REGENETEN™ Bioinductive Implant System in Full Thickness Tears - Full Text View - (2023)

  • Repetition rate [terms: 3, 6, 12 and 24 months]

    Cumulative rate of residuals at 3, 6, 12, and 24 months after REGENETEN-enhanced full-thickness ARCR (confirmed by MRI) compared with ARCR alone. Failure is defined as a new tear/recurrence of Sugaya type IV or V (full-thickness discontinuity seen on coronal and oblique sagittal MR images).

  • Oxford Shoulder Score (OSS) [Time period: Baseline, 3, 6, 12, and 24 months]

    The Oxford Shoulder Score (OSS) is a questionnaire to evaluate the results of shoulder surgery that can reduce observer errors in the evaluation. Includes 12-point Pro (Patient Reported Outcome) metrics designed and developed specifically for evaluating shoulder surgery outcomes, such as: B. Assessing the impact of degenerative diseases (eg, arthritis and rotator cuff problems) on the quality of life of patients. The OSS consists of 12 questions, each rated from 0 to 4 (0=excruciating, 1=severe, 2=moderate, 3=mild, 4=none), with 4 being the best score. When all 12 points are added together, total scores ranging from 0 to 48 are obtained, where zero (0) represents a serious shoulder problem and 48 represents no related problem. Higher values ​​represent better clinical results.

  • Western Ontario Rotator Cuff (WORC)/Chinese version WORC (C-WORC) Index) [Time Frame: Baseline, 3, 6, 12, and 24 months]

    The WORC/C-WORC index is self-administered and includes 5 different domains (physical symptoms, sport and leisure, work, social functioning, and emotions). Each question uses a visual analog scale (VAS) that represents a 100-point scale from 0 to 100. The maximum score is 2100 (worst possible symptoms). Zero (0) represents no symptoms at all. The final result can also be presented as a percentage by subtracting the total from 2,100, dividing by 2,100, and multiplying by 100. This will give you an overall percentage. Therefore, overall WORC/CWORC Index scores can range from 0% (lowest level of functional status) to 100% (highest level of functional status).

  • Constant Murley score [timeframe: baseline, 3, 6, 12, and 24 months]

    The Constant Murley score is a validated assessment of shoulder pain and function. The Constant Score is divided into 4 subscales: pain (15 points; VAS score range 0-15), activities of daily living (20 points; range 0=worst, 5=best), strength (25 points; 1 point per 0.5 kg of weights lifted) and range of motion: forward flexion, external rotation, abduction, and internal rotation of the shoulder (40 points; range 0 = worst, 10 = best). The higher the score, the higher the functional quality.

  • Subjective Shoulder Score (SSV) [Time Frame: Baseline, 3, 6, 12, and 24 months]

    Overall performance of REGENETEN-enhanced full-thickness ARCR compared with ARCR alone at baseline and at 3, 6, 12, and 24 months, assessed by subjective shoulder score (SSV). SSV is defined as the subjective assessment of the shoulder by the patient, expressed as the percentage of a completely normal shoulder that would reach 100% (scale from 0% to 100%, being 100% normal).

  • EuroQol 5 dimension 5 level 5 score (EQ-5D-5L) [timeframe: baseline, 3, 6, 12, and 24 months]

    The EQ-5D-5L score consists of two parts: a descriptive system and a visual analogue scale. The descriptive system is used to describe the subject's state of health and consists of five dimensions: mobility, self-sufficiency, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to select the most appropriate response: no problems, slight problems, medium problems, severe problems, and extreme problems. The respondent is asked to indicate her state of health by marking the most accurate statement in each of the five areas.

    The visual analog scale records the subject's self-rated health on a vertical visual analog scale. The scale endpoints are labeled "Best health imaginable" and "Worst health imaginable." The VAS can be used as a quantitative measure of health outcomes assessed by individual respondents.

  • Result of the Patient Satisfaction Questionnaire [Time Frame: Baseline, 3, 6, 12 and 24 months]

    The Patient Satisfaction Questionnaire is a simple subjective assessment of the success of the operation from the patient's point of view. Preoperative: Documented as a visual analog score from 0 to 100. Rated by test person, with 0 being least satisfied and 100 being most satisfied. Postoperative: This includes the VAS patient satisfaction score as for the preoperative and five additional questions the patient is asked: 1. How well did the surgery relieve pain? 2. To what extent has the surgery improved your ability to perform regular activities? 3. How well did the operation allow you to do heavy lifting or exercise (if allowed by the Dr.)? 4. How well did the operation meet your expectations? Questions rated by the patient as excellent, very good, good, fair and poor. 5. Would you repeat the operation in another joint if necessary? Question of the patient evaluated with "quite yes", "probably yes", "possibly not", "not at all" Evaluated by the subject, 0 being the least satisfied, 100 the most satisfied.

  • Pain, Visual Analog Scale (VAS) Score [Time Frame: Baseline, 2 weeks, 6 weeks, 3, and 6 months]

    Overall performance of REGENETEN-enhanced full-thickness ARCR compared with ARCR alone at baseline and at 3, 6, 12, and 24 months, as assessed by VAS pain score. Pain is rated on a 100-point scale ranging from 0 to 100, where zero (0) represents no pain and 100 represents the worst pain imaginable.

  • MRI Tendon Findings in ARCR Supplemented with REGENETEN Compared to ARCR Alone via Sugaya Score Postoperatively [Time Frame: Baseline, 3, 6, 12, and 24 Months]

    The Sugaya score is used to determine the integrity of the postoperative cuff using magnetic resonance imaging, which is divided into 5 categories: Type I to Type V. Type I indicates sufficient thickness with homogeneous low intensity. Type II indicates sufficient thickness with sometimes high intensity. Type III indicates insufficient thickness without discontinuity. Type IV indicates the presence of a minor discontinuity, suggesting a small full-thickness crack. Type V indicates the presence of a major discontinuity, suggesting a medium to large full thickness crack.

  • MRI Tendon Findings in ARCR Supplemented with REGENETEN Versus ARCR Alone via Goutallier Classification Postoperatively [Time Frame: Baseline, 3, 6, 12, and 24 Months]

    The Goutallier classification is used to classify fatty infiltration of the rotator cuff. Goutallier's classification ranges from grade 0, indicating perfectly normal muscle with no marbling, to grade 4, indicating more fat than muscle.

  • Tendon total thickness and tendon length will be assessed postoperatively using MRI tendon findings in ARCR augmented with REGENETEN versus ARCR alone [Time Frame: Baseline, 3, 6, 12, and 24 months ]

    Tendon thickness and length are assessed by MRI

  • Delay size: anteroposterior [AP]/mediolateral [ML]) after operation [time frame: baseline, 3, 6, 12, and 24 months]

    The size of the delay is based on MRI tendon findings with ARCR supplemented with REGENETEN compared with ARCR alone.

  • Form of postoperative delay [time frame: baseline, 3, 6, 12, and 24 months]

    Retarder shape based on MRI tendon findings in ARCR supplemented with REGENETEN versus ARCR alone

  • Return to Work Questionnaire Outcome in ARCR Supplemented with REGENETEN Compared to ARCR Alone [Time Frame: Baseline, 2 Weeks, 6 Weeks, 3, 6, 12, and 24 Months]

    General questionnaire covering work-related questions, including the demographics of blue-collar/sedentary workers.

  • Cumulative duration of opioid use in ARCR supplemented with REGENETEN versus ARCR alone [time frame: 2 weeks]

    Self-reported opioid use diary, completed by the patient daily from days 0 to 14, documenting opioid use. Daily (YES/NO) x 14 days, "Have you taken any opioid medication for your shoulder pain today?" Y/N.

  • Total operative time ARCR supplemented with REGENETEN compared with ARCR alone [Time period: intraoperative time]

    ARCR total operating time was increased with REGENETEN versus ARCR alone.

  • Sling type and mobilization time in ARCR supplemented with REGENETEN versus ARCR alone [time frame: 3 months]

    Sling type is recorded and presented for each treatment arm, summarizing whether a standard sling, shoulder immobilization, abduction sling, ER sling, or other was recommended, and mobilization time is calculated for both arms, summarizing the duration of the mobilization.

  • FAQs

    How long does Regeneten bioinductive implant take to heal? ›

    After treatment with the Regeneten Bioinductive Implant (patch) many patients have far less pain and recover full motion more rapidly. In the majority of cases, they return to full activities of work and daily life as early as four weeks for non-repairs and by 3 to 4 months for repaired tendons.

    Is Regeneten bioinductive implant covered by insurance? ›

    The REGENETEN Bioinductive Implant has been proven to be an effective treatment for rotator cuff tears. Many insurances are now covering the implant, but you will need to check with your insurance to see if prior approval is needed and what their coverage costs are.

    What is Regeneten bioinductive implant? ›

    The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue.

    What is a bioinductive implant for rotator cuff repair? ›

    Bioinductive implant is a revolutionary new procedure for treating patients that have rotator cuff disease. Tendons can heal through the Rotation Medical Bioinductive Implant by introducing new tissue growth. This helps patients perform regular activities much quicker than traditional treatments.

    What are the 3 stages of dental implants? ›

    In general, there are three steps involved in the dental implant procedures. First, the implant itself is placed into the jawbone. Next, the abutment is added to the implant, which is where the artificial tooth will be connected. Finally, the prosthetic tooth, or crown, is placed onto the abutment.

    Will I need time off work after dental implant? ›

    For the average patient, three or four days of rest will suffice after dental implant surgery. Tenderness and some swelling are normal and will subside within the first few days. Many dentists recommend having the implant surgery mid-week, allowing for a day or two off from work plus the weekend to recover.

    What are the complications of Regeneten? ›

    REGENETEN Bioinductive Implant is a relatively safe procedure; however, as with any surgery, some risks and complications may occur, such as the following: Infection. Bleeding. Postoperative pain.

    Is torn rotator cuff surgery worth it? ›

    Surgery may be a good idea if you tore your rotator cuff in a sudden injury and the tear is making your shoulder weak. But surgery can't fully reverse problems that occur over time with wear and tear of the rotator cuff.

    What are the outcomes of Regeneten? ›

    The main outcomes measure was tendon thickness on MRI with Constant and ASES scores as secondary outcomes. At all time points, they showed a significant increase in tendon thickness over published values. Secondarily, Constant and ASES scores also significantly improved from 50.7 to 78.0 and 44.6 to 87.8, respectively.

    Can you fix a rotator cuff tear without surgery? ›

    Rotator cuff tears do not heal on their own without surgery, but many patients can improve functionally and decrease pain with nonsurgical treatment by strengthening their shoulder muscles. Just because there is a tear, does not necessarily mean a surgery is needed.

    Do all full thickness rotator cuff tears require surgery? ›

    Even though most tears cannot heal on their own, you can often achieve good function without surgery. If, however, you are active or use your arm for overhead work or sports, surgery is most often recommended because many tears will not heal without surgery.

    How long does it take to recover from rotator cuff debridement? ›

    During your recovery period, you will work with your physical therapist to regain motion and strengthen the area. The rotator cuff surgery recovery timeline can vary case by case, but a full recovery typically takes four to six months. It may take longer than that to return to heavy lifting.

    What happens if a rotator cuff tear Cannot be repaired? ›

    An untreated rotator cuff tear can eventually cause weakness and disability of the shoulder. That is why it is so important to seek the expertise of an experienced orthopedic doctor for your shoulder pain.

    How long do you wear a brace after rotator cuff surgery? ›

    Patients are often advised to wear a sling or brace for the first 4–6 weeks after rotator cuff repair surgery to prevent them from performing any physical activities involving the affected shoulder (3).

    Is rotator cuff surgery very painful? ›

    Patients who are recovering from rotator cuff surgery know all too well that surgery on the shoulder is often painful. Some patients have very little pain after shoulder surgery, but most have significant pain for a few days to a few weeks.

    How much does it cost for full mouth dental implants? ›

    Full mouth dental implant procedure costs can range anywhere from roughly $7,000 to $68,000 overall. These types of implants have an average cost of around $25,000. Keep in mind that it can cost anywhere from $3,500 to $30,000 to get a top or bottom set of full mouth dental implants.

    How do I prepare for implant surgery? ›

    Important tips every patient needs to know about dental implant surgery
    1. Prepare soft meals. ...
    2. Make proper arrangements. ...
    3. Fast. ...
    4. Secure a ride home. ...
    5. Confirm medications and supplements. ...
    6. Get comfortable. ...
    7. Sleep well. ...
    8. In conclusion, oral hygiene is important.
    Aug 16, 2017

    How painful is dental implant recovery? ›

    You'll Feel Pain And Discomfort For At Least A Week

    For the first few hours after your procedure, you won't feel much. Your mouth will still be numb, and you may still be feeling the effects of dental sedation if you opted to be sedated during your procedure. After these effects wear off, however, some pain is normal.

    How do you sleep after a dental implant? ›

    When it comes to sleeping position following dental surgery, it is a good idea to make sure to elevate the head. A good angle to achieve while sleeping is 45 degrees. You should sleep in the position for the first 36 to 48 hours following the surgery.

    What can you not do after dental implant surgery? ›

    For the first 24 hours after dental implants, be sure to avoid overly hot or cold food and drinks and avoid drinking from a straw. Most importantly, only eat soft foods for the first 24 hours after having the dental implants procedure.

    Do you have to be put to sleep to get a dental implant? ›

    When patients think of dental implants, they automatically think they will be unconscious during surgery. However, Implants actually are only a minor surgery, and do not require complete sedation.

    Can a rotator cuff tear be irreparable? ›

    Irreparable rotator cuff tears are common conditions seen by shoulder surgeons, characterized by a torn and retracted tendon associated with muscle atrophy and impaired mobility. Direct fixation of the torn tendon is not possible due to the retracted tendon and lack of healing potential which result in poor outcome.

    What should I avoid after rotator cuff surgery? ›

    • Do not put weight through your arm or lift anything for six weeks. ...
    • Do not try to reach above or behind you. ...
    • Do not lie on the operated side for a minimum of six weeks. ...
    • Do not get your bandage wet. ...
    • Do not take anti-inflammatory medications such as naproxen for the first twelve weeks. ...
    • Do not soldier on.
    Feb 22, 2021

    Is rotator cuff surgery worse than shoulder replacement? ›

    If your shoulder joint is not damaged at all, rotator cuff surgery is a better option. However, if there is damage to the joint, shoulder replacement is likely the best procedure to go with.

    Do you stay overnight in the hospital after rotator cuff surgery? ›

    – The day of the procedure – Rotator cuff surgery is an outpatient procedure that typically takes a few hours. Generally, it does not require an overnight hospital stay. Once the surgery is complete, your arm will be placed in a sling. You will be kept at the hospital until your pain is well managed with medication.

    How long do you stay in the hospital after torn rotator cuff surgery? ›

    Hospitals typically don't offer same-day shoulder surgery as an option. You will usually have to stay at the hospital for anywhere from 1 to 3 days after your operation so that they can keep an eye on you.

    How do you sleep after rotator cuff surgery? ›

    The best position to sleep in is the one that doesn't put pressure on your affected arm, which means sleeping either on your back or on the unaffected side. You might also be advised to sleep in a reclined position, as it puts less pressure on the injured rotator cuff and promotes healing.

    Is shoulder stronger after rotator cuff surgery? ›

    The greatest improvement in strength consistently occurred during the first 6 months after surgery. Patients also showed marked increases in both work and power. By 12 months after operation mean work had increased to 70% in flexion and abduction and 90% in external rotation of the uninvolved shoulder.

    What is the success rate of supraspinatus surgery? ›

    Rotator cuff surgery has more than a 95% success rate for small tears. For two tendon tears, the success rate is still greater than 70%. Untreated tears tend to get bigger, so it is best to repair tears while they are small. However, even those patients with very large tendon tears may benefit from surgery.

    Is rotator cuff repair a major surgery? ›

    It is well known that rotator cuff surgery is a major operation where the rotator cuff tendons (Figure 1) are sewn back to the upper arm bone (humerus) (Figures 2 and 3). The other major reason patients have pain after rotator cuff surgery is due to stiffness of that shoulder.

    What are 2 warning signs of a rotator cuff tear? ›

    The pain associated with a rotator cuff injury may:
    • Be described as a dull ache deep in the shoulder.
    • Disturb sleep.
    • Make it difficult to comb your hair or reach behind your back.
    • Be accompanied by arm weakness.
    May 18, 2022

    What is the difference between a Type 1 and Type 2 rotator cuff tear? ›

    Grade 0 represents a normal rotator cuff, grade 1 is superficial fraying less than 1 cm in size, grade 2 involves fraying 1 to 2 cm in size, grade 3 is tissue disruption in 2 to 3 cm of tendon, and grade 4 is a substantial cuff tear that involves a sizable flap and more than one tendon.

    What happens if you leave a rotator cuff tear untreated? ›

    If left untreated, a rotator cuff tear can severely restrict function and range of motion. The tear can also increase over time. This may cause partial rotator cuff tears to progress to total tears.

    Can you live with a full rotator cuff tear? ›

    Conclusion: Nonoperative treatment is an effective and lasting option for many patients with a chronic, full-thickness rotator cuff tear. While some clinicians may argue that nonoperative treatment delays inevitable surgical repair, our study shows that patients can do very well over time.

    What percent of rotator cuff tears require surgery? ›

    When does a partial rotator cuff tear need surgery? It is very uncommon to operate on a partial rotator cuff tear. In cases of deep partial tears — when more than 90 percent of the tendon is torn — surgery is recommended only if the symptoms can't be controlled with nonsurgical treatments.

    How often do rotator cuff tears need surgery? ›

    A Word From Verywell. The majority of rotator cuff tears will never require surgery, and many people can find relief with non-surgical treatments. Patients who are told they need rotator cuff surgery should understand the reason for surgery.

    How painful is post op rotator cuff surgery? ›

    Most people who have rotator cuff surgery can expect to feel some level of pain for at least six months after their procedure. In this article, you'll learn about factors that can affect how long you will be in pain after rotator cuff surgery.

    Should you walk after rotator cuff surgery? ›

    Start by walking a little more than you did the day before. Bit by bit, increase the amount you walk. Walking boosts blood flow and helps prevent pneumonia and constipation. Your arm will be in a sling or other device to prevent it from moving for several weeks.

    What is the most painful type of shoulder surgery? ›

    Rotator cuff repair is the most painful surgery in the first postoperative days.

    How serious is a full thickness rotator cuff tear? ›

    Full thickness tearing is characterized by the complete removal of the tendon from the bone. This includes large tears (3–5 cm) and massive tears (>5 cm). In the geriatric population, rotator cuff tears are a prominent clinical problem and many patients report difficulty with routine tasks of daily living.

    What exercises should I avoid with a supraspinatus tear? ›

    People with shoulder injuries should initially refrain from exercises that encourage any movement or movement overhead. Forget about activities like throwing a ball or specific weight training at the gym like overhead presses and pull-ups.

    Can a full thickness tear of the supraspinatus heal? ›

    Only ten (43%) of twenty-three patients over the age of sixty-five years had completely healed tendons (p < 0.001). Conclusions: Arthroscopic repair of an isolated supraspinatus detachment commonly leads to complete tendon healing.

    How soon after rotator cuff surgery can I sleep in bed? ›

    This is really going to depend on your exact surgery and how quickly you recover in general. However, a good rule of thumb is 4-6 months before you can go back to sleeping however you want.

    How long do you have to sleep elevated after rotator cuff surgery? ›

    Sleeping on an incline for 4-6 weeks after surgery is best. For the first week or two, a recliner may be the most comfortable option. Purchasing a 45 degree wedge from a medical supply store can also provide a stable base to prop yourself up in the bed. Wear your sling.

    Is rotator cuff surgery worse than knee surgery? ›

    Summary: Contrary to widespread belief, total surgical replacement of arthritic shoulder joints carries no greater risk of complications than replacement of other major joints, a Johns Hopkins study suggests. Total shoulder replacements are as safe as swapping out hips and knees, according to Hopkins researchers.

    How long does it take for dental implants to completely heal? ›

    In total, it usually takes at least 3-6 months to fully recover from a dental implant, and complete the process. However, this is worth it. Dental implants will last you for the rest of your life if you care for your mouth properly and maintain good oral hygiene.

    How long does it take to heal after dental implant? ›

    After 2 weeks, most patients are fully recovered. The implant site may feel slightly tender to the touch, but should feel completely healed and normal. The implant will continue to heal and bond with the jaw bone over the following 3-6 months, but the initial healing process will be over.

    How long does it take for a bone graft for dental implant to heal? ›

    Though you will probably feel back to normal within a week or two, complete dental bone graft healing can take between three and nine months – sometimes longer. Recovery times depend on several factors, including the type of graft, the area in which the graft was placed and your body's healing capacity.

    How can I make my dental implant heal faster? ›

    Keep any disturbances to your wound to a minimum, to let it heal as fast as possible.
    1. What to expect after surgery. ...
    2. Stick to soft foods. ...
    3. Avoid hot foods and drinks. ...
    4. Don't use a straw. ...
    5. Hydrate and cut alcohol and caffeine. ...
    6. Quit smoking. ...
    7. Limit strenuous activities. ...
    8. Keep the swelling down with ice packs.
    Aug 8, 2018

    Is it painful to get a dental implant? ›

    With numbed nerves, you can expect not to feel any pain during your dental implant procedure. You may feel pressure at times, but it should not cause you discomfort.

    How much does dental implant cost? ›

    First, every case is unique. In general, however, single dental implants cost $1,500 to $2,000 per implant. Not per procedure—but per implant. Some patients are only going to need a single implant, whereas others will need several because they're missing multiple teeth.

    How long does it take for bones to grow around implants? ›

    Typical time for bone integration of a dental implant is 4-6 months, depending on the bone quality. FOLLOW UP APPOINTMENTS: Dr. Farbod will monitor the healing at 1 week, 2 weeks, 1 month and 4-6 months after surgery (times may vary with each individual case).

    What you Cannot do after dental implant? ›

    For the first 24 hours after dental implants, be sure to avoid overly hot or cold food and drinks and avoid drinking from a straw. Most importantly, only eat soft foods for the first 24 hours after having the dental implants procedure.

    What can you not do after an implant? ›

    You'll want to stick to soft foods and avoid hot liquids and spicy items for a few days following oral surgery. After 3-4 days, you should be able to return to a normal diet, but avoid biting on hard items in the area of the implant until it is fully healed.


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