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Clinical Evaluation of A Novel Reconstruction Device for Osteonecrotic Femoral Head

Clinical Evaluation of A Novel Reconstruction Device for Osteonecrotic Femoral Head. Ching-Chuan Jiang M.D., Ph.D., M.B.A. Arthropathy Research Laboratory. Osteonecrosis of Femoral Head.

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Clinical Evaluation of A Novel Reconstruction Device for Osteonecrotic Femoral Head

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  1. Clinical Evaluation of A Novel Reconstruction Device for Osteonecrotic Femoral Head Ching-Chuan Jiang M.D., Ph.D., M.B.A. Arthropathy Research Laboratory

  2. Osteonecrosis of Femoral Head • Out of all total hip replacements in the US and Europe, 10% are caused by osteonecrosis with approximately 300,000 to 600,000 casesof osteonecrosis of femoral head in the US every year. • Asian area has a higher rate as 50%oftotal hip replacements are due to osteonecrosis.

  3. MRI Staging of Osteonecrotic Femoral Head Stage I Normal radiograph Stage II Femoral head Lucency/sclerosis on radiograph Stage III Subchondral collapse without femoral head flattening, “crescent sign“ Stage IV Subchondral collapse, femoral head flattening, normal joint space Stage V Flattening with joint space narrowing, acetabular changes, or both Stage VI Advanced degenerative changes, secondary osteoarthritis

  4. Knee and extremity joints cartilage repair technologies • (Biphasic Cartilage Repair Implant,BiCRI) have been transferred to Exactech in 2008. Progresses and results were reported in the ongoing clinical trial. • Applications on indications related to hip joint, craniofacial and spine are still retained in NTUH/ITRI and not yet being transferred. Clinical Trial: Efficacy Evaluation of ONFH Reconstruction Device

  5. Current Patent Status • P56980010US, temporary application no.:12/830,536. Patent name： Bone Repairing Kit and Method for Bone Repair • P56980010TW, Patent no.:I413504 Patent name：骨修復套組

  6. Patents for Biphasic Matrix • Process for producing porous polymer materials, US Pat. No • 6,436,426 • Method for tissue culture in vitro, US Pat. No 6,884,621 • Process for producing porous polymer materials, US Pat. No • 6,824,716 • Method and carrier for culturing multi-layer in vitro, I255852 • Tissue pulverizer, I 255738 • Multi-layered matrix, method of tissue repair using the same, • and multi-layered implant prepared thereof, US Pat. Revised. • Filtration and collection device for tissue and cells, US Pat. • Filing. Seven patents have been issued.

  7. Clinical Efficacy Evaluation of ONFH Device

  8. Subjects selection Preoperative evaluation Standard Operating Procedure Control (core decompression) Experimental (ONFH Repair Device) Postoperative evaluation and data analysis Planned to operate 20 cases: Including 10 in control group (core decompression) and 10 inexperimental group (ONFH device)

  9. Recruitment status: • I.Inclusion criteria： • No allergies. • No critical illness. • 20 – 70 years old. • Shape of the femoral head is generally preserved and the lesion diameter is less than 1.8 cm on radiographs, CT and MRI scans. • MRI Staging III lesion.

  10. II. Exclusion criteria: • Prior surgical treatment of the lesion. • Pregnancy. • Extensive degenerative hip arthritis. • Osteoporosis in femoral head and neck. • Rheumatoid arthritis and other inflammatory arthritis of hip. • Hip stiffness, defined as: • Flexion < 20 degrees. • Internal rotation < 90 degrees. • Lesions: MRI Staging IV, V and VI.

  11. III. The evaluation methods: • Assess the subchondral bone and articular cartilage by MRI.

  12. IV. Experiment time schedule: Evaluation methods Post surgery Follow up (weeks)

  13. V. Data collection and Statistical analysis: • DATA collection between pre- and post-surgery: • Hip range of motion • Harris Hip Score • WOMAC (The Western Ontario and McMaster Universities) Osteoarthritis index • VAS(Visual Analogue Scale) • Statistical analysis: • One-tailed Student’s t-test: Hip range of motion, VAS • Wilcoxon Rank Sum test: Harris Hip Score, WOMAC

  14. Pre-Clinical Animal Study Development of implantable scaffold and surgical instrument completed • Cannulated reamer • Ejector • Holder • Trimmer • Resorbable Bone Substitute Hip joint reconstruction surgical instrument and implantable scaffold Design and development of surgical procedure and 8 porcine large animalimplantation tests completed; articular cartilage and bone at femoral head can be reconstructed and repaired.

  15. Patient profile Case # 01 (Op: 2013.08.29) • 37 y/o female • Wt / Ht: 72kg / 158.2cm • Diagnosis: Osteonecrosis of femoral head, right hip • Complaint: right hip pain for 8 months • History: steroid used 2 years for Vasculitis • OP Method: A novel reconstruction device

  16. Case# 01 X-Ray Pre-OP Post-OP 6weeks Post-OP 3months

  17. Case# 01 Pre-OP MRI

  18. Case # 01 Operation Findings

  19. Patient profile Case # 02 (Op: 2013.10.24) • 56 y/o female • Wt / Ht: 57.8kg / 163.6cm • Diagnosis: Osteonecrosis, left femoral head • Complaint: Left hip pain for 6 months • History: HB carrier, liver abscess • OP Method: A novel reconstruction device

  20. Case# 02 X-Ray Post-OP 6 weeks Pre-OP

  21. Case# 02 Pre-OP MRI

  22. Case # 02 Operation Findings

  23. Case # 02 Tissue and Histology Section A Section B 40x 40x 1 cm 100x 400x 400x

  24. Patient profile Case # 03 (Op:2013.12.05) • 29 y/o female • Wt / Ht: 53.6kg / 162.3cm • Diagnosis: Osteonecrosis, left femoral head • Complaint: 1.Low back pain with frequent soreness 2.decreased range motion and pain at left hip for 2 years • History: Not contributory • OP Method: Core decompression

  25. Case# 03 X-Ray Pre-OP Immediate Post-OP

  26. Case# 03 Pre-OP MRI

  27. Case # 03 Operation Findings

  28. Functional Results: WOMAC VAS

  29. Preliminary Conclusions • Two patients of the experiment group (osteonecrotic • device) and one patient of the control group (core • decompression) were performed uneventfully. • No perioperative complications occurred. • Immediate pain relieve in three patients of both groups • were observed. • The experimental procedure can provide a minimal • invasive endoscopic approach for direct visual examination • to the lesion site. It also open a venue for further • therapeutic managements to the osteonecrotic femoral • head.

  30. Acknowledgement • National Taiwan University College of Medicine: Hongsen Chiang, Jyy-Jih Tsai, Chang-Hsun Hsieh, Chia-Jung Tsai, Sy-Chi Chen, Ya-Pin Wu, Rung-Shan Lee • Industrial Technology Research Institute: Chun-Jen Liao, Wen-Hsiang Chang, Huang-Chi Chen, Huang-Chi Chen, Ming-Chia Yang, Wei-Ju Liao , Yun-Han Lin , Chia-Chi Ho, Wei-Hong Chang, Ping-Chung Chang, Fang-Jie Jang, Chi-Hsiang Liao • Intai Technology Corp • Financial Support: NRPB,ITRI,NTUH

  31. Thank You for Your Attention

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