Pontifical Catholic University of Rio Grande Do Sul

This study aims to evaluate bone formation in grafts in terms of its quality (density), quantity (volume) and maturation obtained with the application of a tissue-engineered bone grafting compound containing concentrated autogenous cell-culture medium (CM) and a synthetic bone substitute. The present study was designed as an experimental prospective split-mouth randomized controlled clinical trial. After protocol approval by the Research Ethics Committee, a total of 20 consecutive participants in need of maxillary reconstruction aiming implant-supported oral rehabilitation will be invited to join the study. To collect autogenous adipose tissue-derived mesenchymal stem cells (hASCs), an outpatient lipoplasty procedure at the abdominal area of each patient will be performed. To isolate and expand hASCs from the lipoaspirate, specific cell culture protocols will be followed, resulting in cultured viable cells and their conditioned medium (CM). Cells and CM will be then separated by a sequence of filters and centrifugation, and isolated CM will be frozen. ELISA will analyze the presence of chemokines and their concentration in CM before grafting. Following pre-op surgical planning, both maxillary sinuses of each patient will be grafted internally applying a lateral window to each sinus. The bony floor of the test maxillary sinus will be augmented with synthetic bone substitute (BoneCeramic™ 1-2 mm) mixed with 10 to 15 ml of CM (test). The control site will receive bone substitute with saline. Lateral windows in both sinuses will be then closed with a collagen membrane (Bio-Gide™). After 6 months, first-stage implant surgery will be performed placing 6 implants in each patient. Registration of implant stability by manual torque wrench will be performed. Also, bone biopsies from each drilled implant site will be collected for histology, histomorphometry and immunohistochemistry (RT-PCR). Tomographic evaluation of the bone formation will include cone beam computed tomographies (CBCTs) at pre-operative [Baseline], 90 [T1] and 180 [T2 = implant placement] days for bone 3D image analysis.

This study investigates whether wearing specific back braces (spinal orthoses) can improve movement and physical function in older adults (60 years and older) with hyperkyphosis, a forward curvature of the upper spine. By testing two types of braces, the study seeks to find effective ways to manage hyperkyphosis and enhance mobility, independence, and quality of life in this population.
Study Purpose
The purpose is to evaluate the impact of two types of thoracic spinal orthoses on functional mobility, which includes walking, muscle function, and overall physical activity. This information will help healthcare providers better understand how braces can be used to manage hyperkyphosis and improve daily functioning for older adults.
Who Can Participate?
The study will include adults aged 60 or older who have been diagnosed with hyperkyphosis. Eligible participants will be randomly assigned to one of three groups:
1. Group 1: Participants will use the Triple-Adjustable Posture Corrector (TAPC), a brace designed to improve posture and reduce kyphosis.
2. Group 2: Participants will use the Generation Dynamic Osteoporosis Brace (G-DOB), another type of spinal brace targeting posture and mobility.
3. Control Group: Participants will not wear any brace.
How the Study Works
The study will run for 16 weeks. Participants in the brace groups will wear their assigned braces throughout the day, except during specific activities like bathing, sleeping, and swimming. No other changes to their daily routines will be required.
At the start and end of the study, participants will undergo assessments to measure their physical function and mobility. These assessments will include:
* Gait analysis: Evaluates walking patterns using advanced 3D motion technology.
* Muscle strength and joint function testing: Measures how well muscles and joints are working using isokinetic dynamometry.
* Muscle activity recording: Tracks how muscles respond during movement using surface electromyography (EMG).
* Physical activity monitoring: Captures activity levels using accelerometers, which are small devices that track movement.
Why Is This Study Important?
Hyperkyphosis can lead to challenges in daily life, such as difficulty walking, decreased balance, pain, and a higher risk of falls. While physical therapy and exercise are common treatments, many older adults need additional support to manage the condition. Spinal orthoses may offer a practical, non-invasive option to improve posture, reduce symptoms, and increase physical activity.
By comparing the effects of these two braces, the study aims to:
1. Determine whether these orthoses improve functional mobility, such as walking and muscle performance.
2. Provide evidence to guide healthcare professionals in using braces to treat hyperkyphosis.
3. Develop a standardized approach for incorporating orthoses into the care of older adults with this condition.
Benefits for Participants
While the study focuses on research, participants may also experience direct benefits, such as:
* Improved posture and comfort while moving.
* Increased awareness of their physical health and function.
* Access to state-of-the-art assessments and expert support throughout the study.
How Will Results Be Used?
The findings will inform healthcare providers about the potential benefits of using spinal braces for older adults with hyperkyphosis. If successful, this research could lead to:
* Better treatment plans for patients.
* Increased availability of braces tailored for older adults.
* Improved quality of life for people living with hyperkyphosis.
Key Takeaways for Patients and Families
* Hyperkyphosis is a manageable condition, and this study explores a promising new way to support mobility and independence.
* Participation involves wearing a brace during regular daily activities and attending two comprehensive evaluations.
* The study is safe, non-invasive, and designed to minimize disruptions to daily life.
This research offers an exciting opportunity to improve care for older adults with hyperkyphosis. By understanding how braces affect movement and strength, healthcare providers can develop better tools and strategies to support aging populations. Families and caregivers can also benefit from knowing there are new, evidence-based options to help their loved ones stay active and independent.