Partial Supraspinatus Tendon Tear
A partial supraspinatus tendon tear refers to damage or injury to the supraspinatus tendon, which is one of the four tendons that form the rotator cuff in the shoulder joint. The supraspinatus tendon plays a crucial role in stabilising and facilitating shoulder movement, particularly lifting and rotating the arm.
When a tear occurs in the supraspinatus tendon, it can be classified as either partial-thickness or full-thickness tears. A partial-thickness tear involves damage to only a portion of the tendon, whereas a full-thickness tear goes entirely through the tendon.
Causes of a partial supraspinatus tendon tear can include
- Degeneration: Over time, the tendon can degenerate due to wear and tear, leading to weakening and susceptibility to injury, especially in older individuals.
- Trauma or Injury: A sudden injury or trauma to the shoulder, such as a fall, heavy lifting, or repetitive overhead activities, can result in a tear.
- Overuse: Continuous and repetitive overhead motions, common in certain sports or occupations, can contribute to tendon damage and eventual tears.
The symptoms of a partial supraspinatus tendon tear can vary in severity and might include
- Shoulder Pain: Pain is often felt in the front or side of the shoulder and can worsen when lifting the arm or during specific movements.
- Weakness: Difficulty or weakness when lifting or moving the arm, especially when trying to raise it away from the body.
- Limited Range of Motion: Reduced ability to move the shoulder through its full range of motion.
- Catching or Clicking Sensation: Some individuals might experience a sensation of catching or clicking in the shoulder when moving the arm.
The impact of a partial supraspinatus tendon tear on an individual can range from mild discomfort to significant impairment in shoulder function, depending on the size and location of the tear. It can affect daily activities, work, sports participation, and overall quality of life, particularly if left untreated and leading to further degeneration or full-thickness tears.
It is essential to seek medical evaluation if you suspect a shoulder injury, as early diagnosis and appropriate treatment can prevent further damage and improve outcomes. Treatment options may include rest, physical therapy, corticosteroid injections, or in some cases, surgical intervention, especially if conservative measures do not provide relief. Innovative treatments like the Regeneten Bioinductive Patch aim to offer an alternative for managing such partial tendon tears by promoting natural healing and potentially reducing the need for more invasive surgeries.
Challenges with Traditional Treatment Methods
The limitations and drawbacks associated with conventional approaches used for treating partial supraspinatus tendon tears:
Physical Therapy
- Time-Intensive: Physical therapy often requires a significant time commitment, with multiple sessions per week for an extended period.
- Variable Outcomes: While physical therapy can improve shoulder strength and range of motion, its effectiveness in fully healing a partial supraspinatus tendon tear can vary among individuals.
- Dependence on Compliance: Successful outcomes from physical therapy heavily rely on patient compliance with exercises and rehabilitation protocols. Non-compliance or inconsistency can hinder progress.
Corticosteroid Injections
- Temporary Relief: Corticosteroid injections can provide short-term pain relief by reducing inflammation, but they don’t address the underlying cause or promote tendon healing.
- Potential Side Effects: Repeated injections can lead to weakening of the tendon tissue and, in some cases, increase the risk of tendon rupture. Additionally, side effects such as pain at the injection site, skin discoloration, or infection are possible.
Surgical Repair Methods
- Invasive Nature: Surgical repair involves invasive procedures, which carry inherent risks such as infection, nerve damage, or prolonged recovery times.
- Recovery Period: Recovery after surgery can be lengthy, often requiring immobilisation of the shoulder, followed by a gradual rehabilitation process. It may take months for full recovery and return to normal activities.
- Risk of Re-tear: Despite successful surgery, there’s a risk of re-tear or incomplete healing, especially in cases of larger or more complex tears.
Regeneten Bioinductive Patch
The Regeneten Bioinductive Patch is a medical device specifically designed to aid in the treatment of rotator cuff tendon tears. It is primarily used for partial-thickness tears of the rotator cuff, particularly the supraspinatus tendon.
This patch is made from a unique combination of materials that are bioinductive, meaning they encourage the body’s natural healing processes. The patch is composed of bovine collagen and bioabsorbable polyester that are structured to mimic the natural composition of tendons. It’s engineered to stimulate the body’s own healing response and encourage the regeneration of tendon tissue.
When surgically implanted onto the affected area of the torn tendon, the Regeneten Bioinductive Patch acts as a scaffold. It provides support to the damaged tissue, facilitates the growth of new tendon cells, and encourages the regeneration of healthy tendon tissue. Over time, as the body absorbs the patch, the regenerated tendon tissue ideally becomes stronger and more functional, potentially restoring better shoulder function and reducing pain.
The use of the Regeneten Bioinductive Patch aims to offer an innovative approach to treating rotator cuff tendon tears, particularly partial-thickness tears, with the goal of promoting better healing outcomes and potentially reducing the need for more invasive procedures like traditional tendon repair surgery.
What are the Potential Benefits of Using this Bioinductive Patch?
The use of the Regeneten Bioinductive Patch in the treatment of partial supraspinatus tendon tears offers several potential benefits:
- Stimulates Natural Healing: The patch is designed to mimic the composition of tendons and is bioinductive, meaning it triggers the body’s natural healing response. It encourages the growth of new tendon-like tissue, aiding in the regeneration of damaged or torn tendons.
- Reduced Invasiveness: Compared to traditional surgical repair methods, using the Regeneten Bioinductive Patch might involve a less invasive procedure. This could potentially lead to fewer complications related to surgery, reduced postoperative pain, and a quicker recovery period.
- Improved Healing: The patch provides structural support to the damaged tendon area, potentially promoting more organised and stronger tissue regeneration. This can lead to improved long-term outcomes and a reduced risk of re-tears or incomplete healing compared to some conventional treatments.
- Faster Recovery: Some patients treated with the Regeneten Bioinductive Patch may experience faster recovery times compared to those undergoing more invasive surgical procedures. This can allow individuals to return to their daily activities, work, or sports sooner.
- Potential for Enhanced Functionality: By promoting the regeneration of healthy tendon tissue, the patch may help restore better shoulder function, including improved range of motion and strength, leading to better overall shoulder performance.
- Minimised Risks: The use of the patch might potentially reduce the risks associated with more invasive surgical interventions, such as infection, nerve damage, or complications related to anaesthesia.
- Potential to Avoid or Delay More Invasive Procedures: For some patients, using the Regeneten Bioinductive Patch might serve as an alternative or delay the need for more invasive surgical procedures, providing a less aggressive treatment option initially.
- Clinical Efficacy: Clinical studies and research have shown promising results in terms of pain reduction, improved function, and tissue healing when using the Regeneten Bioinductive Patch for the treatment of partial supraspinatus tendon tears.
How long does it take for the Bioinductive Patch to work?
The effectiveness and timeline for the Regeneten Bioinductive Patch to work can vary among individuals and depend on several factors, including the extent of the tendon tear, the patient’s overall health, adherence to post-operative care, and rehabilitation protocols.
Typically, the Regeneten Bioinductive Patch is designed to initiate a healing response within the body shortly after implantation. However, the complete healing process can take several months.
Patients might start to notice improvements in symptoms such as reduced pain and improved shoulder function within the first few weeks to months after the procedure. However, it’s essential to follow the prescribed rehabilitation program, which may involve physical therapy and specific exercises to gradually strengthen the shoulder and optimise the healing process.
The regenerated tissue continues to mature and strengthen over time. Generally, it might take several months—up to 6 months or more—for patients to experience significant improvements in shoulder function and for the treated area to fully heal.
It is crucial for patients to maintain regular follow-ups with their healthcare provider, adhere to the recommended rehabilitation protocols, and communicate any concerns or changes in symptoms during the recovery period to ensure the best possible outcome.
The Procedure
The process of using the Regeneten Bioinductive Patch for treating partial supraspinatus tendon tears typically involves a surgical procedure, followed by a specific post-operative care plan:
Surgical Technique
- Patient Preparation: The patient is positioned for surgery, often under general anaesthesia or regional anaesthesia.
- Arthroscopic Examination: The surgeon may use an arthroscope (a small camera) inserted through small incisions around the shoulder joint to examine the extent of the tendon tear and identify any associated shoulder joint issues.
- Tendon Preparation: The torn or damaged portion of the supraspinatus tendon is carefully trimmed and prepared to create a suitable environment for the Regeneten Bioinductive Patch application. The goal is to promote tissue healing and regeneration.
- Patch Placement: The Regeneten Bioinductive Patch is surgically implanted onto the prepared area of the tendon tear. The patch serves as a scaffold to support tissue regeneration and stimulate the body’s natural healing process.
- Securement: The patch is secured in place using sutures or other fixation methods to ensure proper placement and contact with the damaged tendon.
- Closure: Once the patch is positioned, the incisions are closed with stitches or surgical tape, and a sterile dressing may be applied to the surgical site.
Post-Operative Care
- Immobilisation: Initially, the shoulder might be immobilised using a sling or brace to protect the repair site. The duration and type of immobilisation can vary based on the surgeon’s recommendation.
- Physical Therapy and Rehabilitation: Following surgery, a structured rehabilitation program supervised by a physical therapist is usually initiated. This program involves specific exercises aimed at gradually increasing shoulder range of motion, strengthening the muscles around the shoulder, and promoting healing of the repaired tendon. The timing and intensity of exercises will be gradually increased based on the patient’s progress.
- Activity Restrictions: Patients are often advised to avoid certain activities, especially those that involve overhead movements or heavy lifting, for a specified period to protect the healing tendon.
- Follow-Up Visits: Regular follow-up visits with the surgeon are essential to monitor healing progress, assess shoulder function, and make any necessary adjustments to the rehabilitation plan.
- Pain Management: Pain management strategies, including medications and modalities such as ice application, may be prescribed to manage post-operative discomfort.
What Are the Evidences to Support the Use of this Bioinductive Patch?
- Bushnell BD, et al. Treatment of partial-thickness rotator cuff tear repairs with a resorbable bioinductive bovine collagen implant: 1-year results from a prospective multi-center registry. Presented at: AOSSM-AANA Combined 2021 Annual Meeting, July 7-11, Nashville, Tennessee.
- Bokor DJ, Sonnabend D, Deady L, et al. Evidence of healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a collagen implant: a 2-year MRI follow-up. Muscles, Ligaments Tendons J. 2016;6(1):16-25.
- Schlegel TF, Abrams JS, Bushnell BD, Brock JL, Ho CP. Radiologic and clinical evaluation of a bioabsorbable collagen implant to treat partial-thickness tears: a prospective multicenter study. J Shoulder Elbow Surg. 2018 27(2):242-251.
- Van Kampen C, Arnoczky S, Parks P, et al. Tissue-engineered augmentation of a rotator cuff tendon using a reconstituted collagen scaffold: a histological evaluation in sheep. Muscles Ligaments Tendons J. 2013;3(3):229-235.
- Bokor DJ, Sonnabend DH, Deady L, et al. Healing of partial-thickness rotator cuff tears following arthroscopic augmentation with a highly porous collagen implant: a 5-year clinical and MRI follow-up. Muscles, Ligaments Tendons J. 2019;9(3):338-347.
- McElvany MD, McGoldrick E, Gee AO, Neradilek MB, Matsen FA, 3rd. Rotator cuff repair: published evidence on factors associated with repair integrity and clinical outcome. Am J Sports Med. 2015;43(2):491-500.
- Arnoczky SP, Bishai SK, Schofield B, et al. Histologic Evaluation of Biopsy Specimens Obtained After Rotator Cuff Repair Augmented With a Highly Porous Collagen Implant. Arthroscopy. 2017;33(2):278-283
In Layman’s Language:
The presented study at the AOSSM-AANA Combined 2021 Annual Meeting compared two treatment approaches for partial-thickness rotator cuff tears: using a REGENETEN Implant alone (without surgical repair) versus using a REGENETEN Implant in addition to traditional surgical repair. The study involved 227 patients from 19 surgical centres across the United States.
Key findings from the study included:
- Improved Shoulder Function with REGENETEN Implant Alone:
Patients who received only the REGENETEN Implant (without surgical repair) reported a significant improvement in shoulder function during the early post-operative period (specifically at weeks 2 and 6) compared to those who underwent traditional surgical repair.
- Equivalent Efficacy at 1 Year:
The study revealed that treatment with the REGENETEN Implant alone showed equivalent effectiveness to using the REGENETEN Implant along with traditional surgical repair. Both groups displayed similar efficacy with minimal revisions across both treatment approaches at the one-year mark.
- Significant Improvements in Pain, Function, and Quality of Life at 1 Year:
Among all patients who received the REGENETEN Implant (regardless of treatment group), there were significant reported improvements in pain levels, shoulder function, and overall quality of life at the one-year follow-up when compared to pre-surgery values. This suggests that the use of the REGENETEN Implant contributed to positive outcomes in terms of pain relief and functional improvement.
These findings suggest that using the REGENETEN Implant alone, without traditional surgical repair, provided notable early improvements in shoulder function compared to traditional repair methods. Moreover, the implant alone showed comparable effectiveness to using the implant alongside traditional surgical repair, with both approaches demonstrating positive outcomes and minimal revisions at the one-year follow-up. Additionally, all patients who received the REGENETEN Implant experienced significant improvements in pain, function, and quality of life at the one-year mark compared to their pre-surgery status.
Case Example:
A 46-year-old man presented with increasing pain in his left shoulder. Examination showed positive subacromial impingement signs. MRI showed a 0.8 x 0.3 cm subacromial spur and distal supraspinatus tendinosis and intrasubstance tear (0.8 x 0.6 cm) at the insertion without footprint retraction.
He failed 9 months of conservative treatment including a cortisone injection to the subacromial space as well as physiotherapy.
He underwent left shoulder arthroscopic subacromial decompression (removal of the bone spur) and implantation of the bioinductive patch to encourage tendon healing.
During the keyhole surgery, there is a large subacromial bone spur.
A burr was used to remove this bone spur.
This is after the acromial bone spur had been removed.
The bioinductive patch was applied over the supraspinatus tendon and secured to the tendon and bone.
This is how it looks like at the end.
