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

T

The Catholic University of Korea

Status

Unknown

Conditions

Collagen Augmentation

Treatments

Procedure: Microfracture with Collagen Augmentation
Procedure: Microfracture without Collagen Augmentation

Study type

Interventional

Funder types

Other

Identifiers

NCT02685917
Collagen augmentation

Details and patient eligibility

About

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).

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

19 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

30 participants in 2 patient groups

Microfracture with Collagen Augmentation in HTO
Experimental group
Description:
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.
Treatment:
Procedure: Microfracture with Collagen Augmentation
Microfracture without Collagen Augmentation in HTO
Active Comparator group
Description:
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.
Treatment:
Procedure: Microfracture without Collagen Augmentation

Trial contacts and locations

0

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Central trial contact

Mansoo Kim, MD; Yong In, MD, PhD

Data sourced from clinicaltrials.gov

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