Partial repair or a balloon implant? Which can deliver better outcomes? A new, two-year multi-center, single blinded, randomized controlled study concluded that a balloon implant, specifically Stryker Corporation’s InSpace Balloon Implant can deliver earlier functional recovery and pain relief and potentially shorter operative time.
The full study; “InSpace Implant Compared with Partial Repair for the Treatment of Full-Thickness Massive Rotator Cuff Tears,” was published in the Journal of Bone and Joint Surgery on April 22, 2022.
Balloon implants were designed to provide a less invasive solution for these patients than other surgical treatment options that require fixation devices or grafts and, in the process, restore the subacromial space.
The two-year multicenter, single-blinded, randomized controlled trial evaluated the efficacy and safety of the implant and found evidence that using the balloon technology can improve shoulder motion and function in patients with irreparable, posterosuperior massive rotator cuff tears compared with partial repair.
“We are excited to see the high-quality data from the U.S. InSpace trial accepted and published by one of the most prestigious orthopaedic journals, lead trial investigator, Nikhil Verma, M.D., said in a press release.
“These results demonstrating InSpace as a safe and effective option with earlier functional recovery, pain relief and shorter operative times are helping us change the game in shoulder surgery and creating better care for patients.”
The study authors enrolled 184 patients, 93 of which were treated using a balloon implant and 91 were treated with arthroscopic partial repair. All the patients had failed nonoperative management.
The primary outcome of the trial was improvement as measured using American Shoulder and Elbow Surgeons scores. The secondary outcomes included change from baseline in the Western Ontario Rotator Cuff score, the Visual Analog Scale pain score, the Constant-Murley shoulder score, the EuroQol-5 Dimensions-5-Level score, active range of motion and operative time.
Overall significant improvements in the American Shoulder and Elbow Surgeons scores were reported in both groups at month 12 and maintained at month 24. Eighty-three percent of the patients in the balloon treated group and 81% of the patients in the partial repair group achieved American Shoulder and Elbow Surgeons minimally clinically important difference threshold, and 82% of the patients in the balloon group and 79% of patients in the partial repair group achieved the substantial clinical benefit threshold.
In addition, forward elevation was greater in the balloon group compared with the partial repair group at Day 10 post-surgery (p = 0.04), Week 6 (p = 0.0001), Month 12 (p = 0.005), and Month 24 (p = 0.003). And the operative time was shorter in the balloon group (p < 0.0001).
The researchers reported 4 reoperations after balloon implantation and 3 after partial repair. There were no device-related surgical complications.
Study authors included Nikhil Verma, M.D., of Rush University Medical Center in Chicago, Uma Srikumaran, M.D., MPH, of Johns Hopkins University School of Medicine in Baltimore, Colleen M. Roden, MSc, of Stryker, Edwin J. Rogusky, M.D., of University Orthopedics Center, State College, Pennsylvania, Peter Lapner, M.D., FRCSC, of the University of Ottawa in Canada, Heather Neil, RN, of OrthoSpace and Joseph A. Abboud, M.D., of The Sidney Kimmel Medical College, Thomas Jefferson University, Rothman Orthopaedic Institute in Philadelphia.
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