Retrospective Analysis of coflex : Long-term Cohort in 240 Patients

Transcription

1 Retrospective Analysis of coflex : Long-term Cohort in 24 Patients Dieter Adelt Damp, Germany

2 Degenerative Spinal Stenosis Disease of Facet Joints! Damaged Cartilage Synovitis / Synovial Cysts Osteophyte Formations Subchondral bone cysts Capsule/Ligament Relaxation Subluxations Hypothesis: coflex allows for Stabilization after neural Decompression reducing Back Pain without Fusion. Implantation of coflex reduces the ROM in Extension undloading the Facet Joints and maintaing foraminal Height.

3 Implantation Technique brings Implant close to anatomical COR Implant Design increases this Effect Range of Motion of Facet Joints can be controlled Rotational Forces influenced due to Wing Concept Large Contact Surface New Possibilites for Therapy of Facet Arthrosis

4 Retrospective Data Analysis: Patient Accountability Patients Identified (Total number) Evaluable Patients (CRFs and x-rays completed) % Follow-Up Median Follow Up for evaluable patients (months) To Be Scheduled Refused Follow-Up Deceased Unable To Locate Other %

5 Accountability Flow Chart Patients with Completed CRF s and X rays 26 ( %) Topping Off 2 (6 %) Stenosis 54 (75 %) HNP 4 (9 %)

6 54 Patients Treatment Subgroups Group I : level decompression - coflex Group II : 2 levels decompression - 2 coflex Group III : 2 levels decompression - coflex Group IV : Additional * * 2 level implantation and level decompression- 2, level implantation and 3 level decompression 3, 2 level implantation and 3 level decompression 2, 2 level implantation and 4 level decompression

7 Preoperative walking distance <m in 89% of the patients N= 54 I ( n= ) II (n= 27) III (n= 8) IV (n=8) < 2 m 4 (26. %) 8 (5.2 %) (7. %) 5 (3.2 %) Preoperative Walking Distance > 3 m 46 (29.9 %) 8 (.7 %) 6 (3.9 %) 3 (.9 %) Percent calculation relative to total spinal stenosis population > m (6.5 %) (.6 %) (.6 %) ( %) >2 m 5 (3.2 %) ( %) ( %) ( %)

8 Walking Distance Improvement of 87% (>m) Postoperative Walking Distance N= 54 Improved Same Worse Total (n=54) 34 (87. %) 9 (2.3 %) (.6 %) I (n= ) 85 5 II (n= 27 ) 24 3 III (n= 8) 7 IV (n=8) 8

9 Moderate and severe LBP in 59% (92/54) N= 54 None Preoperative Low Back Pain mild moderate severe I (n= ) 26 (6.9 %) 2 (3. %) 44 (28.6 %) (7. %) II (n= 27) 5 (3.2 %) 2 (.3 %) 7 (. %) 3 (.9 %) III (n= 8) 3 (.9 %) 4 (2.6 %) (6.5 %) (.6 %) IV (n=8) (.6 %) (.6 %) 4 (2.6 %) 2 (.3 %) Percent calculation relative to total spinal stenosis population

10 Postoperative LBP Total # Improved No Pain Same Worse Total (n=92) 66 (7.7%) 37 (4.2 %) 22 (23.9 %) 4 (4.3 %) I (n=55) 39 (7.9 %) 8 (32.7 %) 5 (6.3%) (.8 %) II (n=2) 3 (65.%) 9 (45) 4 (4.2%) 3 (3.3%) III (n=) (9. %) 8 (72.7 %) (. %) ( %) IV (n=6) 4 (66.7%) 2 (33.3 %) 2 (2.2 %) ( %)

11 Reintervention I (n= ) II (n= 27) III (n= 8) IV (n=8) CSF Leak Seroma (.6 %) (.6 %) Deep Infection Superficial Infection Wound Dehiscence Fusion Needed 2 (.3 %) (.6 %) HNP (Recurrent) (.6 %) HNP (New Level) (.6 %) Other Percentages relative to total stenosis patients

12 Worsening Neurological Motor (.6 %) Sensory (.6 %) (.6 %) Reflex New Deficit Neurological Motor Sensory Reflex Percententages relative to total stenosis patients

13 out of 54 patients had adverse events not related to the coflex device (6.5%) Non of the adverse events were significant or caused a dramatic permanent change in patient function No postoperative CSF leaks No deep or superficial infections No wound healing problems Safety Data

14 Device Related N= 54 I (n= ) II (n= 27) III (n= 8) IV (n=8) Broken U Deformed U Dislocated U Migrated U (.6 %) Broken Wing Spinous Process Fx Removed U 2 (.3 %)

15 Extremely low rate of device related complications No broken implant No plasitcally deformed implant No dislocations Secure enough fixation to prevent extrusion Two implant removals (.3%) Neither of the removals were secondary to device failures

16 Patient Satisfaction = 9 % N= 54 Very Satisfied Satisfied Not Satisfied I (n=) 56 (55.4 %) 35 (34.7 %) (9.9 %) II (n=27) 5 (55.6 %) 9 (33.3 %) 3 (. %) III (n=7)* 2 (7.6 %) 5 (29.4 %) ( %) IV (n=8) 7 (87.5 %) (2.5 %) ( %) Percent calculation relative to subgroups * missing response

17 Patient Satisfaction remains stable over time N= 54 Very Satisfied Satisfied Not Satisfied 6 to 2 mo (n= 58) 35 (6.3 %) 9 (32.8 %) 4 (6.9 %) >2 to 24 mo (n= 53) 3 (56.6 %) 7 (32. %) 5 (9.4 %) > 24 mo (n= 43) 25 (58. %) 4 (32.6 %) 4 (9.3 %) Percent calculation relative to subgroups Total: 9%

18 Would you have surgery again? N= 53 * I (n=) II (n= 27) III (n=7) IV (n=8) Yes 94 (93. %) 26 (96.3 %) 7 ( %) 8 ( %) No 7 (6.9 %) (3.7 %) ( %) ( %) Percent calculation relative to subgroups * missing response YES = 94,2 %

19 Summary 72% Improvement of low back pain 4% showed complete relief Significant improvement of walking distance 89% of patients preop < m 87% of patients showed improvement postop High rate of patient satisfaction 9% satisfied or very satisfied 94% would have surgery again

20 Conclusion Retrospectively coflex proved to be safe and effective Possibility to not only address Leg Pain but also Back Pain Prospective Data needed to verify these promising findings.

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