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Clinical outcomes of Bryan cervical disc arthroplasty a prospective, randomized, controlled, single site trial with 48-month follow-up

STUDY DESIGN: Prospective, randomized, controlled. Level 1 evidence. OBJECTIVE: To report functional outcomes at 48 months follow-up on prospectively randomized patients to either the Bryan cervical disc prosthesis or anterior cervical discectomy and fusion (ACDF) at a single site. SUMMARY OF BACKGROUND DATA: Surgical treatment of cervical disc pathology can involve discectomy and fusion (ACDF), the gold standard technique. The safety and effectiveness of this procedure has been established and demonstrated in the literature, however, limitations have evolved and alternatives such as disc replacement are being investigated. Intervertebral disc replacement is designed to preserve motion, both at affected and adjacent levels avoiding limitations of fusion such as adjacent level degeneration. New onset degenerative changes and possible recurring neurologic symptoms may be deferred or eliminated with cervical disc replacement. A recent multicenter trial with 24 months follow-up has shown the Bryan disc to compare favorably with ACDF. Continued follow-up is needed to further evaluate and compare functional outcomes in both these cohorts. METHODS: A total of 47 patients were enrolled at our site as part of an ongoing multicenter prospectively randomized study investigating ACDF versus Bryan cervical disc prosthesis. Functional outcomes are now reported at 48 months follow-up for our cohort of participants. Neck disability index score (NDI), VAS neck and arm and SF-36 both physical and mental as well as complications and reoperations will be reported. RESULTS: Functional outcome data collected at routine follow-up for 48-months has favorably demonstrated improved functional outcomes for NDI, neck/arm pain VAS scores, and the SF-36 physical/mental health component scores for the Bryan arthroplasty and ACDF cohorts. The NDI scores for the Bryan arthroplasty preoperatively was 51 and at 48 months 10. For ACDF preoperative NDI score was also 51 and at 48 months 16.7. At 48 months NDI success, measured by >or=15 points NDI improvement demonstrated a 93.3% success for Bryan arthroplasty and an 82.4% success for ACDF. VAS neck pain scores for the Bryan arthroplasty preoperatively was 76.2 and at 48 months was 13.6. VAS neck pain scores for ACDF preoperatively was 80.6 and at 48 months was 28.1. Arm Pain scores were also measured and for the Bryan arthroplasty preoperatively measured 78.8 and at 48 months 10.8. For ACDF arm pain scores preoperatively measured 77.1 and at 48 months 21.7. These outcomes have not been associated with any degradation of outcome measures from 2 to 4 years. During the 48 months of follow-up at our institution we also report 6 secondary surgeries in our control group (ACDF) and only 1 in our investigational group (Bryan). Of the 6 surgeries in the control group performed, 3 or 12% to date were for adjacent level degenerative disease and 1 or 4% for remote level degenerative disc disease. The remaining 2 surgeries were performed on the same patient for a pseudarthrosis. In the investigational group there was only 1 secondary surgery performed to date for adjacent level disease 5%. CONCLUSIONS: At 48 months, cervical arthroplasty with the Bryan cervical disc prosthesis continues to compare favorably to ACDF at our institution. There has been no degradation of functional outcomes from 24 to 48 months for NDI, VAS of neck and arm, and SF-36. There has been a lower incidence of secondary surgeries for the Bryan arthroplasty cohort to date

Keywords : Adult,Arm,Arthroplasty,Cervical Vertebrae,complications,Disability Evaluation,Female,Follow-Up Studies,Humans,Incidence,Intervertebral Disc,Male,methods,Motion,Neck,Neck Pain,Pain,Pain Measurement,pathology,Patients,Prospective Studies,Pseudarthrosis,Reoperation,Safety,secondary,Spinal Diseases,Spine,surgery,Treatment Outcome,, Outcomes,Bryan,Cervical,Disc, iliolumbar ligament pain

Date of Publication : 2010 Aug

Authors : Garrido BJ;Taha TA;Sasso RC;

Organisation : Department of Orthopaedic Surgery, Indiana Spine Group, Indiana University School of Medicine, Indianapolis, IN, USA

Journal of Publication : J Spinal Disord Tech

Pubmed Link : https://www.ncbi.nlm.nih.gov/pubmed/20087223

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Olivia James
Olivia James
2021-06-23
L4/5 Lumbar decompression and dynamic stabilisation. After 4 years of pain and inability to walk far without sitting down to take pressure off my back and leg, Mr Mo Akmal carried out L4/5 decompression and dynamic stabilisation. The relief from the pain was immediate and I was able to walk up straight at last, pain free. The whole process was really easy and straightforward and I was able to leave the hospital the same day. The difference it has made to my life is amazing. Mr Akmal and his team were professional, friendly and kind at every stage. I have no hesitation in recommending their services.
David Marks
David Marks
2021-06-21
Fantastic medical care I was suffering severe pain in my left leg; diagnosed by my GP as nerve related but no painkillers were having any real effect. Armed with an MRI, I saw Mr Akmal who said immediately that he knew what the problem was an recommended a surgical intervention as a guided cortisone injection would only provide temporary respite. The surgery recommended was the insertion of a small piece of titanium between the two vertebrae that were compressing the nerves going into my leg. I was advised that there were risks, although Mr Akmal's experience was that these risk were minimal. Surgery was arranged for the following week. I visited the hospital the day before the date arranged for surgery to have a number of pre-admission tests and all were fine. I came back the following day at 08:00 and was shown to a glass pod and changed for surgery. A local anaesthetic and sedation were administered and I was unaware of anything until I woke up shortly after the procedure. Within three hours of surgery I was walking, albeit somewhat gingerly and my wife collected me by car at 18:15 that evening to take me home. The nursing staff were very caring and helpful. I had clear instructions of what I needed to do in the two weeks after discharge and then saw Mr Akmal and his colleague 15 days later who inspected the wound from the surgery and said that they were satisfied with how I was healing. I would also mention that I had a phone call at from either Mr Akmal or a colleague to check on how I was doing and inviting me to call if if I was worried about anything every day apart from one for the six days after surgery. More importantly, the relief from the extreme pain was instantaneous. I am walking with a better posture and have had minimal soreness from the procedure. Overall, I would say that my experience was exceptional. I felt well looked after by a team expert in the issue and have immediate and a significant improvement in the quality of my life. There is, as I was told there would be, some residual discomfort from the nerve, which I am sure was in trauma and from the relevant muscles but this improves every day
Martin Williams
Martin Williams
2021-06-03
change your life... I've just completed 3 months with Spine Central and set to continue. after using other Chiro's before I can't tell you how much of a level up this is. My overall health, posture and 'lack of back pain' have really opened me up to a better future. being a Dad of a young 3 year old, I can enjoy the time so much with my Boy. thank you Spine Central.
Lisa P
Lisa P
2021-06-01
Mo Akmal & his team at The Spine unit were absolutely fantastic! My mother walked into the hospital in terrible pain & walked out a few hours later pain free ! She is 87 and now feels like 67 ! The attention she got was excellent I would highly recommend!
Miles McWilliams
Miles McWilliams
2021-05-10
Dr Akmal and his team, I am so happy with A+++ I have known Dr Akmal and his team for the past 8 years, I have seen him and his team ON and OFF for issues regarding my neck, C4/5, C5/6 , C6/7. I first had 3 lots of injections into this area back at the start of things. This helped me for 3 years. Dr Akmal did not want to operate at the time due to my age still been under 40 then. After 3 years I had to see Dr Akmal and his team again. We tried the injection route again but after a few attempts we then had to make the call to cut. I had C5/6 and C6/7 +/- C4/5 anterior cervical decompression and fusion / disc replacement carried out. This was a success and I was out of the hospital within 3 days and recovery took place for the next few months. This year I was operated on the back of my neck for a posterior cervical foraminotomy on the left side at the C5/6 and C6/7 levels. We tried the injections last year but this did not help. Due to Covid to this should have been carried out last year. Dr Akmal explained the risks include nerve injury, dural tear and pain post-operatively but the procedure is fairly routine and the risks are relatively low. Surgery has now taken place back in February. I was released the same day later that evening and been back for my check ups and things are looking up. I am currently training for a half triathlon that I will take part in second week of July. I am doing anything from 120 km to 170 km a week on the bike and running now upto 10 km a day on my running days. I have not been able to swim yet due to pools been closed but I have no issues with movement in me neck. I am very happy I chose Dr Akmal from the start. I did seen two others before him, they were happy to just cut and not look at what was best for me. I also strongly believe the newer technology Dr Akmal uses has really helped me any my life style I lead with sports. I know I would not have had the same results if I did not take the route with Dr Akmal. I really can’t say much more but I am very happy I met Dr Akmal when I did, he has been great and so has his team. Patient Miles McWilliams 😊
Saima Kash
Saima Kash
2021-05-05
Highly recommended!! It was a fantastic experience for my mother in law right from the beginning when she had her first appt with Mr Akmal and was recommended to have a spinal surgery. He has been fantastic, extremely helpful and professional in helping her understand her own condition and pros and cons of the surgery and support her through out the whole process. I would highly recommend him for his excellent professional skills and experience in dealing with patients specially elderly patients.
Radu Ghebaru
Radu Ghebaru
2021-04-23
Professional services - spinal injections Quick and easy to book appointments (online and over the phone). Very helpful receptionist. I had a consultation with dr Akmal who is very professional , patient , kind and understanding. he explained me in details my problem. Trustful and confident in his job, I decided to follow his advice and treatment. I had yesterday a spinal injection . No sides effects so far. A bit in pain but it’s normal. I am aware that I will see the results in one week time only. Great team , exceptional staff (from the receptionist to the nurses and dr Akmal). I would recommend Harley Street Hospital - London Spine Unit to anyone who is having back pains.
Ashraf Elawad
Ashraf Elawad
2021-04-21
Lumbar Disc Surgery. I had difficult times with my disc prolapse in my lower back. The pain was getting worse despite pain killers and physiotherapy. I was a bit nervous considering surgical treatment as a definte solution. The consultation with Mr. Mo Akmal was informative and reassuring and helped me to make a decision going ahead for the surgical option. On the day of the procedure, the staff was welcoming and looked experienced and knew exaclty what they were doing. Mr. Mo Akmal spoke to me before and after the procedure. In less than 2hrs, after the porcedure, I was able to stand, walk, and sit down with no pain. I strongly recommend Mr. Mo Akmal for anybody who has a similar condition.
Joe massimo
Joe massimo
2021-04-16
L5/S1 Microdiscectomy Surgery for 21 year old with Mr Mo Akmal and London spine unit I had minimally invasive spinal surgery for a Bulging disc at L5/S1 impinging on my S1 nerve root. Before surgery I couldn’t walk without a limp and would be in too much pain to walk further than a mile. Being only 21 years old and a keen athlete and student Osteopath, with an interest in sports rehabilitation, I wanted to get back to complete health and fitness from this injury. There is definitely a fear with spinal surgery that a lot of people have in the sports and therapy world however I knew I needed the operation to gain my leg function back and with Mr Mo Akmal and the team at the London spine Unit, I felt in great hands and they were very professional from start to finish with the process. They made me feel very comfortable and safe. I’d highly recommend Mr Mo Akmal and the Team at the London Spine Unit, they are very friendly and take great care of you. I’m feeling much better and am glad I chose to get the surgery done here.
Noam
Noam
2021-04-14
Very good treatment Mr. Akmal Very good treatment from Mr. Akmal and the staff with amazing results. After the first spinal injection I was sure the treatment won't work but as the team encouraged me to keep going to the second injection it then total disappeared. They were also very helpful with all the documents needed for the insurance cover. Much appreciated! I was struggling

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Clinical outcomes of Bryan cervical disc arthroplasty a prospective, randomized, controlled, single site trial with 48-month follow-up | How disc replacement surgery can provide a new lease of life for back

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