title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Data availability | The pharmacometric reproducibility script (without specifics of clinical data) is available at | PMC10539503 | ||
Competing interests | The authors declare no competing interests. | PMC10539503 | ||
References | PMC10539503 | |||
Main | glioma, tumors, tumor | PROLIFERATION, GLIOMA, TUMORS, TUMOR | Pediatric low-grade glioma (pLGG) is the most common childhood central nervous system (CNS) tumor, representing approximately 30% of pediatric brain tumorsMost pLGGs are driven by genomic alterations affecting components of the mitogen-activated protein kinase (MAPK)/extracellular signal-regulated kinase (ERK) pathway,... | PMC10803270 |
Results | PMC10803270 | |||
Endpoints | ADVERSE EVENTS, SECONDARY | The primary endpoint in arm 1 was the ORR as assessed by the IRC according to RANO-HGG criteria. Secondary endpoints for arm 1 included ORR by RAPNO criteria per IRC; clinical benefit rate (CBR), progression-free survival (PFS), duration of response (DOR) and time to response (TTR), per IRC by RANO-HGG and RAPNO criter... | PMC10803270 | |
Patients and disposition | Between 22 April 2021 and 26 January 2023, 137 patients were enrolled to arms 1 and 2 and received tovorafenib—77 in arm 1 and 60 in arm 2. Seven (9%) patients in arm 1 and 21 (35%) patients in arm 2 received tovorafenib as a liquid formulation; all other patients received the tablet formulation. As of the datacut, 102... | PMC10803270 | ||
Maximal change in tumor size for evaluable patients. | Per RANO-HGG ( | PMC10803270 | ||
Swimlane plot of TTR and DOT. | Per RANO-HGG ( | PMC10803270 | ||
RAPNO criteria (secondary endpoints) | tumor, SD, PD, BOR, MR, tumors | MINOR, TUMORS, TUMOR | The ORR per RAPNO criteria was 51% (95% CI: 40–63), including 28 (37%; 95% CI: 26–49) patients with a PR (≥50% reduction from baseline by sum of the product of the perpendicular diameters (SPPD)) and 11 (14%; 95% CI: 8–24) patients with a minor response (MR; 25–49% reduction from baseline by SPPD). Twenty-three (30%) p... | PMC10803270 |
RANO-LGG criteria (post hoc exploratory endpoints) | tumor, SD, PD, BOR, tumors | TUMOR, TUMORS | The ORR per RANO-LGG criteria was 53% (95% CI: 41–64), including 20 (26%; 95% CI: 17–38) patients with a PR and 20 (26%; 95% CI: 17–38) with an MR. Twenty-three (30%) patients had a BOR of SD, giving a CBR of 83%. ORR was similar in patients with tumors harboring Figure Similar to the RAPNO analysis, there was a subset... | PMC10803270 |
Response to tovorafenib in patients with PD while on a MAPKi as their most recent prior therapy (post hoc analysis) | crieria | A post hoc analysis was completed using all three radiological criteria to assess responses to tovorafenib in patients who received a MAPKi as their most recent line of therapy and discontinued due to progression. For RANO-HGG criteria, 33% (n = 15) of patients who had progressed on a MAPKi as their most recent prior t... | PMC10803270 | |
Safety | intercurrent infectious disease, fatigue, seizure, hyponatremia, vomiting, anemia, rash, pyrexia, hemorrhage, tumor hemorrhage, decreased appetite, TRAEs | RTI, CORONAVIRUS DISEASE 2019, EVENT, HYPONATREMIA, ANEMIA, HEMORRHAGE, ADVERSE EVENT, RESPIRATORY TRACT INFECTION, EVENTS | Among 137 patients (arms 1 and 2), 118 (86%) had been treated for at least 6 months and 67 (49%) for at least 1 year. All patients experienced at least one treatment-emergent adverse event (TEAE). The most common TEAEs at any grade occurring in ≥20% of patients were hair color changes (76%), anemia (59%) and elevated c... | PMC10803270 |
Discussion | tumor, seizures, bone marrow failure, Intratumoral hemorrhage, cancer, rash, hemorrhage, heterogenous, fatigue, hypothalamic/chiasmatic gliomas, anemia, pruritus, paronychia, heterogeneous disease, endocrine abnormalities, TRAEs, leptomeningeal disease, intratumoral hemorrhage, PD, tumor hemorrhage, deaths, tumors, der... | TUMOR, BONE MARROW FAILURE, ENDOCRINE DISORDER, CANCER, DISEASE, BLEEDS, ANEMIA, HEMORRHAGE, SECONDARY, PARONYCHIA, TUMORS, DERMATITIS | In this international, multicenter, single-arm phase 2 trial, tovorafenib monotherapy resulted in clinically meaningful, rapid and durable tumor responses in children and young adults with This trial was designed with IRC-assessed ORR as the primary endpoint, evaluated according to RANO-HGG criteria. These criteria ass... | PMC10803270 |
Methods | PMC10803270 | |||
Trial design | FIREFLY-1 (PNOC026; Sex and/or gender were not considered in the trial design as no sex differences have been seen in previous clinical trials in pLGG, although, in line with rates generally seen in childhood cancerTovorafenib was administered at the recommended phase 2 dose of 420 mg mAn independent data safety monito... | PMC10803270 | ||
Data collection | CRF | CRF | Clinical data required by the protocol were entered into the electronic case report forms (eCRFs) and used a fully validated secure web-enabled electronic data capture (EDC) system, Medidata Classic Rave 2022.3.2, which is compliant with 21 CRF Part 11 requirements. Automatic validation edit checks in the EDC system an... | PMC10803270 |
Eligibility | tumor, ophthalmopathy | CENTRAL SEROUS RETINOPATHY, TUMOR, CARDIOVASCULAR DISEASE, OPHTHALMOPATHY, DISEASE, NEUROFIBROMATOSIS TYPE 1 | Full inclusion and exclusion criteria are listed in the trial protocol, located in the Patients were excluded if their tumor harbored an additional previously known or expected to be activating molecular alteration; if they had symptoms of clinical progression without radiographically recurrent or radiographically prog... | PMC10803270 |
Trial endpoints | tumor | DISEASE, TUMOR | The assessment of response was undertaken using three different radiological response assessment criteria: RANO-HGG criteria, which assess tumor response primarily based on T1-weighted, contrast-enhanced imaging, and RAPNO-LGG and RANO-LGG criteria, both of which assess tumor response based primarily on non-enhancing d... | PMC10803270 |
Assessments | intraspinal disease, primary malignancy, optic pathway glioma, IE, disability | ADVERSE EVENT, DISEASE, DISEASE, EVENT | Disease assessments in arm 1 were conducted by MRI of the brain and spine and were performed at screening up to 28 d before first dose, at the end of cycle 3 and then at the end of every three cycles thereafter. Spinal scans were only required to be repeated after screening in patients with known or clinically suspecte... | PMC10803270 |
Statistical considerations | Cancer | DISEASE, CANCER | In terms of the ‘evaluable’ population, patients ‘evaluable for efficacy’ were all patients enrolled in the trial who received at least one dose of trial treatment and met the definition for the prespecified efficacy analyses criteria (RANO-HGG, RAPNO and RANO-LGG)The primary endpoint analysis was performed in the arm ... | PMC10803270 |
Management of cutaneous AEs | pruritus, erythema, ulcerative or bullous dermatitis, rash/dermatitis | EVENT, ERYTHEMA, ERUPTION, VESICULAR ERUPTION, GENERALIZED ERYTHRODERMA | Guidance for the management of rash/dermatitis was included in the trial protocol, in line with the stepwise approach proposed by Song et al.In the event of grade 2 macular or papular eruption, erythema with pruritus or other associated symptoms, localized desquamation or other lesions covering less than 50% of body su... | PMC10803270 |
Key protocol amendments | PMC10803270 | |||
Current version 3.0, 21 October 2021 | The protocol was amended primarily to add two new arms to the trial, to add a powder for reconstitution formulation of tovorafenib and to incorporate other changes based on feedback from regulatory authorities. This version of the full trial protocol (some confidential information redacted) is in the | PMC10803270 | ||
Version 2.0, 23 October 2020 | The protocol was amended primarily to change the recommended phase 2 dose of tovorafenib from 530 mg m | PMC10803270 | ||
Clinical trial registration | The study is registered on ClinicalTrials.gov as | PMC10803270 | ||
Reporting summary | Further information on research design is available in the | PMC10803270 | ||
Online content | Any methods, additional references, Nature Portfolio reporting summaries, source data, extended data, supplementary information, acknowledgements, peer review information; details of author contributions and competing interests; and statements of data and code availability are available at 10.1038/s41591-023-02668-y. | PMC10803270 | ||
Supplementary information |
Supplementary Tables 1 and 2 and trial protocol.Reporting Summary | PMC10803270 | ||
Extended data | PMC10803270 | |||
Tumor kinetics. | Fig.
| PMC10803270 | ||
Swimlane plot of time to response and duration of therapy per RANO-LGG criteria. | MR, glioma | MINOR, GLIOMA | In patients with response, symbols indicate the start of response (MR or PR). If initial response improved with continued treatment (from MR to confirmed PR), both the timepoint of the initial response and the timepoint that response initially improved are marked accordingly. BRAFi, BRAF inhibitor; LGG, low-grade gliom... | PMC10803270 |
Extended data | is available for this paper at 10.1038/s41591-023-02668-y. | PMC10803270 | ||
Supplementary information | The online version contains supplementary material available at 10.1038/s41591-023-02668-y. | PMC10803270 | ||
Acknowledgements | D.H., Cancer | WRIGHT, CANCER | This trial was funded by Day One Biopharmaceuticals. We thank the patients, families, caregivers and clinical investigators for their participation in the FIREFLY-1 trial. We are deeply grateful for the site coordinators and trial staff who are instrumental in making this work possible. The authors would like to thank ... | PMC10803270 |
Author contributions | All authors had access to primary clinical trial data. All authors vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. All authors contributed substantially to the concept and design of the manuscript, data analysis and interpretation and writing of the manuscript. All... | PMC10803270 | ||
Peer review | PMC10803270 | |||
Data availability | The trial protocol (confidential information redacted) is provided in the | PMC10803270 | ||
Competing interests | D.H. | L.B.K. has received consulting fees from Blueprint Medicine as DSMB Chair and has contracted institutional research with Novartis, Regeneron Pharmaceuticals, Day One Biopharmaceuticals, Spring Works Therapeutics, Bristol Myers Squibb and SonALAsense. L.B.K. also owns stock in Onconova Therapeutics. J.R.H. has received ... | PMC10803270 | |
References | PMC10803270 | |||
Background | gynecologic cancer | GYNECOLOGIC CANCER | Patients with gynecologic cancer receiving chemotherapy often report unmet supportive care needs. Compared with traditional face-to-face clinical interventions, mobile health can increase access to supportive care and may address patients’ needs. Although app-based support programs have been developed to support patien... | PMC10682921 |
Objective | gynecologic cancer | GYNECOLOGIC CANCER | The aim of this study was to examine the efficacy of a mobile app for gynecologic cancer support (MGCS) for patients with gynecologic cancer receiving chemotherapy in China. | PMC10682921 |
Methods | gynecologic cancer, Mishel | SECONDARY, GYNECOLOGIC CANCER | A multicenter randomized controlled trial was conducted in 2 university-affiliated hospitals in China. A total of 168 Chinese patients with gynecologic cancer were recruited and randomized to receive routine care or MGCS program plus routine care for 24 weeks. The Mishel uncertainty in illness theory guided the develop... | PMC10682921 |
Results | In this trial, 67 patients in the control group and 69 patients in the intervention group completed 2 follow-up assessments (response rate, 136/168, 81%). At 12 weeks, no significant differences were observed in any of the health outcomes between the 2 groups. At 24 weeks, compared to patients in the control group, tho... | PMC10682921 | ||
Conclusions | cancer, gynecologic cancer | CANCER, GYNECOLOGIC CANCER | The MGCS program demonstrated efficacy in supporting patients with gynecologic cancer receiving chemotherapy. This trial illustrates that an app-based program can be incorporated into routine care to support patients with cancer and suggests that allocation of more resources (grants, manpower, etc) to mobile health in ... | PMC10682921 |
Trial Registration | Chinese Clinical Trial Registry ChiCTR2000033678; https://www.chictr.org.cn/showproj.html?proj=54807 | PMC10682921 | ||
Introduction | PMC10682921 | |||
Background | cancer, ovarian cancers | CANCER, OVARIAN CANCER | Gynecologic cancer (GC) is a global public health concern, with cervical, endometrial, and ovarian cancers being the 3 most common GCs [ | PMC10682921 |
Conceptual Framework | gynecologic cancer, Mishel | GYNECOLOGIC CANCER | Many patients with GC receiving chemotherapy experience high levels of uncertainty in illness [We developed the mobile app for gynecologic cancer support (MGCS) program under the conceptualization of Mishel uncertainty in illness theory. The primary aim of this trial was to examine whether the MGCS program can effectiv... | PMC10682921 |
Methods | PMC10682921 | |||
Study Design | A multicenter randomized controlled trial was conducted. This trial was registered in the Chinese Clinical Trial Registry (ChiCTR2000033678). The protocol for this trial was published and strictly followed at all stages [ | PMC10682921 | ||
Participants and Settings | cancers | CANCERS, OVARIAN CANCERS | Trial participants included patients who were (1) aged 18 years and older, (2) first diagnosed with GC (including cervical, endometrial, and ovarian cancers), (3) starting the first cycle of chemotherapy, (4) able to access the internet via a mobile phone, (5) contactable, and (6) able to read and write Chinese. Patien... | PMC10682921 |
Sample Size Calculation and Sample Randomization | The primary health outcome of uncertainty was used to calculate the sample size. Previous research on a face-to-face uncertainty management intervention reduced uncertainty in illness for patients with HIV with an effect size of 0.53 [ | PMC10682921 | ||
Ethics Approval | Ethics approval was obtained from the ethics committees of the School of Medicine in Xiamen University (XDYX2019013) and 2 university-affiliated hospitals (Zhongshan Hospital: XMZSYYKY2020-113 and First Affiliated Hospital: FA2020-037). All participants were informed that their participation was voluntary. Participants... | PMC10682921 | ||
Intervention | gynecologic cancer, Mishel | EFFECTS OF CHEMOTHERAPY, GYNECOLOGIC CANCER | A health care team consisting of 3 gynecologic oncologists, 1 psychologist, and 2 oncology nursing specialists designed the MGCS program. An information technology company technically developed and subsequently maintained the MGCS program. The Mishel theory outlines 4 main components of uncertainty in illness: antecede... | PMC10682921 |
Outcome Measures | primary disease, cancer | CANCER | Self-reported demographic and clinical characteristics questionnaires were designed by the research team. Demographic characteristics consist of age, marital status, educational level, current employment, monthly family income (in USD), and payment methods. Clinical characteristics include primary disease site, stage o... | PMC10682921 |
Primary Outcome | Participants’ uncertainty in illness was assessed with the Chinese version of the 25-item Mishel Uncertainty in Illness Scale for Adults (MUIS-A) [ | PMC10682921 | ||
Secondary Outcomes | Cancer | CANCER | Participants’ QoL was measured with the Chinese version of the 27-item Functional Assessment of Cancer Therapy-General (FACT-G, version 4) [ | PMC10682921 |
Data Collection | BLIND | Data were collected between February 2021 and March 2022. The oncologist informed eligible patients with GC about the MGCS program. Patients with GC who expressed an interest in this study were approached by a member of the research team to provide more detailed information. After signing the paper consent form, all pa... | PMC10682921 | |
Statistical Analysis | SPSS (version 25; IBM Corp) was applied to analyze all the data [ | PMC10682921 | ||
Results | PMC10682921 | |||
Efficacy of the MGCS Program | PMC10682921 | |||
Secondary Outcomes | gynecologic cancer, Cancer | GYNECOLOGIC CANCER, CANCER | At 12 weeks (T1), there was no significant difference in the QoL between the 2 groups. At 24 weeks (T2), after adjusting for the baseline scores, participants who received the MGCS program plus routine care exhibited a significant improvement in QoL compared with participants who only received routine care (Mean change... | PMC10682921 |
Usage Data of the MGCS Program | gynecologic cancer | GYNECOLOGIC CANCER | The MGCS program usage varied considerably. During the 24-week intervention, the mean of the total usage duration was 85.23 minutes (SD 196.24; maximum 1144.60; median 16.53, IQR 2.12-75.20), and the mean of the total log-in frequency was 67.90 times (SD 106.01; maximum 565; median 21, IQR 4-94). The weekly topics and ... | PMC10682921 |
Discussion | PMC10682921 | |||
Principal Results | colorectal cancer | COLORECTAL CANCER | The strengths of this study include the clinical importance of an app for supporting patients with GC and the theory-derived intervention as well as the methodological rigor in collecting and analyzing data. The MGCS program is the first expert-led app-based program designed in China for patients with GC receiving chem... | PMC10682921 |
Limitations | VULVAR CANCER | This trial has several limitations. We only recruited patients with 3 types of GCs, while those with other GCs (eg, vulvar cancer) were excluded. Patients with GC recruited from the 2 participating university-affiliated hospitals may not represent those in the hospitals located in rural or remote areas. Implementing th... | PMC10682921 | |
Conclusions | cancer, Cancer | CANCER, CANCER | This trial demonstrates the efficacy of an app-based program to decrease uncertainty in illness and improve the QoL of patients with GC receiving chemotherapy. This trial illustrates how an app-based support program can be incorporated into clinical practice. Translating the intervention into clinical practice can be s... | PMC10682921 |
Abbreviations | cancer, Cancer | CANCER | Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online TelehealthFunctional Assessment of Cancer Therapy-Generalgynecologic cancerMD Anderson Symptom Inventorymobile app for gynecologic cancer supportMultidimensional Scale of Perceived Social SupportMishel Uncertainty in Illn... | PMC10682921 |
Data Availability | The data sets generated and analyzed during this study are available in the Mendeley repository: 10.17632/cmn7zfbwby.2 | PMC10682921 | ||
BACKGROUND: | ABI, brain injury | ORCID: 0000-0003-1772-2037ORCID: 0000-0002-6889-4552Sleep disturbances are common after acquired brain injury (ABI) and have a negative impact on functioning. | PMC10657700 | |
OBJECTIVE: | sleep disturbances, ABI | This study examines whether a short add-on therapy for sleep disturbances in individuals with ABI is effective in addition to rehabilitation treatment as usual. | PMC10657700 | |
METHODS: | ABI, fatigue, anxiety, insomnia, depression | In the randomized-controlled study, 54 adults with ABI and self-reported sleep disturbances receiving outpatient rehabilitation services were randomized in two groups: one receiving a sleep intervention (based on cognitive behavioural therapy for insomnia (CBT-I)) in addition to their rehabilitation treatment (CBT-I + ... | PMC10657700 | |
RESULTS: | fatigue | The short add-on sleep therapy resulted in improvements in sleep quality in the CBT-I + TAU group as compared to the TAU group (ES = 0.924). Furthermore, the CBT-I + TAU group reported less dysfunctional beliefs and attitudes about sleep and were better able to cope with fatigue compared to the TAU group. | PMC10657700 | |
CONCLUSIONS: | The application of this short add-on sleep intervention could be implemented in neuropsychological rehabilitation settings. | PMC10657700 | ||
Introduction | ABI, mood disorders, decline in cognitive abilities, fatigue, sleep disturbances, anxiety, brain injury, insomnia, depression | Individuals with acquired brain injury (ABI) often have a wide range of impairments which may result in long-term difficulties in everyday life (Sleep disturbances negatively affect health, resulting in a lower quality of life, decline in cognitive abilities and a higher risk of mood disorders (According to the Europea... | PMC10657700 | |
Method | PMC10657700 | |||
Participants | drug abuse or dependence, sleep disorder, fatigue, brain injury, psychosis, brain damage, Parkinson, Multiple Sclerosis), ideations, disability | NEURODEGENERATIVE DISORDERS, RESTLESS LEGS SYNDROME, OBSTRUCTIVE SLEEP APNOEA | Participants were recruited from the outpatient department of the Rehabilitation Medical Centre Klimmendaal in Arnhem, The Netherlands. To be eligible for inclusion, participants (1) had to have an acquired brain injury (≥3 months post-injury), (2) had self-reported sleep problems which are associated with disability i... | PMC10657700 |
Outcome measures | Anxiety, fatigue, DMFS, depressive, Depression, Fatigue | For evaluation of the effects of the short add-on sleep therapy, validated Dutch versions of four self-reported questionnaires were administered, including the Pittsburg Sleep Quality Index (PSQI), the Dutch Multi-Factor Fatigue Scale (DMFS), the Hospital Anxiety and Depression Scale (HADS) and the Dysfunctional Belief... | PMC10657700 | |
Intervention | sleep-related | The add-on sleep intervention comprised four sessions over six weeks and is based on CBT-I principles. The sleep intervention was added to the regular rehabilitation program, which varied between individuals based on their rehabilitation goals. Thus, the add-on sleep intervention is a short variant of CBT-I which is in... | PMC10657700 | |
Procedure | ABI | This randomized controlled trial was conducted between September 2018 and February 2022, with the first patient included on 10 September 2018. Potential participants were referred by their neuropsychologists in the first weeks of their rehabilitation program. Neuropsychologists screened possible participants for inclus... | PMC10657700 | |
Statistical analyses | For all variables the assumption of normality was checked and corrected for, if necessary. IBM SPSS 27 was used for the statistical analyses (IBM Corp., Armonk, USA). Demographic and baseline data of the two groups were analyzed using two-tailed independent To determine the efficacy of the short add-on therapy, per pro... | PMC10657700 | ||
Discussion | ABI, fatigue, anxiety, sleep disturbances, sleep-related cognitions, depressive | This randomized controlled trial (RCT) investigated the effectiveness of a short add-on CBT-I-based therapy for sleep disturbances in individuals with ABI in addition to rehabilitation treatment as usual. The CBT-I + TAU group improved more on self-reported sleep quality, dysfunctional beliefs and attitudes about sleep... | PMC10657700 | |
Limitations and future directions | sleep disturbances | Although our findings provide valuable information on treatment efficacy of a short CBT-I treatment for sleep disturbances in the ABI population, some limitations should be noted. First, the present study aimed to examine the effectiveness of an add-on sleep intervention in individuals with ABI. The Consolidated Standa... | PMC10657700 | |
Conclusions | depressive, ABI, fatigue, anxiety | Sleep disturbances are common following ABI and have a negative impact on emotional well-being and cognitive functioning. The present study shows that a short CBT-I based sleep intervention produced significant improvements in sleep quality and fatigue in people with ABI in addition to rehabilitation treatment as usual... | PMC10657700 | |
Conflict of interest | None to report. | PMC10657700 | ||
References | PMC10657700 | |||
Background | ANTERIOR | Anterior cruciate ligament (ACL) reconstruction aims to restore anteroposterior and rotatory stability to the knee following ACL injury. This requires the graft to withstand the forces applied during the process of ligamentisation and the rehabilitative period. We hypothesise that the use of suture tape augmentation of... | PMC10037835 | |
Methods | arthrometer, ACL rupture | STERILE, EFFUSION, PATHOLOGY, COMPLICATION | The study design will be a parallel arm 1:1 allocation ratio randomised controlled trial. Sixty-six patients aged 18 and over waitlisted for primary ACLR will be randomised. Patients requiring osteotomy and extra-articular tenodesis and who have had previous contralateral ACL rupture or repair of meniscal or cartilage ... | PMC10037835 |
Discussion | COMPLICATION | This will be the first randomised trial to investigate the effect of suture-tape augmentation of ACLR on either objective or subjective outcome measures. The use of suture-tape augmentation in ACLR has been associated with promising biomechanical and animal-level studies, exhibiting equivalent complication profiles to ... | PMC10037835 | |
Trial registration | Australia New Zealand Clinical Trial Registry ACTRN12621001162808. Universal Trial Number (UTN): U1111-1268-1487. Registered prospectively on 27 August 2021 | PMC10037835 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13063-023-07127-0. | PMC10037835 | ||
Keywords | PMC10037835 | |||
Introduction | PMC10037835 | |||
Background and rationale {6a} | arthrometer, knee laxity | KNEE OSTEOARTHRITIS, COMPLICATION | The anterior cruciate ligament (ACL) acts as the primary static constraint to anterior translation and internal rotation of the tibia [Recently, the use of suture tape (a modified suture composed of non-absorbable, braided polyethylene/polyester suture) acting as a ‘seatbelt’ for in situ autograft has been proposed [Th... | PMC10037835 |
Objectives {7} | PMC10037835 | |||
Primary objective | arthrometer | The objective of this study is to compare residual anterior knee laxity after primary hamstring autograft ACLR with or without suture tape (ST) augmentation, as measured by the GNRB ligament arthrometer at 2 years post-operatively. The primary outcome measure will be the difference between operative and non-operative l... | PMC10037835 | |
Secondary objectives | knee ACL rupture, synovitis, pain, effusion, arthrofibrosis | RSI, SYNOVITIS, COMPLICATION, STERILE, SECONDARY, EFFUSION, COMPLICATIONS, ARTHROFIBROSIS | The secondary objectives are to compare PROMs, complication rates, return to sport rates and examination findings between SA and ST ACLR. The PROMs assessed will include the Marx activity scale, ACL RSI, IKDC, the KOOS QOL and the EQ5D-5L scale. Complications assessed will include post-operative pain levels, graft fail... | PMC10037835 |
Trial design {8} | This study is a randomised controlled single-blind interventional 2-arm parallel-group superiority trial utilising 1:1 allocation ratio comparing ACLR with suture tape augmentation (ST-ACLR) to standard hamstring ACLR technique (ACLR) with femoral adjustable cortical fixation and tibial interference screw. This study i... | PMC10037835 | ||
Methods: participants, interventions and outcomes | PMC10037835 |
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