the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle

NCT02519881 | Unknown Phase 4 DMC

• 1 other identifier: 04CAR
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

This study was designed to evaluate the efficacy and safety of a modified microfracture using collagen, and to compare them with those of a simple microfracture in patients with cartilage defects in their ankles.

Conditions

Defect of Articular Cartilage

Keywords

cartilage defect in ankle; microfracture; modified microfracture using collagen; collagen

Outcome Measures

Primary Outcomes (1)

• 100mmVAS(visual analogue scale) score

  The VAS's were evaluated 12 months after the surgery on the affected ankle in the study and control groups.

  12 months after the surgery

Secondary Outcomes (7)

• Change score of 100mmVAS(visual analogue scale)

  Screening, 6, 12, and 24months after surgery

• Change of Satisfaction evaluation by patients

  Screening, 6, 12, and 24months after surgery

• Change of AOFAS(American orthopaedic foot & ankle society) Score

  Screening, 6, 12, and 24months after surgery

• Change of Hannover Score

  Screening, 6, 12, and 24months after surgery

• Change of Satisfaction evaluation by physician in charge

  Screening, 6, 12, and 24months after surgery

Study Arms (2)

modified microfracture using collagen

EXPERIMENTAL

modified microfracture using collagen (CartiFill) for cartilage defect of ankle

Procedure: Microfracture; Device: CartiFill

microfracture

ACTIVE COMPARATOR

simple microfracture for cartilage defect of ankle

Procedure: Microfracture

Interventions

Microfracture PROCEDURE

simple microfracture of ankle

microfracture; modified microfracture using collagen

CartiFill DEVICE

add collagen when doing microfracture

modified microfracture using collagen

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who were 15 years old or older
• Patients with cartilage defects in their ankle
• Patients with misalignment of their tibia and talus, unstable ligament in their ankle, or bony defects in the lesions of their ankle, and/or who had been treated for alignment
• Patients or their representative (for adults), or patients and their parent/guardian (for minors), who agreed to participate in the study and signed the informed consent form

You may not qualify if:

• If patients or their families suffer from or have ever suffered from an autoimmune disease.
• Patients who have ever suffered an anaphylactic reaction.
• Patients who have ever suffered hypersensitivity to an implant.
• Patients with a history of allergy to porcine or bovine protein.
• Subjects with inflammatory arthritis, such as rheumatoid and gouty arthritis.
• Subjects with autoimmune disease related arthritis.
• Subjects who are pregnant and/or breast-feeding and/or plan a pregnancy.
• Subjects with tumors.
• Subjects who have undergone radiotherapy or chemotherapy within the last 2 years (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
• Subjects who are diabetic. (Exception: if the possibility of CartiFill™ treatment is confirmed with doctor's clinical decision, and/or patient's blood glucose level remains within the normal range and/or no other complications by diabetes mellitus.)
• Subjects with infections, currently on treatment with antibiotics or antimicrobials (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
• Subjects under adrenocorticoid therapy (Exception: if the possibility of collagen treatment is confirmed with doctor's clinical decision).
• Subjects with psychiatric disorders who are considered inappropriate to participate in this trial by the Principal Investigator.
• Patients who have ever suffered contraindications of the used Fibrin sealant. (The major contraindications are as follows: patients with hypersensitivity to aprotinin and those treatments for severe brisk arterial or venous bleeding.)

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (3)

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, South Korea

RECRUITING

Eulji general Hospital

Seoul, Seoul, South Korea

RECRUITING

Hallym University Medical Center-Kangnam Sacred Heart Hospital

Seoul, Seoul, South Korea

RECRUITING

Related Publications (1)

• Lee YK, Young KW, Kim JS, Lee HS, Cho WJ, Kim HN. Arthroscopic microfracture with atelocollagen augmentation for osteochondral lesion of the talus: a multicenter randomized controlled trial. BMC Musculoskelet Disord. 2020 Nov 3;21(1):716. doi: 10.1186/s12891-020-03730-3.

  PMID: 33143647 DERIVED

MeSH Terms

Conditions

Fractures, Stress

Interventions

Arthroplasty, Subchondral

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Officials

• Jin Soo Kim, MD

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

• Young Hwan Kim, MD

  Soon Chun Hyang University

  PRINCIPAL INVESTIGATOR

• Hyung Nyun Kim, MD

  Hallym University Medical Center-Kangnam Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hyun Jo Kim, Bachelor

CONTACT

82-2-460-3237; angel@swcell.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2015
• First Posted: August 11, 2015
• Study Start: February 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2018
• Last Updated: August 11, 2015

Record last verified: 2015-08

Locations

KR (3)