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| ID | Type | Description | Link |
|---|---|---|---|
| Own financing | Other Identifier | PROREGEN |
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| Name | Class |
|---|---|
| Centro Universitário Univates | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Use of orthobiological products in musculoskeletal conditions. | Experimental | After an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP injection | Biological | Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Pain scale | 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". | From registration until six months, one year, and two years. Two years is the final follow-up period. |
| Joint function | 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
Total score for the pain subscale: 0 to 20 points | Assessment at six months, one year, and two years. The total follow-up period is two years. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39222330 | Background | Winkler T, Geissler S, Maleitzke T, Perka C, Duda GN, Hildebrandt A. Advanced therapies in orthopaedics. EFORT Open Rev. 2024 Sep 2;9(9):837-844. doi: 10.1530/EOR-24-0084. | |
| 39751394 | Background | Bensa A, Previtali D, Sangiorgio A, Boffa A, Salerno M, Filardo G. PRP Injections for the Treatment of Knee Osteoarthritis: The Improvement Is Clinically Significant and Influenced by Platelet Concentration: A Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2025 Mar;53(3):745-754. doi: 10.1177/03635465241246524. Epub 2025 Jan 3. |
| Label | URL |
|---|---|
| The WHO emphasizes the need for studies with rigorous methodology and ethical principles to validate the safety and efficacy of new therapies. The use of orthobiologics is encouraged only when based on solid evidence of efficacy. | View source |
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We cannot yet provide this information, as the study involves a larger team.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Nov 28, 2025 | Jan 28, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D055676 | Viscosupplementation |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D007270 | Injections, Intra-Articular |
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| Bone Marrow Concentrate (BMAC) | Biological | Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair. |
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| Hyaluronic Acid (Viscosupplementation) | Biological | Used for joint lubrication and cartilage protection, very common in osteoarthritis. |
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| Nanofat | Biological | It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair. |
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| 30300216 | Background | Chu CR, Rodeo S, Bhutani N, Goodrich LR, Huard J, Irrgang J, LaPrade RF, Lattermann C, Lu Y, Mandelbaum B, Mao J, McIntyre L, Mishra A, Muschler GF, Piuzzi NS, Potter H, Spindler K, Tokish JM, Tuan R, Zaslav K, Maloney W. Optimizing Clinical Use of Biologics in Orthopaedic Surgery: Consensus Recommendations From the 2018 AAOS/NIH U-13 Conference. J Am Acad Orthop Surg. 2019 Jan 15;27(2):e50-e63. doi: 10.5435/JAAOS-D-18-00305. |
| D007267 |
| Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |