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

Effects of Microfracture With/Without Collagen Augmentation in Patients Undergoing High Tibial Osteotomy: A Randomized, Controlled, Double-Blind Trial

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).

Study Overview

• Status: Unknown
• Conditions: Collagen Augmentation
• Intervention / Treatment: Procedure: Microfracture with Collagen Augmentation; Procedure: Microfracture without Collagen Augmentation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Microfracture with Collagen Augmentation; Cartifill applied for collagen augmentation
Active Comparator: 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.	Procedure: Microfracture without Collagen Augmentation; Cartifill applied for collagen augmentation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
knee Injury and Osteoarthritis Outcome Score (KOOS)	Change from Baseline score to score of postoperative 1 year.
International Knee Documentation Committee (IKDC) score	Change from Baseline score to score of postoperative 1 year.
Tegner score	Change from Baseline score to score of postoperative 1 year.

Secondary Outcome Measures

Outcome Measure	Time Frame
The MRI observation of cartilage repair tissue (MOCART) score	Preoperative & postoperative 1 year.
International Cartilage Repair Society (ICRS) II scoring system	Postoperative 1 year.

Collaborators and Investigators

• Sponsor: The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: February 11, 2016
• First Submitted That Met QC Criteria: February 14, 2016
• First Posted (Estimate): February 19, 2016

Study Record Updates

• Last Update Posted (Estimate): February 19, 2016
• Last Update Submitted That Met QC Criteria: February 14, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Fractures, Stress
• Other Study ID Numbers: Collagen augmentation