Rotator cuff tear

Study shows Smith+Nephew's REGENETEN™ Bioinductive Implant sets new standard of recovery for partial-thickness rotator cuff tears

Retrieved on: 
Wednesday, July 21, 2021

Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.

Key Points: 
  • Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.
  • Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry.
  • Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up.
  • Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up.

Study shows Smith+Nephew's REGENETEN◊ Bioinductive Implant sets new standard of recovery for partial-thickness rotator cuff tears

Retrieved on: 
Wednesday, July 21, 2021

Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.

Key Points: 
  • Smith+Nephew's REGENETEN Bioinductive Implant is available in the US, Europe and other select countries worldwide.
  • Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry.
  • Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up.
  • Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up.

Stryker announces the FDA clearance of the first biodegradable subacromial balloon spacer, filling a gap in the shoulder continuum of care

Retrieved on: 
Tuesday, July 13, 2021

KALAMAZOO, Mich., July 13, 2021 /PRNewswire/ -- Stryker announced today the FDA clearance of the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs)*.

Key Points: 
  • KALAMAZOO, Mich., July 13, 2021 /PRNewswire/ -- Stryker announced today the FDA clearance of the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs)*.
  • InSpace provides a new option for surgeons in their shoulder continuum of care that allows them to better meet the needs of their patients.
  • This ground-breaking technology was acquired from OrthoSpace, Ltd. in 2019 and is the first of its kind in the U.S. market.
  • The InSpace balloon implant is designed to restore the subacromial space without requiring sutures or fixation devices and has been demonstrated to improve shoulder motion and function.

Ortho Regenerative Technologies Announces Submission of Investigational New Drug Application for ORTHO-R

Retrieved on: 
Tuesday, April 6, 2021

Phase I/II clinical trial initiation for rotator cuff tear repair in the U.S. anticipated in Q2 2021

Key Points: 
  • Phase I/II clinical trial initiation for rotator cuff tear repair in the U.S. anticipated in Q2 2021
    MONTRAL, April 6, 2021 /PRNewswire/ - Ortho Regenerative Technologies Inc .
  • "The IND submission for our first ORTHO-R human trial is a key milestone for the Company.
  • About Ortho Regenerative Technologies Inc.
    Ortho RTI is a clinical stage orthobiologics company dedicated to the development of novel therapeutic soft tissue repair technologies to dramatically improve the success rate of orthopedic and sports medicine surgeries.
  • View original content to download multimedia: http://www.prnewswire.com/news-releases/ortho-regenerative-technologies-...
    SOURCE Ortho Regenerative Technologies Inc.

DURECT Corporation Announces U.S. FDA Approval of POSIMIR® For Post-Surgical Pain Reduction for up to 72 Hours Following Arthroscopic Subacromial Decompression

Retrieved on: 
Tuesday, February 2, 2021

"We are excited to announce the approval of POSIMIR, a novel, non-opioid, sustained-release local analgesic for the treatment of post-surgical pain following arthroscopic subacromial decompression surgery," said James E. Brown, President and CEO of DURECT.

Key Points: 
  • "We are excited to announce the approval of POSIMIR, a novel, non-opioid, sustained-release local analgesic for the treatment of post-surgical pain following arthroscopic subacromial decompression surgery," said James E. Brown, President and CEO of DURECT.
  • At the end of surgery, POSIMIR is administered into the subacromial space under direct arthroscopic visualization, where it continuously releases bupivacaine for 72 hours or more.
  • Arthroscopic subacromial decompression is generally considered outpatient surgery, and most patients go home within a few hours of surgery.
  • POSIMIR (bupivacaine solution) for infiltration use is indicated in adults for administration into the subacromial space under direct arthroscopic visualization to produce post-surgical analgesia for up to 72 hours following arthroscopic subacromial decompression.

Shoulder SLAP Tear: Challenging, Sometimes Controversial

Retrieved on: 
Wednesday, January 13, 2021

And researchers, writing in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), indicate a large percentage of patients with confirmed SLAP tears also have co-existing shoulder joint disorders.

Key Points: 
  • And researchers, writing in the Journal of the American Academy of Orthopaedic Surgeons (JAAOS), indicate a large percentage of patients with confirmed SLAP tears also have co-existing shoulder joint disorders.
  • In one study, described in the journal article, 88 percent of patients diagnosed as having SLAP tears had additional shoulder pathologies.
  • Chronic deep shoulder pain or pain felt in the back of the joint during shoulder movements, shoulder weakness, inhibited range of motion, a clicking or popping in the joint, and a sensation that the joint is catching, or locking are all symptoms of a SLAP tear.
  • Engage in exercises designed to stretch, strengthen, and stabilize shoulder joint capsules and shoulder blade muscles.

Delaying Rotator Cuff Surgery for 12 Months or Longer May Double the Odds of Needing Revision Surgery

Retrieved on: 
Monday, October 19, 2020

The revision rate for patients with rotator cuff tears who delayed surgery for 12 months or more was 15.2 percent, versus 9.9 percent for those who had surgery within six weeks and 8.3 percent for those who received surgery within the routine period of six weeks to 12 months of diagnosis.

Key Points: 
  • The revision rate for patients with rotator cuff tears who delayed surgery for 12 months or more was 15.2 percent, versus 9.9 percent for those who had surgery within six weeks and 8.3 percent for those who received surgery within the routine period of six weeks to 12 months of diagnosis.
  • "Our research was designed to investigate the relationship between delaying surgery and the need for subsequent revision due to failure of the initial rotator cuff repair."
  • The rotator cuff is a set of four muscles around the shoulder that keeps the joint centered in order to allow the upper arm to rotate.
  • Rotator cuff tears are common, affecting more than three million people in the United States every year.

'Frozen' Not Just a Popular Movie; It's a Common Shoulder Problem

Retrieved on: 
Friday, July 17, 2020

It's something that can happen to a shoulder joint oftentimes for unknown reasons resulting in stiffness, persistent pain and loss of range of motion.

Key Points: 
  • It's something that can happen to a shoulder joint oftentimes for unknown reasons resulting in stiffness, persistent pain and loss of range of motion.
  • Dr. Badia notes that the disorder is relatively common, but its diagnosis and the most effective methods for "thawing" the affected joint remain challenging.
  • "Unlike frozen shoulder, which can gradually ease on its own, shoulder impingement must be addressed quickly to avoid permanent joint damage," Dr Badia says.
  • In fact, statistics indicate that as many as 10 percent of patients treated for a rotator cuff problem will experience frozen shoulder.

FDA-Approved Randomized Controlled Feasibility Study Finds InGeneron's Regenerative Cell Therapy to Significantly Reduce Pain and Improve Shoulder Function Over Corticosteroid Injection to Address Symptomatic Partial-Thickness Rotator Cuff Tears

Retrieved on: 
Tuesday, April 7, 2020

This prospective multicenter feasibility study performed by Sanford Health is the first randomized controlled trial in which cells isolated from patients own adipose tissue were compared to another therapy option for treating sPTRCT.

Key Points: 
  • This prospective multicenter feasibility study performed by Sanford Health is the first randomized controlled trial in which cells isolated from patients own adipose tissue were compared to another therapy option for treating sPTRCT.
  • Specifically, subacromial injection of corticosteroid was compared to injection of UA-ADRCs isolated from the subjects' own adipose tissue using InGeneron's Transpose RT System.
  • Symptomatic partial-thickness rotator cuff tears (sPTRCT) are among the most common injuries and ailments of the shoulder, especially in elderly patients.
  • Subacromial corticosteroid injection, one of the standard therapies for sPTRCT, often leads to a temporary improvement in clinical symptoms, but not a cure.

New study shows 96% healing of hard to treat large and massive rotator cuff tears with Smith+Nephew's REGENETEN™ Bioinductive Implant

Retrieved on: 
Tuesday, November 19, 2019

No implant-related adverse events occurred.1

Key Points: 
  • No implant-related adverse events occurred.1
    "REGENETEN is the first solution of its kind to treat large and massive thickness rotator cuff tears," said Vasant Padmanabhan, President of R&D, Smith+Nephew.
  • "More than 650,000 rotator cuff procedures take place annually in the US, potentially growing at a rate of 5-6% each year.
  • Evaluation of healing rates and safety with a bioinductive collagen patch for large and massive rotator cuff tears: 2-year safety and clinical outcomes.
  • Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up.