Orthobiological Therapies in Musculoskeletal Disorders

Official title

Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions

Overview

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

• Biological PRP injection
  Obtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.
• Biological Bone Marrow Concentrate (BMAC)
  Bone marrow aspirate, rich in mesenchymal stem cells and progenitor cells for tissue repair.
• Biological Hyaluronic Acid (Viscosupplementation)
  Used for joint lubrication and cartilage protection, very common in osteoarthritis.
• Biological Nanofat
  It is an even more refined and liquefied form of processed fat, used primarily for high-precision tissue repair.

Primary outcome measures

• Pain scale [Time frame: From registration until six months, one year, and two years. Two years is the final follow-up period.]
• Joint function [Time frame: Assessment at six months, one year, and two years. The total follow-up period is two years.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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 39222330
• 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. PMID 39751394
• 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. d PMID 30300216

Identifiers

NCT: NCT07434115 · 8.064.745 · Own financing

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗