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Suture anchor Bone Response Validation Study

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Suture anchors are routinely used for shoulder labral reconstruction procedures. There is paucity of literature on how the response of bone to suture anchor should be measured following labral reconstruction. A new system, based on the use of magnetic resonance (MR) imaging, has been developed by Professor Bhatti and his trainee which grades bone signal changes around suture anchors using a five-point scale. This system, however, has not yet been tested on a clinical dataset. We tested the reliability of the grading system in an independent dataset.
This validation study demonstrates that the grading system is feasible and has generally moderate reliability. And, although results could be improved if a training document is added at the beginning of the study, this grading system should undergo further validation testing for use in clinical trials.

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Suture anchor Bone Response Validation Study

  1. 1. VALIDATION OF A NOVEL GRADING SYSTEM TO ASSESS BONE RESPONSE AROUND SUTURE ANCHORS FOLLOWING SHOULDER LABRAL RECONSTRUCTION Haseem Raja Professor Lennard Funk, Professor Waqar Bhatti
  2. 2. INTRODUCTION GLENOID LABRUM - Ring of fibrous cartilage that surrounds the glenoid - Increases contact surface area between glenoid and humeral head - Limits humeral head translation - Increases overall depth of glenoid fossa - Adds to the stabilising effect of LHB REASON FOR LABRAL TEARS - Trauma, e.g. shoulder dislocations - Overhead throwing or hitting athletes - Global laxity - Natural degeneration with age
  3. 3. BRIEF LITERATURE REVIEW • Suture anchors are routinely used for shoulder labral reconstruction procedures. • There is paucity of literature on how the response of bone to suture anchor should be measured following labral reconstruction. • A new system, based on the use of magnetic resonance imaging (MRI), has been developed by Professor Bhatti and his trainee which grades bone signal changes around suture anchors using a five-point scale. This system has yet to be tested on a clinical dataset. GRADE SIGNAL ON T1 SIGNAL ON T2FS HYPOTHESIS 0 Normal Normal Normal post- surgical change up to 6 months.1 Normal Minimal bony oedema 2 Low Mild oedema 3 Low Cystic change Potentially unstable4 Low Fluid surrounding anchor
  4. 4. AIMS OF STUDY 1. To calculate interrater reliability for the musculoskeletal radiologists and shoulder surgeons. 2. To calculate interrater reliability between the musculoskeletal radiologists and shoulder surgeons. 3. To assess intrarater reliability among the raters. Support the translation of the grading system to a novel study that compares the overall bone response of an all-suture anchor with a biocomposite anchor following shoulder labral reconstruction.
  5. 5. METHODS 1. A total of 10 patients were included in this validation study, amounting to a total of 36 suture anchors. 2. MRI scan sequences (T1 and T2FS) for each suture anchor were carefully selected for scoring and compiled in a PowerPoint presentation. All patient details were hidden. These images were subsequently verified by a consultant MSK radiologist for being eligible to score. 3. An email containing the presentation with images of 31 suture anchors, including boxes for comments and grading, were sent to 9 clinicians (6 MSK radiologists and 3 shoulder surgeons). 4. One week after the first grading, each rater entered the second phase of scoring and received a second email with a new presentation, containing the same images in an automatically randomised different order with a different number to prevent any recall bias. 5. The clinicians agreed to not access their first set of scores. 6. Only the study statistician (Raja) was unblinded to the correspondence between the two set of scores. 7. Statistical analysis was completed by performing weighted kappa statistics on SPSS.
  6. 6. An example of how each suture anchor was graded in the validation study.
  7. 7. RESULTS RATER AGREEMENT BETWEEN FIRST SCORING EXERCISE (%) KAPPA VALUE (95% CI) Rater 1 vs Rater 2 15/31 (48) 0.514 (0.291–0.738) Rater 1 vs Rater 3 16/31 (52) 0.484 (0.230–0.738) Rater 1 vs Rater 4 15/31 (48) 0.494 (0.254–0.733) Rater 1 vs Rater 5 14/31 (45) 0.335 (0.141–0.528) Rater 1 vs Rater 6 17/31 (55) 0.556 (0.353–0.758) Rater 2 vs Rater 3 20/31 (65) 0.603 (0.366–0.840) Rater 2 vs Rater 4 21/31 (68) 0.693 (0.490–0.896) Rater 2 vs Rater 5 16/31 (52) 0.433 (0.240–0.625) Rater 2 vs Rater 6 13/31 (42) 0.463 (0.271–0.655) Rater 3 vs Rater 4 19/31 (61) 0.478 (0.187–0.769) Rater 3 vs Rater 5 16/31 (52) 0.316 (0.091–0.543) Rater 3 vs Rater 6 10/31 (32) 0.300 (0.044–0.556) Rater 4 vs Rater 5 16/31 (52) 0.415 (0.199–0.632) Rater 4 vs Rater 6 13/31 (42) 0.493 (0.312–0.673) Rater 5 vs Rater 6 19/31 (61) 0.389 (0.178–0.600) . Table 1: Interrater agreement of bone response around suture anchors. SS vs SS SS vs MSK MSK vs MSK
  8. 8. RESULTS RATER AGREEMENT BETWEEN FIRST AND SECOND SCORING EXERCISES (%) KAPPA VALUE (95% CI) Rater 1 17/31 (55) 0.597 (0.391–0.804) Rater 4 23/31 (74) 0.790 (0.646–0.934) Rater 5 23/31 (74) 0.663 (0.444–0.882) Rater 6 18/31 (58) 0.5691 (0.332-0.807) . Table 2: Intrarater agreement of bone response around suture anchors. SS MSK
  9. 9. SUMMARY 1. Validation study suggests that the grading system is feasible and easy to use in the clinical setting. 2. Interrater and intrarater reliability of the grading system, on the whole, showed moderate to substantial reliability. 3. Although these results could be further improved through providing raters with a training module beforehand, the next step should be to validate this grading system in other centres.
  10. 10. ACKNOWLEDGEMENTS Professor Lennard Funk Professor Waqar Bhatti Emma Torrence Gulraiz Ahmed Professor Jonathan Harris Andrew Dunn Anand Kirwadi Puneet Monga
  11. 11. THANK YOU

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