Tier 1 Randomized Controlled Clinical Study of Stryker’s InSpace Subacromial Spacer Published in the Journal of Bone and Joint Surgery

The InSpace implant has proven to be a viable option for patients with massive and irreparable rotator cuff tears.*

KALAMAZOO, Mich., May 3, 2022 /PRNewswire/ — Stryker (NYSE: SYK) today announced the publication of results from a randomized, multi-center, single-blind, controlled trial comparing Stryker’s InSpace Implant to partial repair for the treatment of full-thickness massive irreparable tears of the rotator cuff (MIRCT) in the Journal of Bone and Joint Surgery (JBJS).

The comparative study evaluated the efficacy and safety of the Stryker InSpace implant with arthroscopic partial repair in patients with irreparable posterosuperior MIRCTs.

The results of the two-year study demonstrated that the InSpace implant was an appropriate alternative to partial repair in patients with MIRCT. The study also revealed notable benefits for patients, including early functional recovery and pain relief combined with shorter operative time.

MIRCTs are one of the most common causes of shoulder dysfunction.1,2,3 The InSpace* balloon implant is a revolutionary solution in the shoulder continuum of care that treats MIRCT and offers a new, simple surgical treatment option, allowing surgeons to better meet the needs of their patients.

“We are delighted to see the high-quality data from the US InSpace trial accepted and published by one of the most prestigious orthopedic journals,” said clinical study principal investigator Nikhil Verma, MD. and an effective option with earlier functional recovery, pain relief, and shorter operating times help us change the game in shoulder surgery and create better care for patients.

About the clinical study
The purpose of the InSpace Level 1 Pivotal Study – a prospective, single-blind, multicenter, randomized, controlled trial was to evaluate the safety and efficacy of the InSpace Implant (IS) compared to partial repair ( PR). The study evaluated 184 (n=93 IS; n=91 PR) randomized eligible patients with symptomatic massive full-thickness rotator cuff tears that were not managed nonoperatively, during 24 months of follow-up. . 1

Click here to read the full JBJS article on the study.

About the ball
InSpace is a biodegradable implant designed to restore the subacromial space, providing a less invasive solution compared to other surgical treatment options that require fixation devices or grafts and has been shown to improve movement and shoulder function.4

More information about the InSpace balloon implant is available at www.stryker.com/inspace.

About Stryker
Stryker is one of the world’s leading medical technology companies and, together with its customers, is committed to improving healthcare. The company provides innovative medical and surgical, neurotechnology, orthopedic and spine products and services that help improve patient and healthcare outcomes. Alongside customers around the world, Stryker reaches more than 100 million patients each year. More information is available at www.stryker.com.

Media contact
Kara Rasmussen
Senior Director, Communications and Public Relations
kara.rasmussen@stryker.com
Phone: 408 529 7512

1. Novi M, et al. Irreparable rotator cuff tears: challenges and solutions. Orthop Res Rev. 2018; 10:93-103.
2. Yamamoto A, et al. Prevalence and risk factors for rotator cuff tear in the general population. J Shoulder elbow surgery. 2010; 19(1):116-120.
3. Minagawa H, et al. Prevalence of symptomatic and asymptomatic rotator cuff tears in the general population: Based on village mass screening. J Orthop. 2013; 10(1):8-12.
4. Verma N, Srikumaran U, Roden CM, Rogusky EJ, Lapner P, Neill H, Abboud JA. (2022). InSpace implant compared to a partial repair for the treatment of massive full-thickness rotator cuff tears. J Bone Joint Surg Am. Early online publication. do I. 10.2106/JBJS.21.00667

*The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive, irreparable rupture of the full-thickness rotator cuff tendons due to trauma or degradation associated with Mild to moderate glenohumeral osteoarthritis in patients over 65 years of age. whose clinical conditions would benefit from treatment with a shorter surgical time compared to a partial rotator cuff repair.

SOURCEStryker