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

NCT ID: NCT02993510

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31
• Study Completion Date: 2016-07-31

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.

Conditions

Cartilage Injury; Osteochondritis Dissecans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

microfracture

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

Group Type: ACTIVE_COMPARATOR

Microfracture

Intervention Type: PROCEDURE

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 with Chondro-Gide sutured

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

Group Type: EXPERIMENTAL

Chondro-Gide sutured

Intervention Type: DEVICE

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

Microfracture with Chondro-Gide glued

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

Group Type: EXPERIMENTAL

Chondro-Gide glued

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: PROCEDURE

Chondro-Gide sutured

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

Intervention Type: DEVICE

Chondro-Gide glued

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Geistlich Pharma AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sven Anders, MD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

University of Regensburg

Bad Abbach, , Germany

Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

Universitätsklinikum Giessen

Giessen, , Germany

Orthopedikum Hamburg

Hamburg, , Germany

Unfallklinik Hannover

Hanover, , Germany

University of Schleswig-Holstein

Lübeck, , Germany

Sportklinik Ravensburg

Ravensburg, , Germany

Countries

Germany

References

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.

Reference Type: RESULT

PMID: 23730377 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28108777 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38630297 (View on PubMed)

Other Identifiers

10830-003

Identifier Type: -

Identifier Source: org_study_id