I'll be speaking about subacromial balloon spacer versus partial repair for massive rotator cuff tears, a randomized multicenter trial. Thanks very much. I'd like to start by acknowledging my co-investigators as well as the study team. For any of you who have done multicenter studies, you know it takes a small army to get the job done, and all of the individuals named here deserve credit. So I think we all recognize that massive rotator cuff tears present a dilemma for our surgeons and result in prolonged recovery and inconsistent outcomes for our patients. The InSpace device is a biodegradable subacromial implant. It's designed for rapid and technically easy deployment within the subacromial space. It provides humal head depression, facilitating rehabilitation, and short to midterm outcome studies primarily from Europe have demonstrated consistently good functional outcomes with persistent pain relief, although no comparative studies have been completed. The purpose of this study was to evaluate the safety and efficacy of the InSpace device as a primary surgical treatment for full thickness massive rotator cuff tears. This was a prospective multicenter single-blinded study in patients over the age of 40 with massive tears. We compared InSpace alone to partial repair alone at standardized time frames up to 24 months. We hypothesized that the InSpace device would perform in an equivalent fashion with safety data to support its use. The study design, as you see here, the inclusion and exclusion criteria, the important points are full thickness massive tears amenable to partial repair only in patients who were symptomatic and had failed a conservative course. The exclusion criteria included severe arthritis and subscapularis tears that required repair or were irreparable. Our study methods, we enrolled 93 patients in the InSpace group, 91 patients in the partial repair group. We recorded total operative time, the insertion time for the device, as well as the number of anchors used. Follow-up was standardized up to 24 months. We completed various patient reported outcome measures and our primary outcome variable was the ASES score. The rehabilitation was standardized. All patients were protected in a sling for four weeks to protect blinding and then we followed a relatively consistent partial repair protocol thereafter. The study results at 24 months, there were mean age of 66 years, average time of symptoms was about 33 months, about 90% subject retention rate, which is extremely favorable for a study of this size. You can see the various concomitant procedures that were done in each group with no difference between the groups. We used ASES outcome measures that were relevant to the patient in regards to previously described methodology for MCID, SCB, and PASS scores. We found that for MCID over 80% achieved MCID by 12 months and maintained it up to 24 months. For substantial clinical benefit, again, over 80% achieved it by 12 months and maintained it up to 24 months. And for patient acceptable symptom state, about 50% achieved this by 24 months in both groups. With regard to range of motion, we saw statistically significant improvements in both groups, favoring the in-space group at day 10, week 6, month 12, and month 24. This watershed plot is very helpful. For those who lost motion, they lost more motion in the partial repair group compared to in-space. And for those that gained motion, they gained more motion in the in-space group compared to partial repair. For ROWAC and CONSTANT, again, statistically significant improvements favoring in-space for ROWAC in days 10 and for CONSTANT score at week 6 and month 24. Statistically significant improvements in quality of life and pain scores with no difference between the groups. With regard to the operative time, this significantly favored the in-space group with an average reduction of almost 30 minutes in total operative time. Importantly, there were no device-related adverse events. And with regard to reoperation, two reverse arthroplasties in each group, one revision arthroscopy in each group, and no difference between the groups. There has been previous biomechanical data that supports that both SCR and an in-space implant can normalize humeral head position with no significant differences between the groups, which provides a biomechanical basis on which the clinical results may be achieved. In the literature, there's really only one comparative study that has looked at in-space in combination with or without partial repair. And similar to the results of this study, did show favorable outcomes with regard to ASES score and CONSTANT score favoring the implant, the in-space implant. There are some potential advantages that I think are important. In this study, we had to standardize the rehabilitation protocol, but based on our anecdotal evidence as well as evidence from Europe, we feel that this rehabilitation can be significantly accelerated, which provides an early benefit in regards to return to work and return to activities for our patients, and there may be some easier revision procedures here based on the fact that the implant goes away and there's no instrumentation of the bone. So in summary, the in-space device results in comparable functional and patient-reported outcome measures with earlier recovery for many scores at six weeks in a rapid and technically easy surgical procedure. Thanks very much.

randomized multicenter trial

subacromial balloon spacer

InSpace device

partial repair

massive rotator cuff tears