PMS17 BUDGET IMPACT OF NEW RHBMP-2 FORMULATION IN PATIENTS UNDERGOING POSTEROLATERAL SPINAL FUSION PROCEDURES FOR DEGENERATIVE DISC DISEASE IN RANDOMIZED CONTROLLED TRIAL (RCT)

Введение. Чрескожная лазерная декомпрессия межпозвонковых дисков (ЧЛДД) представляет собой современный минимально инвазивный метод хирургического лечения пациентов с дегенеративным заболеванием межпозвонковых дисков. ЦЕЛЬ. Изучить и сравнить клиническую эффективность методик чрескожной лазерной декомпрессии дисков и микродискэктомии у пациентов с дегенеративным заболеванием поясничных межпозвонковых дисков.Методы и материалы. Согласно критериям соответствия, в исследование включены 324 пациента, данные о которых рандомизированы. Среди всех пациентов, включенных в настоящее рандомизированное контролируемое исследование, у 218 респондентов выполнена ЧЛДД поясничного отдела позвоночного столба и у 106 пациентов выполнена поясничная микродискэктомия. Пациенты случайным образом распределены на группы с применением методики блоковой рандомизации в соотношении 2:1.Результаты. Сравнение параметров комбинированной первичной конечной точки исследования продемонстрировало достоверное преимущество клинико-инструментальных показателей в группе пациентов, которым выполнена операция ЧЛДД поясничного отдела позвоночника (р<0,02). Спустя 36-месячный период послеоперационного наблюдения в группе респондентов, которым выполнена процедура ЧЛДД, отмечено достоверное снижение выраженности болевого синдрома в поясничном отделе позвоночного столба на 74 % (с (7,9±1,5) до (2,1±2,5) см), и в группе пациентов, перенесших операцию микродискэктомии, верифицировано снижение выраженности болевого синдрома на 68 % (с (7,9±1,5) до (2,6±3,0) см). Улучшение качества жизни пациентов по Oswestry Disability Index после ЧЛДД и поясничной микродискэктомии было сопоставимо и составило 67 % (с (57±14) до (19±18) %) и 61 % (с (59±14) до (24±20) %) соответственно. Частота встречаемости нежелательных явлений в течение всего периода послеоперационного наблюдения в группе респондентов, которым выполнена ЧЛДД, составила 30 %, а в группе пациентов, перенесших поясничную микродискэтомию, – 43 % (р=0,02). ЗАКЛЮЧЕНИЕ. Исследование наглядно продемонстрировало наличие схожих клинических исходов у пациентов, перенесших ЧЛДД поясничного отдела позвоночника и поясничную микродискэктомию.><0,02). Спустя 36-месячный период послеоперационного наблюдения в группе респондентов, которым выполнена процедура ЧЛДД, отмечено достоверное снижение выраженности болевого синдрома в поясничном отделе позвоночного столба на 74 % (с (7,9±1,5) до (2,1±2,5) см), и в группе пациентов, перенесших операцию микродискэктомии, верифицировано снижение выраженности болевого синдрома на 68 % (с (7,9±1,5) до (2,6±3,0) см). Улучшение качества жизни пациентов по Oswestry Disability Index после ЧЛДД и поясничной микродискэктомии было сопоставимо и составило 67 % (с (57±14) до (19±18) %) и 61 % (с (59±14) до (24±20) %) соответственно. Частота встречаемости нежелательных явлений в течение всего периода послеоперационного наблюдения в группе респондентов, которым выполнена ЧЛДД, составила 30 %, а в группе пациентов, перенесших поясничную микродискэтомию, – 43 % (р=0,02).Заключение. Исследование наглядно продемонстрировало наличие схожих клинических исходов у пациентов, перенесших ЧЛДД поясничного отдела позвоночника и поясничную микродискэктомию.

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Artificial disc replacement versus fusion in patients with cervical degenerative disc disease and radiculopathy: a randomized controlled trial with 5-year outcomes

Journal of Neurosurgery Spine ◽

10.3171/2018.9.spine18659 ◽

2019 ◽

Vol 30 (3) ◽

pp. 323-331 ◽

Cited By ~ 6

Author(s):

Anna MacDowall ◽

Nuno Canto Moreira ◽

Catarina Marques ◽

Martin Skeppholm ◽

Lars Lindhagen ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Outcome Measures ◽

Degenerative Disc Disease ◽

Controlled Trial ◽

Disc Replacement ◽

Artificial Disc ◽

Disc Disease ◽

Fusion Surgery ◽

Randomized Controlled ◽

Artificial Disc Replacement

OBJECTIVEThe method of artificial disc replacement (ADR) has been developed as an alternative treatment to fusion surgery after decompression for cervical degenerative disc disease (DDD) with radiculopathy. Preserving the motion of ADR devices aims to prevent immobilization side effects such as adjacent-segment pathology (ASP). However, long-term follow-up evaluations using MRI are needed to investigate if this intent is achieved.METHODSThe authors performed a randomized controlled trial with 153 patients (mean age 47 years) undergoing surgery for cervical radiculopathy. Eighty-three patients received an ADR and 70 patients underwent fusion surgery. Outcomes after 5 years were assessed using patient-reported outcome measures using the Neck Disability Index (NDI) score as the primary outcome; motion preservation and heterotopic ossification by radiography; ASP by MRI; and secondary surgical procedures.RESULTSScores on the NDI were approximately halved in both groups: the mean score after 5 years was 36 (95% confidence interval [CI] 31–41) in the ADR group and 32 (95% CI 27–38) in the fusion group (p = 0.48). There were no other significant differences between the groups in six other patient-related outcome measures. Fifty-four percent of the patients in the ADR group preserved motion at the operated cervical level and 25% of the ADRs were spontaneously fused. Seventeen ADR patients (21%) and 7 fusion patients (10%) underwent secondary surgery (p = 0.11), with 5 patients in each group due to clinical ASP.CONCLUSIONSIn patients with cervical DDD and radiculopathy decompression as well as ADR, surgery did not result in better clinical or radiological outcomes after 5 years compared with decompression and fusion surgery.Clinical trial registration no.: 44347115 (ISRCTN).

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What is the Role of the Bacterium Propionibacterium acnes in Type 1 Modic Changes? A Review of the Literature

Canadian Association of Radiologists Journal ◽

10.1016/j.carj.2017.07.004 ◽

2017 ◽

Vol 68 (4) ◽

pp. 419-424 ◽

Cited By ~ 10

Author(s):

Mark Georgy ◽

Mark Stern ◽

Kieran Murphy

Keyword(s):

Randomized Controlled Trial ◽

Propionibacterium Acnes ◽

Controlled Trial ◽

Modic Changes ◽

Low Back ◽

Review Of The Literature ◽

Disc Disease ◽

Randomized Controlled

This review presents a summary of the pathology and epidemiology of Modic changes and the possible role of Propionibacterium acnes. This information is followed by a synthesis of the most recent clinical research involved in culturing the discs of patients with degenerative disc disease for the presence of bacteria. We also discuss a randomized controlled trial that investigates the effects of antibiotics on patients with chronic low back pain and type 1 Modic changes. We conclude with a brief discussion of the difficulties involved in this research and the significance of the findings.

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Treatment of Degenerated Intervertebral Discs Using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-site Outcomes With Aggregate and Longer-Term Follow-Up Data

10.21203/rs.3.rs-831525/v2 ◽

2021 ◽

Author(s):

Timothy Davis ◽

Afrida Sara ◽

Terry Nguyen ◽

John Kenneth Burkus

Keyword(s):

Randomized Controlled Trial ◽

Back Pain ◽

Controlled Trial ◽

Single Site ◽

Low Back ◽

Disc Disease ◽

Randomized Controlled ◽

Disc Tissue ◽

Tissue Allograft ◽

Vas Scores

Abstract Background: Disruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. Methods: We assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.Results: At 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.Conclusions: Clinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registration: The trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

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Treatment of Degenerated Intervertebral Discs using a Viable Disc Tissue Allograft for Chronic Discogenic Low Back Pain: A Randomized Controlled Trial Comparing Single-Site Outcomes with Aggregate and Longer-term Follow-Up Data

10.21203/rs.3.rs-831525/v1 ◽

2021 ◽

Author(s):

Timothy Davis ◽

Afrida Sara ◽

Terry Nguyen ◽

John Kenneth Burkus

Keyword(s):

Randomized Controlled Trial ◽

Low Back Pain ◽

Controlled Trial ◽

Single Site ◽

Low Back ◽

Disc Disease ◽

Randomized Controlled ◽

Disc Tissue ◽

Tissue Allograft ◽

Vas Scores

Abstract BackgroundDisruption of the internal structure of the nucleus pulposus commonly occurs with the development of painful degenerative lumbar disc disease. Supplementing disc tissue through autologous or allogeneic human cellular and tissue therapies has been tested in small sample clinical trials. A few investigators have reported substantial improvements in pain and function. A viable disc tissue allograft was developed to supplement tissue loss associated with intervertebral disc degeneration. MethodsWe assessed results in a subgroup of patients from a large trial comparing this allograft with other treatments. A multicenter randomized controlled trial of 218 subjects with chronic low back pain secondary to degenerative disc disease was conducted. Patients were treated with the allograft, saline, or nonsurgical management and studied for 12 months. We assessed longer-term results in a single-site subgroup from this prospective trial.ResultsAt 12 months, subjects from the single-site subgroup who had been randomly assigned to the active allograft group (n=17) showed improvements in both mean Oswestry Disability Index (ODI) and Visual Analog Scale (VAS) scores. There was an overall reduction of 28.69 points in the ODI and 33.06 points in the VAS. This was similar to the aggregate ODI and VAS scores of the active allograft group. At 24 months postprocedure, 9 of the 10 patients remaining in the active allograft group at the single study site had mean ODI and VAS score improvements of 28.23 and 36.13, respectively. A similar improvement in pain scores occurred in the 4 patients at 36 months with mean ODI and VAS score improvements from preoperative scores of 25.21 and 51.35, respectively.ConclusionsClinically meaningful improvements demonstrated in this single-site analysis were comparable to the aggregate study population at 12 months. Longer-term results from this single site at 24 and 36 months suggested durability of viable disc tissue allograft supplementation for patients with discogenic back pain.Trial registrationThe trial was retrospectively registered 17 October 2018 on www.clinicaltrials.gov (NCT03709901) and was approved by the Sterling Institutional Review Board, Atlanta, Georgia (IRB no. 5792).

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