InSpace implant demonstrated to be a viable option for patients
with massive irreparable rotator cuff tears.*
KALAMAZOO, Mich., May 3, 2022 /PRNewswire/ -- Stryker (NYSE: SYK)
announced today the publication of results from a multicenter,
single-blinded, randomized controlled trial comparing Stryker's
InSpace implant with partial repair for the treatment of
full-thickness massive irreparable rotator cuff tears (MIRCTs) in
the Journal of Bone and Joint Surgery (JBJS).
The comparative study evaluated the efficacy and safety of
Stryker's InSpace implant with arthroscopic partial repair in
patients with irreparable, posterosuperior MIRCTs.
Results of the two-year study demonstrated the InSpace implant
as an appropriate alternative to partial repair in patients with
MIRCTs. The study also revealed notable patient benefits including
early functional recovery and pain relief combined with a shorter
operative time.
MIRCTs are one of the most common causes of shoulder
dysfunction.1,2,3 The InSpace balloon implant* is a
breakthrough solution in the shoulder continuum of care that
addresses MIRCTs and provides a new, simple surgical treatment
option, allowing surgeons to better meet the needs of their
patients.
"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," said the lead investigator in the clinical
study, Nikhil Verma, M.D. "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."
About the clinical study
The purpose of the Level 1 InSpace pivotal study – a
prospective, single-blinded, multi-center, randomized, controlled
trial was to assess the safety and effectiveness 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 failed
non-operative management, through 24 months of follow-up.
1
Click here to read the full JBJS article on the study.
About the balloon
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 demonstrated to improve shoulder motion and
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 driven to make
healthcare better. The company offers innovative products and
services in Medical and Surgical, Neurotechnology, Orthopaedics and
Spine that help improve patient and healthcare outcomes. Alongside
its customers around the world, Stryker impacts more than 100
million patients annually. More information is available at
www.stryker.com.
Media contact
Kara
Rasmussen
Sr. Director, Communications and PR
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 of a rotator cuff
tear in the general population. J Shoulder Elbow Surg. 2010;
19(1):116-120.
3. Minagawa H, et al. Prevalence of symptomatic and asymptomatic
rotator cuff tears in the general population: From mass-screening
in one village. 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 with partial repair for
treatment of full-thickness massive rotator cuff tears. J Bone
Joint Surg Am. Advance online publication. doi.
10.2106/JBJS.21.00667
*The InSpace™ subacromial tissue spacer system is indicated for
the treatment of patients with massive, irreparable full-thickness
torn rotator cuff tendons due to trauma or degradation with mild to
moderate gleno-humeral osteoarthritis in patients greater than or
equal to 65 years of age whose clinical conditions would benefit
from treatment with a shorter surgical time compared to partial
rotator cuff repair.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/strykers-inspace-subacromial-balloon-spacer-two-year-level-1-randomized-controlled-clinical-study-published-in-the-journal-of-bone-and-joint-surgery-301537815.html
SOURCE Stryker