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

Primary Purpose

Cartilage Injury, Osteochondritis Dissecans

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Microfracture

Chondro-Gide sutured

Chondro-Gide glued

About this trial

This is an interventional treatment trial for Cartilage Injury focused on measuring microfracture, enhanced marrow stimulation, articular cartilage, Autologous Matrix-Induced Chondrogenesis, Chondro-Gide®, knee surgery, AMIC

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Regensburg
Universitätsklinikum Freiburg
Universitätsklinikum Giessen
Orthopedikum Hamburg
Unfallklinik Hannover
University of Schleswig-Holstein
Sportklinik Ravensburg

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

microfracture

Microfracture with Chondro-Gide sutured

Microfracture with Chondro-Gide glued

Arm Description

Microfracture is an arthroscopic surgical technique involving placement of microfracture penetrations within the cartilage defect to provide stem cells and growth factors from the bone marrow to aid cartilage repair

Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure

Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure

Outcomes

Primary Outcome Measures

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

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).

Secondary Outcome Measures

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.

Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).

The Change from Baseline will be evaluated.

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.

Adverse Events (AE) Review

The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.

Full Information

NCT ID

NCT02993510

First Posted

December 2, 2016

Last Updated

February 20, 2017

Sponsor

Geistlich Pharma AG

1. Study Identification

Unique Protocol Identification Number

NCT02993510

Brief Title

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

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 2003 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Geistlich Pharma AG

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cartilage Injury, Osteochondritis Dissecans

Keywords

microfracture, enhanced marrow stimulation, articular cartilage, Autologous Matrix-Induced Chondrogenesis, Chondro-Gide®, knee surgery, AMIC

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

microfracture

Arm Type

Active Comparator

Arm Description

Arm Title

Microfracture with Chondro-Gide sutured

Arm Type

Experimental

Arm Description

Microfracture covered with a collagen membrane (Chondro-Gide®) using atraumatic sutures in a one-step mini-arthrotomy procedure

Arm Title

Microfracture with Chondro-Gide glued

Arm Type

Experimental

Arm Description

Microfracture covered with a collagen membrane (Chondro-Gide®) using fibrin glue in a one-step mini-arthrotomy procedure

Intervention Type

Procedure

Intervention Name(s)

Microfracture

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Chondro-Gide sutured

Intervention Description

Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy

Intervention Type

Device

Intervention Name(s)

Chondro-Gide glued

Intervention Description

Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy

Primary Outcome Measure Information:

Title

Histological evaluation of structural repair of evaluable biopsies harvested from the core of the index lesion during arthroscopy at 2 years

Description

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

Time Frame

2 years post-surgery

Title

MRI (magnetic resonance imaging) assessment of structural repair parameters.

Description

Time Frame

6 months and 1,2 and 5 years post-surgery

Secondary Outcome Measure Information:

Title

Change from Baseline in the patient's evaluation of overall knee condition using the Modified Cincinnati Knee Rating System.

Description

The Change from Baseline will be evaluated.

Time Frame

6 months and 1,2 and 5 years post-surgery

Title

Change from Baseline in the patient's evaluation of pain using the Visual Analog Scale (VAS).

Description

The Change from Baseline will be evaluated.

Time Frame

6 months and 1,2 and 5 years post-surgery

Title

Change from Baseline in the patient's evaluation of overall knee condition using the International Cartilage Repair Society (ICRS) "Cartilage Injury Evaluation Package".

Description

The Change from Baseline will be evaluated.

Time Frame

6 months and 1,2 and 5 years post-surgery

Title

Adverse Events (AE) Review

Description

The incidence, timing, severity, and relationship to treatment of all Adverse Events (AE), will be collected for all participants.

Time Frame

5 years post-surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sven Anders, MD

Organizational Affiliation

University of Regensburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Regensburg

City

Bad Abbach

Country

Germany

Facility Name

Universitätsklinikum Freiburg

City

Freiburg

Country

Germany

Facility Name

Universitätsklinikum Giessen

City

Giessen

Country

Germany

Facility Name

Orthopedikum Hamburg

City

Hamburg

Country

Germany

Facility Name

Unfallklinik Hannover

City

Hanover

Country

Germany

Facility Name

University of Schleswig-Holstein

City

Lubeck

Country

Germany

Facility Name

Sportklinik Ravensburg

City

Ravensburg

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23730377

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.

Results Reference

result

PubMed Identifier

28108777

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.

Results Reference

result

Learn more about this trial

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

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