scholarly journals Combined ACL and Anterolateral Reconstruction Is Not Associated With a Higher Risk of Adverse Outcomes: Preliminary Results From the SANTI Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712091849 ◽  
Author(s):  
Bertrand Sonnery-Cottet ◽  
Charles Pioger ◽  
Thais Dutra Vieira ◽  
Florent Franck ◽  
Charles Kajetanek ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Range Of Motion ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Adverse Outcomes ◽  
Randomized Controlled ◽  
Increased Risk ◽  
Significant Difference

Background: The widespread historical abandonment of lateral extra-articular procedures in anterior cruciate ligament (ACL) injuries occurred as a result of concerns about high rates of adverse events. Recently, the popularity of lateral extra-articular procedures has resurged, warranting an urgent evaluation of their safety profile. Purpose/Hypothesis: The aim of this study was to perform an interim analysis of the ongoing SANTI randomized controlled trial to determine whether combined ACL and anterolateral ligament reconstruction (ACL + ALLR) is associated with an increased rate of adverse outcomes when compared with isolated ACL reconstruction (ACLR). The hypothesis was that there would be no significant difference between groups at a minimum follow-up of 1 year. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Recruitment commenced in November 2016. Patients scheduled for ACLR were randomized to either isolated ACLR (with bone–patellar tendon–bone [BPTB] autograft) or combined ACL + ALLR (with hamstring tendon autograft). All patients with a minimum follow-up of 1 year by March 2019 were included. The evaluated parameters included complications and reoperations, knee laxity parameters, range of motion, and scores on the Tegner, Lysholm, International Knee Documentation Committee (IKDC), and Knee injury and Osteoarthritis Outcome Score (KOOS) instruments. Results: A total of 224 patients (112 in each group) with a mean ± SD follow-up of 12.3 ± 1.9 months (range, 12-19 months) formed the study population. A significantly higher rate of reoperation for cyclops syndrome was noted in the isolated ACLR group compared with the combined ACL + ALLR group (8.9% vs 0%, respectively; P = .0012). No significant differences were found in frequency of graft rupture (ACLR, 5.4%; ACL + ALLR, 0.9%; P = .1191), range of motion deficits, pain, or reoperation for meniscectomy between groups. No cases of postoperative infection, venous thromboembolism, or arthrofibrosis were seen. Subjective IKDC (81.2 vs 86.8; P = .0048), Lysholm (88 vs 92; P = .0131), and some components of the KOOS were significantly better in the combined ACL + ALLR group. Conclusion: This study demonstrates no evidence of an increased risk of short-term adverse events after combined ACL + ALLR compared with isolated ACLR with BPTB graft. Registration: NCT03740022 ( ClinicalTrials.gov Identifier)

scholarly journals Matrix-Augmented Bone Marrow Stimulation With a Polyglycolic Acid Membrane With Hyaluronan vs Microfracture in Local Cartilage Defects of the Femoral Condyles: A Multicenter Randomized Controlled Trial

2020 ◽  
Vol 8 (5) ◽  
pp. 232596712092293
Author(s):  
Johannes Glasbrenner ◽  
Wolf Petersen ◽  
Michael J. Raschke ◽  
Matthias Steiger ◽  
René Verdonk ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Polyglycolic Acid ◽  
Tissue Formation ◽  
Bone Marrow Stimulation ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Patient Reported

Background: Microfracture (MF) is an established operative treatment for small, localized chondral defects of the knee joint. There is evidence from animal studies that matrix augmentation of bone marrow stimulation (m-BMS) can improve the quality of the repair tissue formation. Purpose: To evaluate the therapeutic outcome of a matrix made of polyglycolic acid and hyaluronan as compared with a conventional MF technique. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: Patients between the ages of 18 and 68 years who had an articular femoral cartilage defect of 0.5 to 3 cm2 in the weightbearing area of the femoral condyles with indication for MF were included in this study. Patients were randomized and treated with either MF or m-BMS with Chondrotissue. Defect filling, as assessed on magnetic resonance imaging (MRI), at postoperative 12 weeks was defined as the primary outcome measure, with follow-up MRI at weeks 54 and 108. Follow-up data were also collected at 12, 54, and 108 weeks after surgery and included patient-reported clinical scores: visual analog scale for pain, Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee score, and 36-Item Short Form Health Survey. Results: MRI scans confirmed cartilage repair tissue formation in both groups 12 weeks after treatment. There was no significant difference between the m-BMS and MF groups in the percentage of defect filling at 12, 54, and 108 weeks postoperatively. No significant difference was found in terms of patient-reported clinical scores. Both groups showed significant improvement in 4 KOOS subscales—Pain, Activities of Daily Living, Sport and Recreation, and Quality of Life—at 54 and 108 weeks after treatment. Conclusion: This is the first randomized controlled trial comparing m-BMS with a polyglycolic acid matrix with hyaluronan with MF. The use of the Chondrotissue implant in m-BMS has been proven to be a safe procedure. No difference was found between m-BMS and MF in terms of patient-reported outcome scores and MRI assessment until postoperative 2 years. Long-term follow-up studies including histological assessment are desirable for further investigation. Registration: EUCTR2011-003594-28-DE (EU Clinical Trials Register).

scholarly journals Anterior Cruciate Ligament Reconstruction Using a Bone–Patellar Tendon–Bone Graft With and Without a Ligament Augmentation Device: A 25-Year Follow-up of a Prospective Randomized Controlled Trial

2018 ◽  
Vol 6 (11) ◽  
pp. 232596711880877 ◽  
Author(s):  
Marlene Mauseth Elveos ◽  
Jon Olav Drogset ◽  
Lars Engebretsen ◽  
Raymond Brønn ◽  
Trond Olav Lundemo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Knee Arthroplasty ◽  
Controlled Trial ◽  
Cruciate Ligament ◽  
Randomized Controlled ◽  
Bptb Graft ◽  
Ligament Augmentation ◽  
Anterior Cruciate ◽  
Bone Patellar Tendon

Background: Various grafts and ligament augmentation devices (LADs) have been used in the search for optimal reconstruction of the anterior cruciate ligament (ACL). Purpose: To compare 25-year follow-up results after ACL reconstruction using a bone–patellar tendon–bone (BPTB) graft with or without the Kennedy LAD. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: One hundred patients undergoing ACL reconstruction between 1991 and 1993 were randomized into 2 groups: reconstruction using a BPTB graft alone (BPTB group, 51 patients) or a BPTB graft with the Kennedy LAD (LAD group, 49 patients). The 25-year follow-up evaluation included a clinical knee examination, patient-reported outcome measures, and an assessment of radiological osteoarthritis (OA) according to the Ahlbäck classification. Additional outcomes were reruptures and knee arthroplasty. Results: Ninety-three patients (93%) were available for the follow-up evaluation: 48 patients in the BPTB group and 45 in the LAD group. Through telephone calls, 26 patients were excluded from further investigation because of reruptures and arthroplasty in the knee of interest; 67 patients were further investigated. A total of 43 of 44 (98%) and 42 of 44 (95%) patients had negative or 1+ Lachman and pivot-shift test results, respectively. The mean Lysholm score was 85 for the BPTB group and 83 for the LAD group. All mean Knee injury and Osteoarthritis Outcome Score (KOOS) subscale values were ≥73. There were no statistically significant differences between groups in any of these outcomes or regarding the Tegner score, radiological classification of OA, or number of ACL reruptures. Signs of radiological OA were detected in all patients, and severe radiological OA (Ahlbäck grade III, IV, or V) was detected in 32% of patients in the BPTB group and 21% of patients in the LAD group ( P = .37). There were 12 patients in the BPTB group and 7 in the LAD group who had documented reruptures ( P = .40). One patient in the BPTB group and 6 in the LAD group underwent knee arthroplasty ( P = .054). Conclusion: In the present study, there were no statistically significant differences between groups in any of the outcomes. After 25 years, 19% of patients had reruptures, 27% had severe radiological OA, and 7% underwent knee arthroplasty.

scholarly journals Effectiveness of Soft Tissue Massage for Nonspecific Shoulder Pain: Randomized Controlled Trial

2015 ◽  
Vol 95 (11) ◽  
pp. 1467-1477 ◽  
Author(s):  
Paul A. van den Dolder ◽  
Paulo H. Ferreira ◽  
Kathryn M. Refshauge
Keyword(s):  
Randomized Controlled Trial ◽  
Soft Tissue ◽  
Range Of Motion ◽  
Shoulder Pain ◽  
Controlled Trial ◽  
Study Objective ◽  
Randomized Controlled ◽  
Pain Disability ◽  
Significant Difference ◽  
Cessation Of Treatment

Background Soft tissue massage and exercise are commonly used to treat episodes of shoulder pain. Objective The study objective was to compare the effects of soft tissue massage and exercise with those of exercise alone on pain, disability, and range of motion in people with nonspecific shoulder pain. Design This was a randomized controlled trial. Setting The study was conducted in public hospital physical therapy clinics in Sydney, New South Wales, Australia. Participants The study participants were 80 people with an average age of 62.6 years (SD=12.2) who were referred to physical therapists for treatment of nonspecific shoulder pain. Intervention Participants were randomly assigned to either a group that received soft tissue massage around the shoulder and exercises (n=40) or a group that received exercise only (n=40) for 4 weeks. Measurements The primary outcome was improvement in pain, as measured on a 100-mm visual analog scale, 1 week after the cessation of treatment. Secondary outcomes were disability and active flexion, abduction, and hand-behind-back range of motion. Measurements were obtained at baseline, 1 week after the cessation of treatment, and 12 weeks after the cessation of treatment. Results The between-group difference in pain scores from the baseline to 12 weeks after the cessation of treatment demonstrated a small significant difference in favor of the group receiving exercise only (mean difference=14.7 mm). There were no significant differences between groups in any other variable. Limitations It was not possible to mask therapists or participants to group allocation. Diagnostic tests were not used on participants to determine specific shoulder pathology. Conclusions The addition of soft tissue massage to an exercise program for the shoulder conferred no additional benefit for improving pain, disability, or range of motion in people with nonspecific shoulder pain.

scholarly journals Acupuncture to Treat Primary Dysmenorrhea in Women: A Randomized Controlled Trial

2011 ◽  
Vol 2011 ◽  
pp. 1-11 ◽  
Author(s):  
Caroline A. Smith ◽  
Caroline A. Crowther ◽  
Oswald Petrucco ◽  
Justin Beilby ◽  
Hannah Dent
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Effect ◽  
Controlled Trial ◽  
Acupuncture Group ◽  
Control Group ◽  
Primary Dysmenorrhea ◽  
Menstrual Pain ◽  
Randomized Controlled ◽  
Significant Difference

We examined the effectiveness of acupuncture to reduce the severity and intensity of primary dysmenorrhea. A randomized controlled trial compared acupuncture with control acupuncture using a placebo needle. Eligible women were aged 14–25 years with a diagnosis of primary dysmenorrhea. Women received nine sessions of the study treatment over 3 months. The primary outcomes were menstrual pain intensity and duration, overall improvement in dysmenorrhea symptoms and reduced need for additional analgesia, measured at 3, 6 and 12 months from trial entry. A total of 92 women were randomly assigned to the intervention (acupuncture and control ). At 3 months although pain outcomes were lower for women in the acupuncture group compared with the control group, there was no significant difference between groups. Women receiving acupuncture reported a small reduction in mood changes compared with the control group, relative risk (RR) 0.72, 95% confidence interval (CI) 0.53–1.00, . Follow-up at 6 months found a significant reduction in the duration of menstrual pain in the acupuncture group compared with the control group, mean difference –9.6, 95% CI –18.9 to –0.3, , and the need for additional analgesia was significantly lower in the acupuncture group compared with the control group, RR 0.69, 95% CI 0.49–0.96, , but the follow-up at 12 months found lack of treatment effect. To conclude, although acupuncture improved menstrual mood symptoms in women with primary dysmenorrhea during the treatment phase, the trend in the improvement of symptoms during the active phase of treatment, and at 6 and 12 months was non-significant, indicating that a small treatment effect from acupuncture on dysmenorrhea may exist. In the study, acupuncture was acceptable and safe, but further appropriately powered trials are needed before recommendations for clinical practice can be made.

scholarly journals One day versus three days’ antibiotic prophylaxis in joint arthroplasty. A prospective randomized controlled trial

2021 ◽  
Vol 0 ◽  
pp. 1-5
Author(s):  
Mahmoud Elsaqa ◽  
Mahmoud A. Karim ◽  
Walid Ebeid ◽  
Mohamed Youness
Keyword(s):  
Randomized Controlled Trial ◽  
Antibiotic Prophylaxis ◽  
Antimicrobial Prophylaxis ◽  
Controlled Trial ◽  
Joint Arthroplasty ◽  
University Hospitals ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Significant Difference

Objectives: The objectives of the study was to compare the effectiveness of 1 day versus 3 days post-operative antibiotic prophylaxis in decreasing surgical site infection (SSI) rate after arthroplasty surgery. Methods: A prospective, randomized controlled trial was conducted over 1 year, in Cairo University Hospitals. The study included adult patients, who were scheduled for arthroplasty. Sixty patients were divided into two groups, 30 patients in each. The first group of patients received cefazolin for 1 day postoperatively (1-day group) and the other group for 3 days postoperatively (3-days group). Patients were randomized using the sealed opaque envelope method. Results: There were 32 females and 28 males. The mean patient age was 52 years (range 20–85 years). Wound infection developed in four cases (one case from the 1-day group and three cases from the 3-days group). All infections occurred within the early post-operative period, and completely resolved after proper management. Correlating the SSI to the type of surgery, operative time, the associated medical co-morbidities, and the duration of antimicrobial prophylaxis was not statistically significant. Conclusion: This study suggests that there is no significant difference in the prevalence of SSI between 1 day and 3 days of antimicrobial prophylaxis after primary joint arthroplasty within the average post-operative follow-up period of 3 months.

scholarly journals Effect of Electroacupuncture versus Sham Electroacupuncture in Patients with Knee Osteoarthritis: A Pilot Randomized Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Qi Wang ◽  
Hui Lv ◽  
Zhao-Tian Sun ◽  
Jian-Feng Tu ◽  
Yong-Wei Feng ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Muscle Strength ◽  
Knee Osteoarthritis ◽  
Range Of Motion ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Flexor Muscle ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Pilot Randomized Controlled Trial

Objective. To explore the feasibility of evaluating the effectiveness and safety of electroacupuncture versus sham electroacupuncture for patients with knee osteoarthritis (KOA). Method. A pilot randomized controlled trial was conducted at a teaching hospital in Beijing. A total of 30 patients with KOA (Kellgren grade II or III) were randomly allocated to an eight-week treatment of either electroacupuncture or sham electroacupuncture. Patients and outcome assessors were blinded to group allocation. The primary outcome was the proportion of responders achieving at least 1.14 seconds decrease in the Timed Up and Go Test (TUG) at week eight compared with baseline. The secondary outcomes included the knee range of motion, the knee extensor and flexor muscle strength, Lequesne index, 9-step stair-climb test (9-SCT), and TUG. Results. Of 30 patients allocated to two groups, 27 (90%) completed the study. The proportion of responders was 53.3% (8 of 15) for electroacupuncture group and 26.7% (4 of 15) for sham electroacupuncture group by the intention-to-treat analysis (P=0.264). There was no statistically significant difference in TUG between the two groups at eight weeks (P=0.856). The compliance rate measured according to patients who conformed to the protocol and had received treatments ≥20 times was 93.3% (28 of 30). The dropout rate was 20% (3 of 15). Adverse effects were not reported in the study. Conclusion. Our research demonstrated that further evaluation of the effectiveness of electroacupuncture versus sham electroacupuncture was feasible and safe for patients with KOA. Whether or not the electroacupuncture can improve the physical functions of knee joint, expand the knee range of motion, and increase the extensor and flexor muscle strength more significantly than sham electroacupuncture, future studies can be designed with larger sample size, randomization design and less biases. This trial is registered with NCT03366363.

Comparative effects of suture and non-suture surgical techniques on platysma after Thyroid surgery

2021 ◽  
Vol 15 (7) ◽  
pp. 1661-1664
Author(s):  
Hafiz Ali Wasay ◽  
Muhammad Aamir Jameel ◽  
Muhammad Imran Anwar ◽  
HaroonJavaid Majid ◽  
Sameen Tahir
Keyword(s):  
Randomized Controlled Trial ◽  
Thyroid Surgery ◽  
Controlled Trial ◽  
Surgical Techniques ◽  
Platysma Muscle ◽  
Randomized Controlled ◽  
Post Operative Pain ◽  
Increased Risk ◽  
Significant Difference ◽  
The Mean

Background: Thyroidectomy is a routine general surgical procedure and pain after thyroidectomy is responsible for prolongation of hospital stay and increased risk of respiratory complications. Platysma is routinely sutured at the end of thyroidectomy before wound closure. This randomized controlled trial was conducted to compare the outcome of suturing platysma muscle versus not suturing in thyroid surgery patients. Aim: To compare the outcome of suturing platysma muscle versus not suturing in thyroid surgery patients. Place and duration of study: Dept. of Surgery at Sh. Zayed Hospital, Lahore from 26-12-2019 to 25-06-2020. Methodology: It is a randomized controlled trial study which consists of 92 patients, between 18 to 70 years of age in both gender and planned for thyroidectomy for nodular thyroid enlargement. Patients were randomly allocated into two treatment groups. After excision of thyroid, platysma was sutured as per conventional practice in one group while in the other group platysma was not sutured. For pain assessment Visual Analogue Scale (VAS) was used to 24 hours after surgery. Results: The mean age was 36.4±13.4 years. The mean VAS score for post-operative pain measured 24 hours after the surgery was significantly lower in patients undergoing thyroidectomy without platysmal suture as compared to those with conventional suturing of platysma during thyroidectomy (2.37±0.97 vs. 3.67±1.28; p <0.001). Similar significant difference was also noted between groups and subgroups which based on patient’s age, gender, BMI and educational status. Conclusion: Avoiding the suturing of platysma significantly reduced the post-operative pain which advocates a change in current practice and encourages non-suturing of platysma to decrease the morbidity of patients in post-operative period. Keywords: Thyroidectomy, Platysma, Suture, No Suture, Pain

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