Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy

NCT ID: NCT02685917

Last Updated: 2016-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29

Brief Summary

The quality of cartilage regeneration after marrow stimulation is well documented to be unpredictable, because they do not regenerate consistent amount of cartilage. To overcome the shortcomings of the microfracture technique, various augmentation techniques using synthetic collagen matrix, scaffolds or plug devices have been developed. However, their efficacy remains unclear. The purpose of this prospective randomized controlled study is to evaluate whether the microfracture in combination with collagen gel augmentation could improve the quality of cartilage regeneration in patients undergoing medial open wedge high tibial osteotomy (HTO) for the treatment of medial unicompartmental knee osteoarthritis (OA).

Detailed Description

CartiFill™ (atelocollagen, Sewon Cellontech, Seoul, Korea) was developed to to provide a matrix stability and to maintain the blood clot in the defect site, which promoted the cartilage regeneration by mesenchymal stem cell . It was a atelocollagen, highly purified porcine derived type collagen І that has been modified to virtually eliminate the risk of rejection by removal of telopeptide.

The investigators randomized patients undergoing HTO in combination with microfracture to receive either microfracture alone (control group, n = 5) or microfracture with collagen augmentation (experimental group, n=6). At postoperative one year, the clinical outcome in terms of Visual Analogue Scale of pain level (VAS), Knee Injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, and Tegner scores were evaluated. In addition, second look arthroscopic examination and biopsy of regenerated cartilage were carried out when the HTO plate was removed at postoperative one year. Biopsy specimens were graded by International Cartilage Repair Society Visual Assessment Scale (ICRS II scores). Finally, radiologic outcome in terms of Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores was assessed using follow up MRI undertaken at postoperative one year.

Conditions

Collagen Augmentation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Microfracture with Collagen Augmentation in HTO

Two groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture.

Group Type: EXPERIMENTAL

Microfracture with Collagen Augmentation

Intervention Type: PROCEDURE

Cartifill applied for collagen augmentation

Microfracture without Collagen Augmentation in HTO

Two groups, either collagen augmentation or not. Firstly, all patients underwent an arthroscopic examination and microfracture for bone marrow. Collagen augmentation included Cartifill insertion after arthroscopic microfracture.

Group Type: ACTIVE_COMPARATOR

Microfracture without Collagen Augmentation

Intervention Type: PROCEDURE

Cartifill applied for collagen augmentation

Interventions

Microfracture without Collagen Augmentation

Cartifill applied for collagen augmentation

Intervention Type: PROCEDURE

Microfracture with Collagen Augmentation

Cartifill applied for collagen augmentation

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Aged below 65 years with isolated medial compartment osteoarthritis
• Good range of motion
• No ligament instability
• Having medicare insurance

Exclusion Criteria

• Diagnosis of severe tricompartment osteoarthritis indicated for total knee arthroplasty
• Inflammatory arthritis(rheumatoid arthritis), osteonecrosis
• Flexion contracture ≥ 15°
• Knee range of motion < 120°
• Joint instability
• A history of knee joint infection and who refused to participate

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Catholic University of Korea

OTHER

Sponsor Role: lead

Responsible Party

Yong In

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yong In, MD, PhD

Role: STUDY_CHAIR

the Catholic Univerisity of Korea Seoul St Mary's hospital

Central Contacts

Yong In, MD, PhD

Role: CONTACT

iy1000@catholic.ac.kr

8290445228

Mansoo Kim, MD

Role: CONTACT

kms3779@naver.com

8272333875

Other Identifiers

Collagen augmentation

Identifier Type: -

Identifier Source: org_study_id