Orthobiological Therapies in Musculoskeletal Disorders

ConditionMusculoskeletal Diseases or Conditions

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorPROREGEN

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: Use of orthobiological products in musculoskeletal conditions.Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

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".

Time frame

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

Time frame

Assessment at six months, one year, and two years. The total follow-up period is two years.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

PROREGEN

Lead sponsor

Centro Universitário Univates

Collaborator

Source ClinicalTrials.gov

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