Musculoskeletal Diseases or Conditions
Conditions
Brief summary
To evaluate the clinical and functional effects of using orthobiological therapies (hyaluronic acid, platelet-rich plasma, bone marrow aspirate, nanofat, among others) in the treatment of various musculoskeletal diseases in patients routinely treated at the Proregen Medical Clinic and its affiliates. The sample will consist of adult patients (≥18 years), of both sexes, with different musculoskeletal diagnoses involving joints, tendons, ligaments, cartilage or bone, among others.
Detailed description
Orthobiological therapies, such as hyaluronic acid, platelet-rich plasma, bone marrow aspirate concentrate, and adipose tissue derivatives, have been widely used in the management of musculoskeletal pathologies, including tendinopathies, osteoarthritis, and delayed bone consolidation. However, scientific evidence is still limited by the heterogeneity of protocols, populations, and evaluation methods. This umbrella project aims to prospectively record and analyze the clinical and functional outcomes associated with the use of these therapies in patients treated according to institutional medical indications. Participants with different osteoarticular pathologies undergoing routine orthobiological treatment at the Proregen Medical Clinic and its affiliates will be included. The central hypotheses of the study are that orthobiological therapies present measurable clinical benefits in terms of pain, function, and quality of life in various osteoarticular indications; that the safety of these approaches is adequate when performed under defined clinical criteria; and that it is possible to identify patterns of greater efficacy according to the type of orthobiological agent, the pathology, and the follow-up time. As an expected conclusion, the study aims to generate real clinical data that can serve as a basis for derivative studies, in addition to contributing to the standardization and rationalization of the use of orthobiological therapies in orthopedic practice.
Interventions
BIOLOGICALPRP injection
Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.
BIOLOGICALBone Marrow Concentrate (BMAC)
Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair.
BIOLOGICALHyaluronic Acid (Viscosupplementation)
Used for joint lubrication and cartilage protection, very common in osteoarthritis.
BIOLOGICALNanofat
It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair.
Sponsors
PROREGEN
Centro Universitário Univates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older; * Clinical and/or radiological diagnosis of an eligible musculoskeletal condition; * Formal clinical indication for treatment with orthobiological agents, according to routine care; * Regular access to the WhatsApp application, ensuring the necessary communication for sending and receiving digital questionnaires and other study instructions; * Ability to understand the study and sign the Informed Consent Form.
Exclusion criteria
* Medical contraindication to the use of orthobiologics (e.g., active infection, severe hematological diseases, active cancer); * Recent use (≤3 months) of orthobiologic therapies in the same area to be treated; * Pregnant or breastfeeding women; * Cognitive or psychiatric diseases that prevent adequate clinical follow-up; * Simultaneous participation in another interventional clinical study with the same therapeutic purpose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain scale | From registration until six months, one year, and two years. Two years is the final follow-up period. | Changes in pain scores six months after treatment with orthobiological materials. The following scale will be used: VAS - Visual Analog Scale (0 to 10 cm): The patient marks, with a line or dot, the location on the line that best represents the pain they are feeling at that moment. 0 cm → "no pain" / 10 cm → "worst pain imaginable". |
| Joint function | Assessment at six months, one year, and two years. The total follow-up period is two years. | Changes observed in joint function in patients who received orthobiological treatment after 6 months. The following scales will be used: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index): is a questionnaire specific to osteoarthritis, widely validated and used in clinical research. It assesses symptoms and functional impact of osteoarthritis. The WOMAC consists of 24 items, divided into 3 subscales: Pain - 5 items Stiffness - 2 items Physical function - 17 items Scoring is as follows: 0 = no pain 1. = mild pain 2. = moderate pain 3. = severe pain 4. = extreme pain Total score for the pain subscale: 0 to 20 points |
Countries
Brazil
Contacts
CONTACTGabriela D Daiprai
Outcome results
None listed