scholarly journals Autologous Matrix-Induced Chondrogenesis (AMIC) and AMIC Enhanced by Autologous Concentrated Bone Marrow Aspirate (BMAC) Allow for Stable Clinical and Functional Improvements at up to 9 Years Follow-Up: Results from a Randomized Controlled Study

2019 ◽  
Vol 8 (3) ◽  
pp. 392 ◽  
Author(s):  
Laura de Girolamo ◽  
Herbert Schönhuber ◽  
Marco Viganò ◽  
Corrado Bait ◽  
Alessandro Quaglia ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Bone Marrow Aspirate ◽  
Controlled Trial ◽  
Activity Level ◽  
Controlled Study ◽  
Level Of Evidence ◽  
Chondral Lesions ◽  
Randomized Controlled ◽  
Functional Scores

The aims of the study were to evaluate long-term outcomes after autologous matrix-induced chondrogenesis (AMIC) in the treatment of focal chondral lesions and to assess the possible improvements given by the combination of this technique with bone marrow aspirate concentrate (BMAC). Twenty-four patients (age range 18–55 years) affected by focal knee chondral lesions were treated with standard AMIC or AMIC enhanced by BMAC (AMIC+). Pain (Visual Analogue Scale (VAS)) and functional scores (Lysholm, International Knee Documentation Committee (IKDC), Tegner, Knee injury and Osteoarthritis Outcome Score (KOOS)) were collected pre-operatively and then at 6, 12, 24, 60, and 100 months after treatment. Magnetic resonance imaging (MRI) evaluation was performed pre-operatively and at 6, 12, and 24 months follow-ups. Patients treated with AMIC+ showed higher Lysholm scores (p = 0.015) and lower VAS (p = 0.011) in comparison with patients in the standard AMIC group at the 12 months follow-up. Both treatments allowed for functional and pain improvements with respect to pre-operative levels lasting up to 100 months. MRI revealed consistent cartilage repair at 24 months in both groups. This study shows that AMIC and AMIC+ are effective treatments for focal chondral lesions with beneficial effect lasting up to 9 years. AMIC+ allows for faster recovery from injury, and is thus more indicated for patients requiring a prompt return to activity. Level of evidence: II, randomized controlled trial in an explorative cohort.

scholarly journals Transconjunctival versus Transcutaneous Injection of Botulinum Toxin into the Lacrimal Gland to Reduce Lacrimal Production: A Randomized Controlled Trial

Toxins ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 77
Author(s):  
Andrew G. Lee ◽  
Shin-Hyo Lee ◽  
Minsu Jang ◽  
Sang Jae Lee ◽  
Hyun Jin Shin
Keyword(s):  
Botulinum Toxin ◽  
Lacrimal Gland ◽  
Botulinum Toxin A ◽  
Controlled Trial ◽  
Clinical Effectiveness ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Delivery Routes ◽  
Tear Meniscus Height

The purpose of this study was to determine and compare the effects between injecting botulinum toxin A (BTX-A) transconjunctivally into the palpebral lobe and transcutaneously into the orbital lobe of the lacrimal gland in patients with epiphora due to lacrimal outflow obstruction. This randomized controlled study included 53 eyes of 31 patients with unilateral or bilateral epiphora. Patients were randomly allocated to receive an injection of BTX-A (3 units) either transconjunctivally (n = 15, 25 eyes) or transcutaneously (n = 16, 28 eyes). For objective assessments, the tear meniscus height and Schirmer’s I test with topical anesthesia were measured at baseline and after 2, 6, 12, and 24 weeks of follow-up. Subjective evaluations were performed using the Munk score. After BTX-A injection, patients in both groups experienced significant objective and subjective reductions in tearing at all follow-up times compared to pre-injection (success rate 86.8%), and the effect lasted for a mean duration of 5.63 months. The two delivery routes showed similar clinical effectiveness for a single injected dose of BTX-A. In conclusion, injecting BTX-A via either a transconjunctival or transcutaneous route helps to reduce normal tear production and results in significant improvements in the symptoms in patients with epiphora.

scholarly journals Results Are Similar Two Years After Acute or Delayed Anterior Cruciate Ligament Reconstruction. A Randomized Controlled Trial

2017 ◽  
Vol 5 (5_suppl5) ◽  
pp. 2325967117S0017
Author(s):  
Karl Eriksson ◽  
Christoffer von Essen ◽  
Björn Barenius
Keyword(s):  
Randomized Controlled Trial ◽  
Primary Endpoint ◽  
Pivot Shift ◽  
Controlled Trial ◽  
Acl Injury ◽  
Activity Level ◽  
Randomized Controlled ◽  
Delayed Group ◽  
The Mean

Objectives: Acute ACLR has been avoided since the 1990’s due to reports of postoperative stiffness. But are these risks still valid with modern arthroscopic techniques? The aim of this randomized controlled trial was to assess the impact of the time between injury and reconstruction on the outcome after ACLR. Our hypothesis was that acute ACLR with semitendinosus graft can be performed safely. Methods: The primary endpoint was ROM at three months after surgery. A power calculation revealed the need for 64 patients to detect a ROM difference of 5 degrees between the groups (5% significance level). 70 patients with a high recreational activity level (Tegner ≥6) who presented with an acute ACL injury were randomized to an acute reconstruction within 8 days from the injury or delayed reconstruction (after normalized ROM) 6-10 weeks after the injury. Fixation was with Endobutton in femur and a metallic interference screw in tibia. The rehabilitation was performed at the same physiotherapy center for all patients. Follow up assessment was performed by a physiotherapist not involved with the rehabilitation. The follow up at 24 months included ROM, Lachman, instrumented laxity with Rolimeter, pivot shift, one leg hop index, Biodex, IKDC, KOOS, Lysholm and Tegner Activity level, and a VAS question regarding knee function and the knee function’s effect on activity level. Results: Seventy percent of the patients were males, mean age at the time of surgery was 27 years (18 -41) and the median pre-injury Tegner level was 9 (6-10) with no differences between the groups. 64 (91%) patients were assessed at three months with no difference according to the primary endpoint. Median Tegner level was restored to pre-injury levels in both groups after one year, and did not change between one and two years. 63 (90%) patients were available for the 2-year follow up. There was one graft rupture and one contralateral ACL injury in both groups. There was additional surgery in 15% of the acute patients and in 31% in the delayed (n.s.). The mean instrumented laxity was 1.8 mm in the acute and 2.0 in the delayed group. There were no positive pivot shift in the acute group and 6 patients with grade 1 or not possible to perform in the delayed group (p=0.039). IKDC revealed no significant differences between the groups. Lysholm score was 87 in both groups. KOOS values showed no significant difference between the groups. VAS response to the question “How is your knee working on a scale from 0-100? (100 = best)” was 81 in the acute and 71 in the delayed group (p=0.1) and “How does your knee affect your activity level? (100 = no affection)” the mean score was 75 in the acute and 67 in the delayed group (p=0.3). Functional strength (one leg hop index >90%) was 85% in the acute and 67% in the delayed group (n.s). Conclusion: We found no increased risk of arthrofibrosis after acute ACLR. Good results can be achieved at two years regardless of ROM and swelling in the acute stage.

scholarly journals An Integrative Neuro-Psychotherapy Treatment to Foster the Adjustment in Acquired Brain Injury Patients—A Randomized Controlled Study

2020 ◽  
Vol 9 (6) ◽  
pp. 1684
Author(s):  
Antoine Urech ◽  
Tobias Krieger ◽  
Eveline Frischknecht ◽  
Franziska Stalder-Lüthy ◽  
Martin grosse Holtforth ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Brain Injury ◽  
Brain Injuries ◽  
Controlled Trial ◽  
Acquired Brain Injury ◽  
Post Treatment ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Treatment Standard

Adjustment disorders (AjD) with depressive symptoms following an acquired brain injury (ABI) is a common phenomenon. Although brain injuries are increasing more and more, research on psychological therapies is comparably scarce. The present study compared, by means of a randomized controlled trial (RCT), a newly developed integrative treatment (Standard PLUS) to a standard neuropsychological treatment (Standard). Primary outcomes were depressive symptoms assessed with the Beck Depression Inventory (BDI-II) at post-treatment and 6-month follow-up assessment. In total, 25 patients (80% after a stroke) were randomized to one of the two conditions. Intention-to-treat analyses showed that the two groups did not significantly differ either at post-treatment nor at follow-up assessment regarding depressive symptoms. Both treatments showed large within-group effect sizes on depressive symptoms. Regarding secondary outcomes, patients in the Standard PLUS condition reported more emotion regulation skills at post-assessment than in the control condition. However, this difference was not present anymore at follow-up assessment. Both treatments showed medium to large within-group effects sizes on most measures for patients suffering from an AjD after ABI. More research with larger samples is needed to investigate who profits from which intervention.

How Does the Presence of Unstable Chondral Lesions Affect Patient Outcomes After Partial Meniscectomy? The ChAMP Randomized Controlled Trial

2017 ◽  
Vol 46 (3) ◽  
pp. 590-597 ◽  
Author(s):  
Leslie J. Bisson ◽  
Melissa A. Kluczynski ◽  
William M. Wind ◽  
Marc S. Fineberg ◽  
Geoffrey A. Bernas ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Injury ◽  
Short Form ◽  
Controlled Trial ◽  
Partial Meniscectomy ◽  
Postoperative Outcomes ◽  
Level Of Evidence ◽  
Chondral Lesions ◽  
Randomized Controlled ◽  
Outcome Score

Background: Chondral lesions are commonly encountered during arthroscopic partial meniscectomy (APM); however, it is unknown how these lesions affect postoperative outcomes. Purpose: The authors compared postoperative outcomes among patients with and without unstable chondral lesions 1 year after APM. Study Design: Cohort study; Level of evidence, 3. Methods: The authors conducted a secondary analysis of data from the ChAMP (Chondral Lesions and Meniscus Procedures) randomized controlled trial. They compared the following outcomes for patients with unstable chondral lesions that were left in situ and observed (CL-noDeb) versus patients without unstable chondral lesions (NoCL) at 1 year after APM: Western Ontario and McMaster Universities Osteoarthritis Index, Knee injury and Osteoarthritis Outcome Score, visual analog scale for pain, the Short Form Health Survey, range of motion, quadriceps circumference, and effusion. Multivariate linear regression was used to obtain mean differences (MDs) with corresponding 95% CIs adjusted for age, body mass index, and preoperative score (for postoperative scores). Results: Compared with the CL-noDeb group, the NoCL group had greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index for pain (MD, 7.9, 95% CI: 2.7-13.1), stiffness (MD, 9.1, 95% CI: 1.9-16.3), and physical function (MD, 4.6, 95% CI: 0.1-9.0) and Knee injury and Osteoarthritis Outcome Score for pain (MD, 8.4, 95% CI: 2.7-14.0), function in sport and recreation (MD, 11, 95% CI: 3.0-19.1), and quality of life (MD, 10.4, 95% CI: 2.3-18.5). The NoCL group was less likely than the CL-noDeb group to have an effusion ( P = .02) 1 year after surgery. Conclusion: Patients undergoing APM without unstable chondral lesions had better outcomes than patients with unstable chondral lesions.

scholarly journals Percutaneous Epidural Adhesiolysis Using Inflatable Balloon Catheter and Balloon-less Catheter in Central Lumbar Spinal Stenosis with Neurogenic Claudication: A Randomized Controlled Trial

2018 ◽  
Vol 1 (21;1) ◽  
pp. 593-605
Author(s):  
Seong-Soo Choi
Keyword(s):  
Spinal Stenosis ◽  
Lumbar Spinal Stenosis ◽  
Controlled Trial ◽  
Balloon Catheter ◽  
Controlled Study ◽  
Neurogenic Claudication ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Lumbar Spinal

Background: When conventional interventional procedures fail, percutaneous epidural adhesiolysis (PEA), which has moderate evidence for successful treatment of lumbar spinal stenosis (LSS), has been recommended over surgical treatments. In a previous study, we demonstrated the efficacy of a newly developed inflatable balloon catheter for overcoming the access limitations of pre-existing catheters for patients with severe stenosis or adhesions. Objectives: This study compared the treatment response of combined PEA with balloon decompression and PEA only in patients with central LSS over 6 months of follow-up. Study Design: This study used a randomized, single-blinded, active-controlled trial design. Setting: This study took place in a single-center, academic, outpatient interventional pain management clinic. Methods: This randomized controlled study included 60 patients with refractory central LSS who suffered from chronic lower back pain and/or lumbar radicular pain. Patients failed to maintain improvement for > 1 month with epidural steroid injection or PEA using a balloon-less catheter. Patients were randomly assigned to one of 2 interventions: balloon-less (n = 30) and inflatable balloon catheter (n = 30). The Numeric Rating Scale (NRS-11), Oswestry Disability Index (ODI), Global Perceived Effect of Satisfaction (GPES), and Medication Quantification Scale III were each measured at 1, 3, and 6 months after PEA. Results: There was a significant difference between groups in NRS-11 reduction ≥ 50% (or 4 points), ODI reduction ≥ 30% (or 10 points), GPES ≥ 6 and ≥ 4 points at 6 months, and NRS11 reduction ≥ 50% (or 4 points) at 3 months after PEA (P < .03). The proportion of successful responders was higher in the balloon group than in the balloon-less group throughout the total follow-up period. Furthermore, there was a statistically significant difference between groups at 6 months after PEA (P = .035). Limitations: The results may vary according to the definition of successful response. Follow-up loss in the present study seemed to be high. Conclusion: PEA using the inflatable balloon catheter leads to significant pain reduction and functional improvement compared to PEA using the balloon-less catheter in patients with central LSS. The study protocol was approved by our institutional review board (2012-0235), and written informed consent was obtained from all patients. The trial was registered with the Clinical Research Information Service (KCT 0002093). Key words: Balloon decompression, central, chronic pain, epidural adhesiolysis, lumbar, percutaneous, radiculopathy, spinal stenosis

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