Orthobiological Therapies in Musculoskeletal Disorders
PROREGEN
Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions
2 other identifiers
interventional
300
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2026
Longer than P75 for early_phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2026
CompletedStudy Start
First participant enrolled
January 30, 2026
CompletedFirst Posted
Study publicly available on registry
February 25, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2030
February 25, 2026
February 1, 2026
2.9 years
January 28, 2026
February 19, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 1. = mild pain 2. = moderate pain 3. = severe pain 4. = extreme 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.
Study Arms (1)
Use of orthobiological products in musculoskeletal conditions.
EXPERIMENTALAfter an evaluation by a medical professional, the patient will be advised on the best orthobiological treatment for their case.
Interventions
Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.
Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair.
Used for joint lubrication and cartilage protection, very common in osteoarthritis.
It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PROREGENlead
- Centro Universitário Univatescollaborator
Related Publications (3)
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.
PMID: 39222330BACKGROUNDBensa 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.
PMID: 39751394BACKGROUNDChu 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.
PMID: 30300216BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2026
First Posted
February 25, 2026
Study Start
January 30, 2026
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2030
Last Updated
February 25, 2026
Record last verified: 2026-02