Induced Chondrogenesis (AMIC®) to Microfracture: Analysis of 1- and 2-Year Follow-Up Data of 2 Centers. Open Orthop J. 2013 May 3;7:133-43. doi: 10.2174/187 — View 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 Jan 20. doi: 10.1007/s00264-016-3391-0. [Epub — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years	The macroscopically assessed integration, surface properties and extent of filling of the defect and the microscopically assessed using the International Cartilage Repair Society (ICRS) score	2 years post-surgery
Primary	MRI (magnetic resonance imaging) assessment of structural repair parameters.	Structural repair is assessed with magnetic resonance imaging (MRI, 1.5T) by an independent and blinded radiologist, with a focus on the extent, signal intensity and surface of the defect filling, integration to adjacent cartilage, and bone marrow lesion (BML).	6 months and 1,2 and 5 years post-surgery
Secondary	Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.	The Change from Baseline will be evaluated.	6 months and 1,2 and 5 years post-surgery
Secondary	Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).	The Change from Baseline will be evaluated.	6 months and 1,2 and 5 years post-surgery
Secondary	Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".	The Change from Baseline will be evaluated.	6 months and 1,2 and 5 years post-surgery
Secondary	Adverse Events (AE) Review	The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.	5 years post-surgery