Rotator Cuff Repair Time: The AutoCuff System vs. Conventional Arthroscopic Repair Lawrence Lemak, MD and David Lemak, MD

Transcription

1 Rotator Cuff Repair Time: The AutoCuff System vs. Conventional Arthroscopic Repair Lawrence Lemak, MD and David Lemak, MD Alabama Sports Medicine and Orthopedic Center, Birmingham, AL

2 Abstract All-arthroscopic rotator cuff repair is an appealing option for many and for surgeons who offer the procedure. Nonetheless, the conventional all-arthroscopic repair does pose some drawbacks, including the complexity of knot-tying and the amount of time needed to complete the repair. The purpose of this prospective case series was to evaluate rotator cuff repair time for 50 consecutive undergoing repair using the AutoCuff System as performed by an experienced surgeon. The results were compared to a published prospective series of 100 receiving conventional all-arthroscopic rotator cuff repair 1. The results of our study suggested that average rotator cuff repair time using the AutoCuff system could potentially be reduced by three-fold from an average of greater than 30 minutes to less than 10 minutes. The AutoCuff System The AutoCuff system with the SmartStitch suturing device (Figure 1) and Magnum implant inserter handle (Figure 2) is designed to facilitate arthroscopic rotator cuff repair by obviating the need for mastery of traditional arthroscopic knot-tying techniques. The SmartStitch suturing device is an integrated grasper and suturing device that allows the surgeon to grasp the cuff tissue and place an Incline Mattress stitch in seconds. The AutoCuff system achieves a knotless intra-osseus suture fixation using the Magnum implant. The implant achieves a strong subcortical bone lock, provides a ratchet mechanism to transport the rotator cuff tissue to the prepared footprint, and applies and maintains tension on the sutures for an optimal cuff to footprint interface. Figure 1. SmartStitch and tip close-up Figure 2. Magnum implant Purpose of the Study This prospective case series study was performed to compare the efficiency of the AutoCuff system to conventional all-arthroscopic rotator cuff repair in relatively similar populations treated by surgeons skilled in each respective technique. It was hypothesized that the AutoCuff system may offer a time savings benefit over traditional all-arthroscopic rotator cuff repair. The AutoCuff system eliminates the challenge of placing manual stitches allarthroscopically and tying knots. Rotator cuff repair time for 50 using the AutoCuff system was compared to rotator cuff repair time as reported previously by Guttman and colleagues for 100 who were consecutively treated using conventional all-arthroscopic rotator-cuff repair 1. 2

3 Patient Demographics and Procedure Data The study was designed to evaluate rotator cuff repair time once the surgeons had achieved proficiency in their approach to performing rotator cuff repair. The study did not account for the time it takes to position and drape the patient or other related pre-op or post-op tasks. Both study groups had similar age range and most were male (Table 1). Using the AutoCuff System, no broken knots or sutures, or anchor pull-outs were observed (Table 2). The finished repair using the AutoCuff System provided a knotless subcortial fixation (Figure 3). The AutoCuff System enabled the cuff tissue to be lateralized to the footprint for good tissue to bone interface (Figure 4). Arthroscopic Repair using AutoCuff (Lemak et al) Arthroscopic Repair using Conventional Knot Tying (Guttman et al) Age 56 (39 81 years) 57 (33 85 years) Gender Male 36 (72%) 65 (65%) Female 14 (28%) 35 (35%) Tear Size Small (<1 cm) 0 7 (7%) Medium (1 to 3 cm) 49 (99%) 39 (39%) Large (3 to 5 cm) 6 (3%) A 30 (30%) Massive (>5 cm) 0 24 (24%) A 5 cases were classified as having tears of 3 cm Arthroscopic Repair using AutoCuff (Lemak et al) Arthroscopic Repair using Conventional Knot Tying (Guttman et al) Surgical experience (# cases before starting the study) >50 3 Stitch/knot type used Mattress 50 (100%) 0 Side-to-side w/sliding knot (100%) Number of anchors placed per procedure 1 18 (36%) Information not reported 2 29 (58%) Information not reported 3 or 4 3 (6%) Information not reported Broken knot or suture 0 Cases = 6 Cases = 0 Anchor pull-out 0 1 (1%) Table 1. Patient Demographics Table 2. Operative Data Figure 3. Finished Repair Figure 4. Incline Mattress Stitch 3

4 Rotator Cuff Repair Time Individual Case Times For the 50 receiving rotator cuff repair using the AutoCuff System, repair time ranged between 3 and 15 minutes (Figure 4). In the Guttman et al., 100-patient series, rotator cuff repair times ranged between 10 minutes and 150 minutes; for the last 50, after the surgeon had gained a higher level of proficiency, individual cuff repair times ranged from 10 to ~100 minutes 1. Rotator Cuff Repair using AutoCuff time (minutes) Individual Cases Figure 4. Rotator cuff repair time for the 50 individual cases treated using the AutoCuff System ranged between 3 and 15 minutes. Average Repair Time for Consecutive 10-Patient Sets The average rotator cuff repair time for each consecutive 10-patient set undergoing repair using the AutoCuff System ranged between 5 and 9 minutes (Figure 5). The mean time for completing rotator cuff repair for each consecutive 10-patient set in the Guttman et al., group ranged from 30 to 40 minutes. time (minutes) Mean (±SD) Time for Rotator Cuff Repair AutoCuff Conventional Figure 5. Rotator cuff repair time (mean ±SD) for patient sets of 10 cases treated using the AutoCuff system took substantially less time than conventional arthroscopic repair 1. The AutoCuff represent consecutive cases treated by an experienced surgeon who had already performed >50 AutoCuff cases before initiating this study. The Guttman et al., series shown in the figure represent cases 51 through

5 Using the AutoCuff System, mean repair time for medium (7±3 minutes) and large (11±3 minutes) tears differed significantly (p<0.05; Figure 6). For receiving 1 anchor (n=18), 2 anchors (n=29), and 3 or 4 anchors (n=3), respectively, mean repair times were 4±1 minutes, 9±1 minutes, and 13±4 minutes. No anchor pull-outs or other significant perioperative events were observed in the receiving rotator cuff repair using the AutoCuff System. time (minutes) Rotator Cuff Repair Time by Tear Size: the AutoCuff System small (<1 cm) medium (1 to 3 cm) Rotator cuff repair time large (3 to 5 cm) massive (>5 cm) Figure 6. Using the AutoCuff System, the average time required to repair a medium sized tear was about 7 minutes and for a large sized tear was about 11 minutes. Discussion Just under 50% of rotator cuff repairs in the United States are performed all-arthroscopically. In many cases, all-arthroscopic rotator cuff repair is preferable to full-open or mini-open procedures since arthroscopic repair is less invasive and surgical access to underlying structures may be facilitated 2. Yet all-arthroscopic rotator cuff repair still has a number of drawbacks such as potentially insufficient bone-tendon fixation and technical difficulty 2, and as the arthroscopic procedure becomes more prevalent, these drawbacks become more of a concern. Some of the major technical challenges for performing the procedure allarthroscopically include optimal suture placement, ability to place the best type of knot, and managing multiple sutures. The consistently shorter repair time using the AutoCuff System may be a result of the simplified suture passing and knotless fixation provided by the AutoCuff System. Rotator cuff repair using the AutoCuff System is an appealing alternative to traditional all-arthroscopic rotator cuff repair in that it can be performed in much less time. The marked savings in time realized using the AutoCuff System have far-reaching ramifications in terms of improved physician and operating room time, and improved efficiency. Surgeons can optimize operating room time, which can translate into higher patient throughput. In addition, with a rotator cuff repair using the AutoCuff System, may benefit from shorter anesthesia time compared to the conventional all-arthroscopic repair, and other complications of a prolonged arthroscopic surgery (i.e., extravisation). Further research should be conducted to determine whether the AutoCuff System may offer superior efficacy in terms of repair strength and postoperative recovery time compared to traditional all-arthroscopic rotator cuff repair as well as the significant time savings demonstrated by this prospective case series study. 5

6 References 1. Guttman D. Graham RD. MacLennan MJ. Lubowitz JH. Arthroscopic rotator cuff repair: the learning curve. Arthroscopy 2005; 21: Yamaguchi K. Levine WN. Marra G. Galatz LM. Klepps S. Flatow EL. Transitioning to arthroscopic rotator cuff repair: the pros and cons. Instr. Course Lect. 2003; 52: ArthroCare Corporation 680 Vaqueros Avenue Sunnyvale, CA main phone order entry order entry fax arthrocaresportsmedicine.com ArthroCare Europe AB Skeppsbron Stockholm Sweden phone fax info@arthrocare.se CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician ArthroCare Corporation. ArthroCare, AutoCuff, SmartStitch, Incline Mattress, and Magnum are trademarks and/or registered trademarks of ArthroCare Corporation. P/N A1038 Rev B