NCT02993510

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2003

Longer than P75 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
12 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2016

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

12 years

First QC Date

December 2, 2016

Last Update Submit

February 20, 2017

Conditions

Cartilage InjuryOsteochondritis Dissecans

Keywords

microfractureenhanced marrow stimulationarticular cartilageAutologous Matrix-Induced ChondrogenesisChondro-Gide®knee surgeryAMIC

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

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

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

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

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

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

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

  • Adverse Events (AE) Review

    5 years post-surgery

Study Arms (3)

microfracture

ACTIVE COMPARATOR

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

Procedure: Microfracture

Microfracture with Chondro-Gide sutured

EXPERIMENTAL

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

Device: Chondro-Gide sutured

Microfracture with Chondro-Gide glued

EXPERIMENTAL

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

Device: Chondro-Gide glued

Interventions

MicrofracturePROCEDURE

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

microfracture
Chondro-Gide suturedDEVICE

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

Microfracture with Chondro-Gide sutured
Chondro-Gide gluedDEVICE

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

Microfracture with Chondro-Gide glued

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Regensburg

Bad Abbach, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Giessen

Giessen, Germany

Location

Orthopedikum Hamburg

Hamburg, Germany

Location

Unfallklinik Hannover

Hanover, Germany

Location

University of Schleswig-Holstein

Lübeck, Germany

Location

Sportklinik Ravensburg

Ravensburg, Germany

Location

Related Publications (3)

  • 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.

    PMID: 23730377RESULT

  • 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.

    PMID: 28108777RESULT

  • Volz M, Schaumburger J, Gellissen J, Grifka J, Anders S. A randomized controlled trial demonstrating sustained benefit of autologous matrix-induced chondrogenesis (AMIC(R)) over microfracture: 10-year follow-up. Eur J Orthop Surg Traumatol. 2024 Jul;34(5):2429-2437. doi: 10.1007/s00590-024-03948-0. Epub 2024 Apr 17.

    PMID: 38630297DERIVED

MeSH Terms

Conditions

Osteochondritis DissecansFractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

OsteochondritisBone DiseasesMusculoskeletal DiseasesFractures, BoneWounds and Injuries

Intervention Hierarchy (Ancestors)

ArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery Procedures

Study Officials

  • Sven Anders, MD

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 15, 2016

Study Start

December 1, 2003

Primary Completion

December 1, 2015

Study Completion

July 1, 2016

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(7)