PRP injection
BiologicalObtained by centrifuging blood, it concentrates platelets and growth factors for regeneration.
NCT Number: NCT07434115
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Early Phase 1
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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".
Time frame: 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
Total score for the pain subscale:
0 to 20 points
PROREGEN
Network
Clinical and Functional Evaluation of Orthobiological Therapies in Musculoskeletal Conditions
Acronym: PROREGEN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07606092
ACL Surgery, Achilles Tendon Surgery
View Trial DetailsNCT07555184
Achilles Tendinopathy (AT), Adherence
Blackburn, United Kingdom
View Trial DetailsNCT07700017
Musculoskeletal Diseases, Musculoskeletal Diseases or Conditions
Vienna, Austria
View Trial DetailsNCT06594120
Musculoskeletal Diseases, Musculoskeletal Diseases or Conditions
Bad Hofgastein, State of Salzburg, Austria
View Trial Details