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3,876 result(s) for "Decompression - methods"
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Arthroscopic subacromial decompression for subacromial shoulder pain (CSAW): a multicentre, pragmatic, parallel group, placebo-controlled, three-group, randomised surgical trial
Arthroscopic sub-acromial decompression (decompressing the sub-acromial space by removing bone spurs and soft tissue arthroscopically) is a common surgery for subacromial shoulder pain, but its effectiveness is uncertain. We did a study to assess its effectiveness and to investigate the mechanism for surgical decompression. We did a multicentre, randomised, pragmatic, parallel group, placebo-controlled, three-group trial at 32 hospitals in the UK with 51 surgeons. Participants were patients who had subacromial pain for at least 3 months with intact rotator cuff tendons, were eligible for arthroscopic surgery, and had previously completed a non-operative management programme that included exercise therapy and at least one steroid injection. Exclusion criteria included a full-thickness torn rotator cuff. We randomly assigned participants (1:1:1) to arthroscopic subacromial decompression, investigational arthroscopy only, or no treatment (attendance of one reassessment appointment with a specialist shoulder clinician 3 months after study entry, but no intervention). Arthroscopy only was a placebo as the essential surgical element (bone and soft tissue removal) was omitted. We did the randomisation with a computer-generated minimisation system. In the surgical intervention groups, patients were not told which type of surgery they were receiving (to ensure masking). Patients were followed up at 6 months and 1 year after randomisation; surgeons coordinated their waiting lists to schedule surgeries as close as possible to randomisation. The primary outcome was the Oxford Shoulder Score (0 [worst] to 48 [best]) at 6 months, analysed by intention to treat. The sample size calculation was based upon a target difference of 4·5 points (SD 9·0). This trial has been registered at ClinicalTrials.gov, number NCT01623011. Between Sept 14, 2012, and June 16, 2015, we randomly assigned 313 patients to treatment groups (106 to decompression surgery, 103 to arthroscopy only, and 104 to no treatment). 24 [23%], 43 [42%], and 12 [12%] of the decompression, arthroscopy only, and no treatment groups, respectively, did not receive their assigned treatment by 6 months. At 6 months, data for the Oxford Shoulder Score were available for 90 patients assigned to decompression, 94 to arthroscopy, and 90 to no treatment. Mean Oxford Shoulder Score did not differ between the two surgical groups at 6 months (decompression mean 32·7 points [SD 11·6] vs arthroscopy mean 34·2 points [9·2]; mean difference −1·3 points (95% CI −3·9 to 1·3, p=0·3141). Both surgical groups showed a small benefit over no treatment (mean 29·4 points [SD 11·9], mean difference vs decompression 2·8 points [95% CI 0·5–5·2], p=0·0186; mean difference vs arthroscopy 4·2 [1·8–6·6], p=0·0014) but these differences were not clinically important. There were six study-related complications that were all frozen shoulders (in two patients in each group). Surgical groups had better outcomes for shoulder pain and function compared with no treatment but this difference was not clinically important. Additionally, surgical decompression appeared to offer no extra benefit over arthroscopy only. The difference between the surgical groups and no treatment might be the result of, for instance, a placebo effect or postoperative physiotherapy. The findings question the value of this operation for these indications, and this should be communicated to patients during the shared treatment decision-making process. Arthritis Research UK, the National Institute for Health Research Biomedical Research Centre, and the Royal College of Surgeons (England).
Application of intraoperative electrophysiological monitoring in vertebral canal decompression surgery for acute spinal cord injury
Objective This study aimed to evaluate the joint monitoring of somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) in vertebral canal decompression surgery for acute spinal cord injury. Methods Twenty-four patients, who were admitted to the hospital for the surgical treatment of spinal cord injury with SEP and MEP monitoring, were assigned to the intraoperative monitoring group (group I). In addition, 24 patients who were admitted to the hospital for the surgical treatment of spinal cord injury without SEP or MEP monitoring were assigned to the control group (group C). Results In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery. In contrast, there were no significant differences in the P40 latency or amplitude, or the latency of MEP in the AHB, in patients who showed no improvement after surgery. Conclusion In vertebral canal decompression surgery for acute spinal cord injury, the application of joint MEP and SEP monitoring can timely reflect changes in spinal cord function.
Early versus Delayed Decompression for Traumatic Cervical Spinal Cord Injury: Results of the Surgical Timing in Acute Spinal Cord Injury Study (STASCIS)
There is convincing preclinical evidence that early decompression in the setting of spinal cord injury (SCI) improves neurologic outcomes. However, the effect of early surgical decompression in patients with acute SCI remains uncertain. Our objective was to evaluate the relative effectiveness of early (<24 hours after injury) versus late (≥ 24 hours after injury) decompressive surgery after traumatic cervical SCI. We performed a multicenter, international, prospective cohort study (Surgical Timing In Acute Spinal Cord Injury Study: STASCIS) in adults aged 16-80 with cervical SCI. Enrolment occurred between 2002 and 2009 at 6 North American centers. The primary outcome was ordinal change in ASIA Impairment Scale (AIS) grade at 6 months follow-up. Secondary outcomes included assessments of complications rates and mortality. A total of 313 patients with acute cervical SCI were enrolled. Of these, 182 underwent early surgery, at a mean of 14.2(± 5.4) hours, with the remaining 131 having late surgery, at a mean of 48.3(± 29.3) hours. Of the 222 patients with follow-up available at 6 months post injury, 19.8% of patients undergoing early surgery showed a ≥ 2 grade improvement in AIS compared to 8.8% in the late decompression group (OR = 2.57, 95% CI:1.11,5.97). In the multivariate analysis, adjusted for preoperative neurological status and steroid administration, the odds of at least a 2 grade AIS improvement were 2.8 times higher amongst those who underwent early surgery as compared to those who underwent late surgery (OR = 2.83, 95% CI:1.10,7.28). During the 30 day post injury period, there was 1 mortality in both of the surgical groups. Complications occurred in 24.2% of early surgery patients and 30.5% of late surgery patients (p = 0.21). Decompression prior to 24 hours after SCI can be performed safely and is associated with improved neurologic outcome, defined as at least a 2 grade AIS improvement at 6 months follow-up.
Enriched Air Nitrox Breathing Reduces Venous Gas Bubbles after Simulated SCUBA Diving: A Double-Blind Cross-Over Randomized Trial
To test the hypothesis whether enriched air nitrox (EAN) breathing during simulated diving reduces decompression stress when compared to compressed air breathing as assessed by intravascular bubble formation after decompression. Human volunteers underwent a first simulated dive breathing compressed air to include subjects prone to post-decompression venous gas bubbling. Twelve subjects prone to bubbling underwent a double-blind, randomized, cross-over trial including one simulated dive breathing compressed air, and one dive breathing EAN (36% O2) in a hyperbaric chamber, with identical diving profiles (28 msw for 55 minutes). Intravascular bubble formation was assessed after decompression using pulmonary artery pulsed Doppler. Twelve subjects showing high bubble production were included for the cross-over trial, and all completed the experimental protocol. In the randomized protocol, EAN significantly reduced the bubble score at all time points (cumulative bubble scores: 1 [0-3.5] vs. 8 [4.5-10]; P < 0.001). Three decompression incidents, all presenting as cutaneous itching, occurred in the air versus zero in the EAN group (P = 0.217). Weak correlations were observed between bubble scores and age or body mass index, respectively. EAN breathing markedly reduces venous gas bubble emboli after decompression in volunteers selected for susceptibility for intravascular bubble formation. When using similar diving profiles and avoiding oxygen toxicity limits, EAN increases safety of diving as compared to compressed air breathing. ISRCTN 31681480.
Bilateral Spinal Decompression of Lumbar Central Stenosis with the Full-Endoscopic Interlaminar Versus Microsurgical Laminotomy Technique: A Prospective, Randomized, Controlled Study
Background: Extensive decompression with laminectomy, where appropriate, is often still described as the method of choice when operating on degenerative lumbar spinal stenosis. Nonetheless, tissue-sparing procedures are becoming more common. Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation. One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control. This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis. Objective: This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique (FI) with a conventional microsurgical laminotomy technique (MI). Study Design: Prospective, randomized, controlled study. Settings: 135 patients with microsurgical or full-endoscopic decompression were followed up for 2 years. Alongside general and specific parameters, the following measuring instruments were also used for the investigation: Visual Analog Scale (VAS), German version of the North American Spine Society Instrument (NASS), Oswestry Low-Back-Pain-Disability Questionnaire (ODI). Results: Postoperatively 72 % of the patients no longer had leg pain or the pain was almost completely reduced and 21.2 % experienced occasional pain. The clinical results were the same in both groups. The rate of complications and revisions was significantly reduced in the FI Group. The full-endoscopic techniques brought advantages in the following areas: operation, complications, traumatization, rehabilitation. Limitations: Lack of placebo control group. Conclusions: The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled. At the same time, it offers the advantages of a minimally invasive intervention. Key words: Spinal stenosis, central stenosis, spinal decompression, endoscopic spinal decompression, minimally invasive spine surgery
Decompression alone or with fusion for degenerative lumbar spondylolisthesis (Nordsten-DS): five year follow-up of a randomised, multicentre, non-inferiority trial
AbstractObjectiveTo assess whether decompression alone is non-inferior to decompression with instrumented fusion five years after primary surgery in patients with degenerative lumbar spondylolisthesis.DesignFive year follow-up of a randomised, multicentre, non-inferiority trial (Nordsten-DS).Setting16 public orthopaedic and neurosurgical clinics in Norway.ParticipantsPatients aged 18-80 years with symptomatic lumbar spinal stenosis and a spondylolisthesis of 3 mm or more at the stenotic level.InterventionsDecompression surgery alone and decompression with additional instrumented fusion (1:1).Main outcome measuresThe primary outcome was a 30% or more reduction in Oswestry disability index from baseline to five year follow-up. The predefined non-inferiority margin was a −15 percentage point difference in the proportion of patients who met the primary outcome. Secondary outcomes included the mean change in Oswestry disability index, Zurich claudication questionnaire, numeric rating scale for leg and back pain, and EuroQol Group 5-Dimension (EQ-5D-3L) questionnaire.ResultsFrom 12 February 2014 to 18 December 2017, 267 participants were randomly assigned to decompression alone (n=134) and decompression with instrumented fusion (n=133). Of these, 230 (88%) responded to the five year questionnaire: 121 in the decompression group and 109 in the fusion group. Mean age at baseline was 66.2 years (SD 7.6), and 69% were women. In the modified intention-to-treat analysis with multiple imputation of missing data, 84 (63%) of 133 people in the decompression alone group and 81 (63%) of 129 people in the fusion group had a at least a 30% reduction in Oswestry disability index, a difference of 0.4 percentage points. (95% confidence interval (CI) −11.2 to 11.9). The respective results of the per protocol analysis were 65 (65%) of 100 in the decompression alone group and 59 (66%) of 89 in the fusion group, a difference of −1.3 percentage points (95% CI −14.5 to 12.2). Both 95% CIs were higher than the predefined non-inferiority margin of −15%. The mean change in Oswestry disability index from baseline to five years was −17.8 in both groups (mean difference 0.02 (95% CI −3.8 to 3.9)). Results of the other secondary outcomes were in the same direction as the primary outcome. From two to five year follow-up, a new lumbar operation occurred in six (5%) of 123 people in the decompression group and 11 (10%) of 113 people in the fusion group, with a total from baseline to five years of 21 (16%) of 129 people and 23 (18%) of 125, respectively.ConclusionsIn participants with degenerative spondylolisthesis, decompression alone was non-inferior to decompression with instrumented fusion five years after primary surgery. Proportions of subsequent surgeries at the index level or an adjacent lumbar level were no different between the groups.Trial registrationClinicalTrials.gov NCT02051374
Comparison of full-endoscopic and tubular-based microscopic decompression in patients with lumbar spinal stenosis: a randomized controlled trial
PurposeWe aimed to demonstrate non-inferiority in terms of functional outcomes in patients with lumbar spinal stenosis who underwent full-endoscopic decompression compared with tubular-based microscopic decompression. MethodsThis prospective, randomized controlled, non-inferiority trial included 60 patients with single-level lumbar spinal stenosis who required decompression surgery. The patients were randomly assigned in a 1:1 ratio to the full-endoscopic group (FE group) or the tubular-based microscopic group (TM group). Based on intention-to-treat analysis, the primary outcome was the Oswestry Disability Index score at 24 months postoperative. The secondary outcomes included the visual analog scale (VAS) score for back and leg pain, European Quality of Life-5 Dimensions (EQ-5D) score, walking time, and patient satisfaction rate according to the modified MacNab criteria. Surgery-related outcomes were also analyzed.ResultsOf the total patients, 92% (n = 55) completed a 24-month follow-up. The primary outcomes were comparable between the two groups (p = 0.748). However, the FE group showed a statistically significant improvement in the mean VAS score for back pain at day 1 and at 6, 12, and 24 months after surgery (p < 0.05). No significant difference was observed in the VAS score for leg pain, EQ-5D score, or walking time (p > 0.05). Regarding the modified MacNab criteria, 86.7% of patients in the FE group and 83.3% in the TM group had excellent or good results at 24 months after surgery (p = 0.261). Despite the similar results in surgery-related outcomes, including operative time, radiation exposure, revision rate, and complication rate, between the two groups (p > 0.05), less blood loss and shorter length of hospital stay were observed in the FE group (p ≤ 0.001 and 0.011, respectively).ConclusionThis study suggests that full-endoscopic decompression is an alternative treatment for patients with lumbar spinal stenosis because it provides non-inferior clinical efficacy and safety compared with tubular-based microscopic surgery. In addition, it offers advantages in terms of less invasive surgery. Trial registration number (TRN): TCTR20191217001.
Arthroscopic subacromial decompression versus placebo surgery for subacromial pain syndrome: 10 year follow-up of the FIMPACT randomised, placebo surgery controlled trial
AbstractObjectiveTo assess the long term efficacy of arthroscopic subacromial decompression (ASD) versus placebo surgery (diagnostic arthroscopy) and exercise therapy in patients with subacromial pain syndrome.DesignRandomised, placebo surgery controlled trial.SettingOrthopaedic department of three public hospitals in Finland.Participants210 adults aged 35 to 65 years with symptoms consistent with subacromial pain syndrome for more than three months, enrolled from 1 February 2005 with 10 year follow-up to 20 September 2023. Participants and outcome assessors were blinded to group allocation in the primary (ASD versus placebo surgery) comparison.InterventionsASD, placebo surgery, and exercise therapy (1:1:1). Exercise therapy was used as a pragmatic comparator.Main outcome measuresThe primary outcomes were shoulder pain at rest and on arm activity, both assessed at 10 years using a visual analogue scale (VAS, ranging from 0 to 100, with 0 denoting no pain). The minimally important difference was defined as 15. A mixed model repeated measures analysis of variance was used, treating participants as random factors, incorporating baseline values as covariates.ResultsParticipants were randomly assigned to ASD (n=59), placebo surgery (n=63), and exercise therapy (n=71). Of these, a total of 168 participants (87%) completed the 10 year follow-up. In the primary intention-to-treat analysis (ASD versus placebo surgery), no between group differences were observed for the two primary outcomes at 10 years: the mean difference between groups (ASD minus placebo surgery) was −1.5 points (95% confidence interval (CI) −8.6 to 5.6) in VAS pain score at rest and −3.2 points (−13.0 to 6.5) in VAS pain score on arm activity. No significant between group differences were found for any of the secondary outcomes or adverse events. In the pragmatic comparison, the mean difference between groups (ASD minus exercise therapy) was −4.0 points (−11.0 to 3.0) in VAS pain score at rest and −9.4 points (−19.0 to 0.3) in VAS pain score on arm activity. No significant between group differences were observed for the secondary outcomes or adverse events.ConclusionIn patients with subacromial pain syndrome, ASD offered no benefit over placebo surgery or exercise therapy during 10 year follow-up.Trial registrationClinicalTrials.gov NCT00428870.
ISSLS Prize in Clinical Science 2025: A randomized trial on three different minimally invasive decompression techniques for lumbar spinal stenosis. Five years follow-up from the NORDSTEN-SST
Purpose The short-term clinical outcome for midline-preserving posterior decompression techniques was comparable. The aim of this study was to evaluate long-term clinical results after three different midline-preserving posterior decompression techniques. Material In the NORDSTEN spinal stenosis trial (NORDSTEN-SST) 437 patients were randomized to three different midline-retaining posterior decompression techniques: Unilateral laminotomy with crossover (UL), bilateral laminotomy (BL) and spinous process osteotomy (SPO). Primary outcome was the mean change in Oswestry disability index (ODI) score at five-years follow-up. Secondary outcomes were the proportion of patients classified as success, mean change in EQ-5D, ZCQ-score, NRS-score for leg and low back pain, a seven-point Global Perceived Effect (GPE) Scale and proportion of subsequential spinal surgery. Results The number of patients that completed follow-up data after five years was 358 (82%): In the UL, BL and SPO group the numbers were 122, 119 and 117, respectively. Mean age at baseline was 66.7 (SD 8.2) years, mean BMI was 27.8 (SD 4.1), and 172/358 (48%) were female. In the UL group the mean change was  −18.2 (95% CI  −21.0  −5.4), in the BL group it was  −19.0 (95% CI -21.9–16.1) and in the SPO it was  −18.6 (95% CI  −21.6–15.7) (p = 0.917). No significant differences in the secondary outcomes between the three surgical groups were found, also the subsequent spinal surgery rates were similar. Conclusion There were no significant differences in patient reported outcomes and subsequent spinal surgery rates after the three different decompression techniques at five-year follow-up.
Efficacy and safety of multidrug cocktail injections in postoperative pain management for lumbar microendoscopic decompression surgery: a prospective randomized controlled trial
Purpose This study aimed to evaluate the analgesic effects and safety of multidrug cocktail injections for postoperative pain management in patients undergoing lumbar microendoscopic decompression surgery. Methods A prospective randomized controlled trial was conducted with 70 patients who underwent lumbar microendoscopic decompression surgery between December 2023 and May 2024. Patients were randomly assigned to receive either a multidrug cocktail injection (cocktail group, n = 35) or no cocktail injection (non-cocktail group, n = 35). Primary outcomes included scores of the numerical rating scale (NRS) for pain from postoperative days 1 to 7 and the number of analgesics used within the first 3 postoperative days. Secondary outcomes included sex, age, body mass index, preoperative diagnosis, surgical levels, duration of surgery, blood loss, C-reactive protein (CRP) levels on postoperative day 1, and drain output. Results The cocktail group experienced significantly lower pain levels from postoperative days 1 to 7 (p < 0.05) and used fewer analgesics within the first 3 days (p = 0.01) compared with the non-cocktail group. Additionally, the cocktail group had significantly lower CRP levels (p < 0.001) and a shorter hospital stay (p = 0.01). No significant differences were observed in the duration of surgery, blood loss, or drain output between the groups. Conclusion Multidrug cocktail injections are effective and safe for postoperative pain management in lumbar microendoscopic decompression surgery, significantly reducing pain, analgesic use, CRP levels, and hospital stay. These findings suggest that incorporating multidrug cocktail injections into postoperative care protocols can enhance patient recovery and outcomes.