Analysis of 3D Knee™ & Clinical Outcomes at 5 Years

1. Analysis of 3D Knee™ & Clinical Outcomes at 5 Years WA Hodge1,2, MK Harman2, A. Mori2, SA Banks2,3,4 1Hodge BioMotion Orthopaedics, Good Samaritan Medical Center, West Palm Beach, FL, USA 2Institute for Mobility & Longevity, West Palm Beach, FL, USA 3Dept. of Mechanical & Aero Engineering, Univ. of Florida, Gainesville, FL, USA 4Dept. of Orthopaedics & Rehabilitation, Univ. of Florida, Gainesville, FL, USA Research grants have been received in support of these studies. One or more authors are paid consultants and/or receive royalties from DJO Surgical (Encore Medical).

2. The Insttute ofLongevity & Mobility Palm Beach, FL USA

3. Hodge Background • 1974 Undergraduate Engineering • 1978 Orthopaedic Residency: Galante/Andriacchi • 1982 Fellowship: Harvard/MIT-William H Harris • 1984 Massachusetts General Hospital-Dir.Biomech Lab • 1988 Prof at MIT-PhD Committee for Dr Scott Banks • 1992 Good Samaritan Hospital-Founds BioMotion Res. • 1994 Patents 3D Knee • 1999 Establishes Saudi Arabian Office • 2001 Implants first 3D Knee • 2008 Joins Scripps Research Institute: Scripps-Florida

4. Why Knees Fail? • 212 consecutive revised TKA, 1997-2000 • Sharkey et al., CORR, 404, 2002

5. Lateral Medial VALGUS Flexion Flexion VARUS ACL Deficient Knee • Arthritis and Wear • Posterior of medial tibial surface (varus) • Posterior lateral tibial(varus) • Kinematics • Anterior sliding of medial condyle with knee flexion(lateral condyle in red) • Femoral external rotation with flexion

6. Key Observations PCL-retaining TKR exhibit lateral pivot kinematics. Lateral Medial Medial Lateral Left TKR Right TKR

7. Rationale Since 2001, we have used an ‘Cruciate Substituting’ TKA design with articular surfaces configured to approximate the function of the cruciates. Goal To determine if an ‘Cruciate-substituting’ TKA design can restore patient strength and stability, providing clinical and functional results comparable to or greater than traditional TKA designs.

8. Dictates a pivot type tibial insert Lateral stability Why Rotate Laterally? • Provide intrinsic AP stability throughout gait/stair range • Provide free axial rotation ±15° • Fixed-bearing design • Permit EASY retain/resect the PCL when desired • Restore posterior condylar offset in deep flexion 3D Knee

9. 30,000 3Ds Implanted

10. 3D Knee™ Longevity & Wear

11. 956 knees in 781 patients Avg. follow-up: 5.5 (5-7) years surgery 2002 – 2004 44% males, 56% females Age: 69+8 (33-93) years Weight: 81+16 (50-120) kg BMI: 28+5 (20-40) Diagnosis OA – 90% knees RA – 10% knees Initial 956 ‘ACL substituting’ TKR with 5-7 Year Follow Up

12. Results – Kneeling & Lunge • Fully congruent lateral compartment controls tibiofemoral motion near extension, but allows femoral rollback in flexion • Constant sagittal profile and posterior center of femoral rotation provides a longer quadriceps moment arm Kneeling Lunge p-value Skeletal Flexion (deg) 131°±13° 120°+11° <0.05 Tibial Int. Rot (deg) 10°±4° 11°±4° n.s. Med. Condyle AP (mm) -12±4 0±4 n.s Lat. Condyle AP (mm) -10±4 -0±4 n.s Lunge Kneeling

13. Knee Society Score (pain, function) Range of motion “Digital Goniometer” tool for computerized measurement of digital radiographs Outcome Measures JR090 at 2 yrs.

14. Knee Society Scores (Pain/Motion) 5 years 2 year 3 year 1 year 98+4 3 mos 97+7 96+7 97+5 100 92+11 80 Pre-Op 60 47+11 40 20 0 Mean Knee Society Score (Pain/Motion)

15. Knee Society Scores (Function) 5 years 2 year 3 year 1 year 95+10 97+7 95+11 95+12 100 3 mos 85+20 80 Pre-Op 60 51+12 40 20 0 Mean Knee Society Score (Function)

16. Passive Flexion 5 years 130 2 year 3 year 1 year 121+10 121+10 121+10 119+10 3 mos 120 113+12 Pre-Op 107+8 110 100 90 80 Mean Passive Flexion (deg) At last follow-up, 68% have > 120° of flexion

17. Thank You West Palm Beach, Florida USA