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Rupture clinical trials

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NCT ID: NCT06099600 Not yet recruiting - Ligament Rupture Clinical Trials

Anterior Cruciate Ligament Reconstruction

Préhab-LCA
Start date: April 2024
Phase: N/A
Study type: Interventional

This study evaluates the effectiveness of a pre-habilitation stay via digital monitoring on patients' short-term post-operative anxiety, compared with conventional management.

NCT ID: NCT06063915 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Injuries

Isoinertial Rehabilitation in Recovering Hamstring Strength Following Surgical Anterior Cruciate Ligament Reconstruction

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

The present experimental study aims to evaluate the effectiveness and tolerability of isoinertial strength training of the hamstrings using machines in patients with ACL-R during the intermediate post-intervention phases.

NCT ID: NCT06048874 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

FNB in ACL Recon Under SA

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.

NCT ID: NCT06048848 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

FNB in ACL Recon Under GA

Start date: September 18, 2023
Phase: N/A
Study type: Interventional

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under general anesthesia.

NCT ID: NCT05983692 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Mg Wire for Augmentation of ACL Reconstruction

Start date: June 2024
Phase: N/A
Study type: Interventional

Background: ACLR with autologous tendon graft is commonly used for the treatment of ACL injury. However, as the BTI healing is poor, this can lead to a failure rate of 5% in the first-year post-operation; a long and unpredictable rehabilitation period is expected and 35 % of patients never return to preinjury level of sports. Biological enhancement of BTI healing will help to cut down the medical cost related to poor prognosis. As a biodegradable metal, Mg has been developed as implants in orthopaedics for decades, yet without clinical implants developed for ACLR. Our team has been working on this area in the past 10 years preclinically. Our animal studies showed that supplementation of magnesium wire significantly promotes osteogenesis at BTI and improves mechanical strength in ACLR. Recently, our team developed a highly pure (99.99%) Mg wire (Fig 2) in collaboration with metallic engineers for tendon graft braiding during ACLR and with its improved physical quality and strength, it is suitable for graft braiding and then its degradation in vivo can promote tunnel bone formation and bone tendon interface integration. Objective: To investigate if anterior cruciate ligament (ACL) reconstruction augmented with magnesium (Mg) wire enhances osteogenesis at the bone-tendon interface (BTI), improving post-op rehabilitation and leading to better clinical outcomes. Hypothesis: Patients with ACL reconstruction using Mg wire will experience improved osteogenesis at the BTI, more effective rehabilitation, and superior knee strength and function. Design and Subjects: A multicentre, double-blinded, randomized controlled trial will recruit patients aged 18-30 with unilateral ACL tear for primary ACLR with a hamstring graft at four sites. Instruments: Mg-based wire. Interventions: Participants will receive either 99.99% purity Mg wire or 2-0 vicryl as a control. Main Outcomes: Osteogenesis will be assessed by High-Resolution Peripheral Quantitative Computed Tomography (HR-pQCT), muscle strength via Biodex tests, and functional recovery with International Knee Documentation Committee (IKDC) and Tegner scores at multiple post-op intervals. Knee stability will be checked with KT-1000 arthrometer. Blood samples will be analyzed for inflammatory markers and metabolic effects related to Mg wire. Data Analysis and Expected Results: A repeated-measures ANOVA will be utilized for data analysis. The expectation is that Mg wire augmentation will significantly enhance osteogenesis at the BTI and improve rehabilitation outcomes.

NCT ID: NCT05958953 Not yet recruiting - Maternal Sepsis Clinical Trials

PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes

PROACT PROM
Start date: September 2023
Phase: Phase 3
Study type: Interventional

Term pre-labor rupture of membranes (PROM) occurs in about 12% of pregnancies and the time between PROM and delivery increases the risk of maternal/fetal infections. However, conflicting results are reported by studies investigating risks and benefits of expectant management versus induction of labor (IOL). Expectant management was associated with maternal and fetal infectious complications and subsequent increased risk of maternal and neonatal morbidity. Studies suggest that the increase in infectious risk for both is proportional to the increase in the time interval between the ROM and the birth, others reject this assumption. In PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes (PROACTIVE PROM) on admission, PROM will be diagnosed. After 6 hours from the rupture of membranes, the woman will then be assessed for eligibility. A 1:1 randomization will follow within two hours (6-8 hours from PROM) in two distinct arms: 1) Expectant management 2) Active menagement (early IOL within 8 hours of rupture of membranes). The first objective of this study is to evaluate whether active management of women with PROM (early induction) reduces the newborn need of respiratory support. The secondary objectives of this study are related to the safety of the active management assessed through the rate of stillbirths, the onset of infections in both mother and fetus and the length of hospitalization of the dyads. Moreover, another objective is to reduce the use of antibiotic treatments (ATB) in both mothers and newborns. The rationale of this study is that reducing the time between the PROM and delivery through an early IOL will reduce the adverse maternal and neonatal outcomes. The hypothesis underneath this trial comes from a preliminary retrospective cohort study conducted in Modena, which included 2689 mother-neonates dyads from singleton pregnant women at term. In deliveries of ROM >24 hours significantly more neonates required ventilatory support than those born within 24 hours, although no significant differences were found regarding overt infections. According to the Cochrane database, expectant management of PROM is associated with maternal and fetal infectious complications and subsequent increased risk of maternal and neonatal morbidity together with an increased risk of ATB use. The increase of infectious risk is proportional to the time elapsed since the rupture of the membranes (ROM) and birth. However, unpublished data from our group suggest that respiratory distress requiring interventions may be frequently caused by intrinsic inflammatory-related effects of prolonged ROM rather than infection; this is suggested by an increase of C-reactive protein levels in neonates with mild respiratory signs untreated with antibiotics. In addition, in a survey performed in our country expectant management increased intrapartum antibiotic prophylaxis (IAP), although not strictly indicated by the most current guidelines. On the light of these data, it appears reasonable to promote induction of labor, to prevent complication caused not only by the infectious risk mentioned above, but also respiratory distress, probably associated to a neonatal maladaptation, in non-infectious newborns. On the other hand, it should also be considered that 75% of women enter labor spontaneously within 24 hours from PROM and induction of labor (IOL) might not be needed in such cases.

NCT ID: NCT05957614 Not yet recruiting - Clinical trials for Achilles Tendon Rupture

Effects of Acupuncture-assisted Rehabilitation Protocol for Achilles Tendon Rupture

Start date: July 15, 2023
Phase: N/A
Study type: Interventional

This prospective study is to compare the rehabilitation effect between the patients with achilles tendon rupture using traditional rehabilitation protocol and acupuncture-assisted rehabilitation protocol. The main question it aims to answer is whether acupuncture is an effective rehabilitation treatment. The patients are divided into the traditional rehabilitation group and acupuncture assisted rehabilitation group. The time of return to light sports activity and other indicators of the two groups will be compared.

NCT ID: NCT05924178 Not yet recruiting - Clinical trials for Anterior Cruciate Ligament Rupture

Effects of Preoperative Rehabilitation on Tendon Healing and Bone Mineral Density After ACLR

Start date: July 10, 2023
Phase: N/A
Study type: Interventional

To explore the effect of preoperative exercise rehabilitation on bone mineral density, tendon bone healing, change of cartilage, and gait feature in patients with anterior cruciate ligament rupture.

NCT ID: NCT05849584 Not yet recruiting - Childbirth Problems Clinical Trials

Levator Hiatal Dimensions and Mode of Delivery

LEVDIM
Start date: February 5, 2024
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to learn about how muscle dimensions of the pelvic floor measured during pregnancy in primigravida impact birth mecanics and mode of delivery. Tha main aims are to 1. Explore associations between mode of delivery and hiatal dimensions measured by transperineal ultrasound antenatally and 2. Explore the association between duration of 2nd stage of labour and hiatal dimensions. A pelvic floor ultrasound examination will be performed between pregnancy week 12 and 20 and levator ani muscle hiatal dimensions will be compared between women having a normal vaginal delivery and women with emergency cesarean or operative vaginal deliveries.

NCT ID: NCT05817578 Not yet recruiting - Rotator Cuff Tears Clinical Trials

Profiling the RCRSP Patient: a Pain Phenotype Classification Algorithm

Start date: September 2, 2023
Phase:
Study type: Observational

The aim of this study is to collect a sum of different characteristics that have been mentioned previously in people presenting with RCRSP and by clustering them to create a phenotype system which may assist the individualisation of their management