Subacromial “Biodegradable Spacer”

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i had keyhole surgery on right shoulder dec.2013 have now had 2nd opp. on same shoulder 10 days ago. this is a trial proccedure, Subacromial “Biodegradable Spacer”.

would like to hear from anyone else who is part of this trial

 

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  • Posted

    Does that mean they cocked it up the first time ???????????????
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    • Posted

      HI,

      No not at all.it started about five years ago, waking up at night after an hours sleep with severe pain in upper arm which would last a couple of hours. over time this got worse and could not get a nights sleep.

      after tests and xrays i had my first opp. this was keyhole and included removel of bone spurs, cleaning joint and decompresstion. 

       A very large tear on the rotery cuff  was found to be is irrepairable

      Post opp i had total rest for three months. the pain at night compleatly stopped. it was another three months before i could return to work. i am a roofing contractor which involves up and down ladders all day and a lot of heavy lifting. if i had a less phyical job i think i would have been fine but because of the rotery cuff tear my shoulder is not stable and the work i do causes the cuff to roll out of the socket . this was now causing pain on the top of my shoulder and to the side of my neck.when working

      The opp i have just had is on trial and is a biodecradable ballon which is inserted above the cuff and under the coller bone. the ballon is inflated with saline.

      been told the idea is this holds the cuff in a stable position allowing a smooth movment of the joint. the implant will dissolve after about 12 months by then all the other muscles around the joint will have time to recover and will then hopefully hold the joint stable. i hope to be back at work within three months.

      The artical below was in the Daily Mail about a week ago

      A small balloon is the latest tool for tackling chronic shoulder pain. The balloon is implanted in the shoulder and then pumped with fluid to the size of a small orange. 

      This then acts as a cushion between the bone and damaged muscle and tendons, preventing further damage and allowing the inflamed tissue to heal. 

      Around one in five Britons develops shoulder pain at some time; the most common cause in the over-40s is a rotator cuff injury. The rotator cuff is the group of muscles and tendons which secures the top of the arm into the shoulder joint. 

      Common rotator cuff injuries include tendonitis - where the tendons become inflamed through being overused or overloaded - and bursitis, where a fluid-filled pad that cushions the tendons becomes irritated and inflamed. 

      A fall or lifting too heavy an item can also cause tears in the muscles or tendons of the cuff. Rotator cuff injuries become more common with age because tendons and muscles weaken. 

      Sportsmen and women involved in activities which require repetitive movements of the shoulders such as rowing and swimming, or people whose jobs require reaching, such as painting and window-cleaning, are particularly at risk. 

      Some conditions including rheumatoid and osteoarthritis can also make injury more likely. Although a rotator cuff injury can be treated with anti-inflammatory medication and physical therapy, in some cases surgery remains the only option. 

      Traditionally, this involves repairing any tears in the muscles or removing worn bone that may be jutting out and causing muscles and tendons to snag on it. However, this carries the risks associated with a general anaesthetic. 

      The new device, on trial at four centres in Italy and Israel, can be implanted as an outpatient under local anaesthetic. The treatment is aimed at increasing the size of the space between the bone and cuff to reduce contact and therefore pain. 

      During the trial, patients had a tiny incision made in the skin using a special hollow implanting tool. When it reached the rotator cuff, a folded and deflated balloon was inserted through the tool and left at the tip. 

      A syringe connected to the other end of the implanting tool was then used to inflate the balloon using saline solution. The procedure takes around ten minutes. 

      Once inflated, the balloon - developed by Israel-based BioProtect - acts as a barrier between the injured tissue and the bone, allowing it to heal. Over time the balloon degrades, although research from pilot studies suggests that the benefits of the extra room in the shoulder remain - so, in theory, preventing the problem happening again. 

      A spokeswoman for Arthritis Research UK, which funds research into rotator cuff injuries, said the device sounded promising. 'We will be interested to see the outcome of the trial, and most importantly whether the beneficial effects are sustained once the balloon degrades.

       more info and pictures and vidios can be found on web page below  (just cut and paste address into browser)

      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3678622/#sec2title

       

       

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  • Posted

    Hi Trevor - thank you so much for the article.  I had a severe rotator cuff injury 17 months ago, and have had keyhole surgery, and decompression of the bone, but unfortunately my two broken tendons could not be reattached.  I was very interested to read about the trial - would you mind telling me where this is being trialled?  I have only heard about a polyester patch before, which is put in place to try to get the tendons to mend themselves.  Regards, Graham
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    • Posted

      Hi,

      not been told much about this trial, my surgeon said he thought it would help me. i think its a random trial, i did read somwhere that it is not yet NICE approved.

      The opp i have been told is totaly reversable as nothing was done to my shoulder other than insert the spacer, which will dissolve and be absorbed by my body in about a years time.

      went back to hospital yesterday for first physio.however i was removed from the group of other shoulder opp patiants. and told that as they had not seen this type of opperation before, they were not sure how to treat me. now awaiting another appointment after thay have consulted my surgeon.

      14 days now shoulder still painfull but not quite as bad, still very little movement, about 10` forward and 5` sideways.

      you may find the following articals helpfull, 

      Dr. Chezar Avi from Emek Medical Center in Afula tells ISRAEL21c he has implanted the device in patients with large unreparable tears causing significant pain, and in older patients seeking to avoid joint replacement surgery. 

      “The biggest advantage is that the procedure is simple, done arthroscopically and the recovery is fast and fairly easy,” reports the surgeon. “Another advantage is that if it fails, you can always return and perform joint replacement surgery in the future.”

       

      Clinical data collected by OrthoSpace shows that approximately 85 percent of patients experience improvement in shoulder function after implantation, and that improvement gets better over time.

       

      Right now, follow-up studies are underway involving 50 Israeli patients as well as recipients of the device at several sites throughout Europe.

       

      Barnea tells ISRAEL21c that the company is expecting to get US Food & Drug Administration approval to initiate a pivotal study in the United States by the end of next year.

       

      “We believe our US pivotal study will show InSpace can be a permanent solution for patients with massive rotator cuff tears,” predicts Barnea. “It will replace more aggressive repair surgeries for patients with the most severe cases, who currently are prone to re-tear rates of 70-80%. We are proposing a less invasive and shorter procedure with shorter rehab, which will provide them with the same pain relief solution [as conventional shoulder surgery].”

       Table 1

      Highlights and Tips for InSpace Use

      Indications

       Torn and irreparable supraspinatus

       Torn and irreparable supraspinatus and torn and reparable infraspinatus

       Torn and irreparable supraspinatus and infraspinatus

       Torn and irreparable supraspinatus, torn and reparable or irreparable infraspinatus, and torn and reparable subscapularis

      Contraindications

       Glenohumeral arthropathy

       Active or latent infection or tissue necrosis

       Allergy to device material (poly-lactide and poly-ε-caprolactone)

       Axillary palsy

      Risks [[low asterisk]]

       Spacer displacement

       Tissue responses to implant, which could include local irritation, infection, and inflammation

      Pitfalls and tips

       The lateral port should be made parallel to the supraglenoid tubercle to enable easy insertion and correct orientation of the device.

       Debridement and bursectomy should be performed to allow proper selection of spacer size and to enable correct positioning to minimize implant displacement risk.

       In cases where the measurement of the distance between the glenoid rim and the lateral border of the acromion falls between 2 spacer sizes (e.g., 49 mm, which is borderline between the small and medium spacer sizes), the larger spacer size should be used (to minimize implant displacement).

       Using a probe through the anterior port could assist in achieving stabilization and proper placement of the device.

       It is highly recommended to follow the manufacturer's instructions regarding inflation volumes and avoid overinflation. To avoid over-tensioning of the deltoid muscle.

       In case of a torn subscapularis, reconstruction is recommended.

       In case of a partially torn long head of the biceps, biceps tenotomy or tenodesis is recommended.

       It is recommended to repair the subscapularis to create anterior/posterior coupling before spacer insertion. If the subscapularis is irreparable, spacer implantation should be considered with caution.[[low asterisk]] The risks mentioned are relatively rare and may occur with every implantable device. If adverse effects occur, they can be treated by routine medications or by arthroscopic puncture and/or removal of the device.

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  • Posted

    Thanks, Trevor, for the information.  Doesn't sound like it's going to be generally available any time soon.
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    • Posted

      Hi,

      if you are still having problems ask your doctor to be refered back to your sergeon and ask him about this opp. i dosnt do any harm to ask.

      good luck, let us know how you get on. will update my post with how i get on

      Trevor

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  • Posted

    Thanks, Trevor!
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  • Posted

    I've just had my left shoulder done (in S.Wales) 5 days ago. Surgeon was quite matter of fact about the technique. I'd had no pain, just inability to do much above shoulder level with the weakness getting progressively worse. No pain post-op so I'll be awaiting seeing what Physios offer. The guy in the ward didn't know what exercise to offer for this. Have any of you had definitive physio experience? I'll let you know how I get on.
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  • Posted

    Hi trevor 70730 and jacqueline01135,

    Hare you coming along now?  (hopefully very well)

    Are you glad, overall,  you had the balloon procedure done?

    Any regrets?

    Can you post the contact information for the doctors who put the spacer in? 

    Thanks very much,

    terry555

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    • Posted

      hi, 

      now been a long time since my opp, What a waste of time. am now in more pain than before my first opp. surgeon tells me now to think about  retiring as thats it . ( im 61 self employed building contractor )

      a lot different to what he told me pre opp.

      ( you will be back at work in a couple our three weeks.)

      very p*ssed off. now stand to lose my house and my busines as i cannot work. if i had know  what i know now i would never had let them touch me. they promise the earth but thay do not have a clue what thay are doing.

      the physio was totaly useless. thay did not know what to do with me.

      i now can use my arm so long as i do not try to lift it above chest hight.

      this implant has left me worse than i was before i had it done. suffuring servere pain at night, and somtimes think it would be best i i did not wake in the morning the surgeon has no interest all and am now tryinyg to raise funds to have mir scan and second oppinion.

      would recomend anyone thinking about this to thing again as it has ruined my life

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  • Posted

    Hi Trevor,

    Sorry to hear that the balloon has not delivered relief.  I think I read that you can have the doctor pierce the balloon so it drains away, so you are then back to square one, I guess.  I wonder if, full of optimism, you may have used your shoulder more after the baloon went in, and perhaps agrivated the joint a bit?  Maybe some benefit will yet come.  I see that the balloon manufacturer encourages the repair of various tendons etc, along with putting in the balloon.  I wonder if the four cuff tendons were fixed as needed during the orginal keyhole?

    terry555

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