Health TrialsbyHealthPanel

Optimal Articular Solutions With Intraosseous and Synovial Platelet-Rich Plasma

ConditionKnee Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorUniversidade do Porto

About this trial

This is a prospective cohort clinical study. Due to logistic constraints at the sites of implementation, a randomized allocation will not be feasible (private clinic). Patients will be selected with the aim of matching for important confounders (sex and age) the grade of knee OA will be restricted to advance stages.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult individuals with unilateral or bilateral symptomatic knee OA diagnosis according to the American College of Rheumatology

with symptoms for more than 3 months

confirmed with radiologic diagnosis (Kellgren-Lawrence grades III or IV).

Patients must be able to walk with a painful knee.

Disqualifiers

previous history of knee surgery

systemic autoimmune or rheumatic disease

platelet diseases

use of NSAIDs 3 days prior the injections

Trial design

Design model

Parallel

Treatments tested in this trial

  • Platelet rich-plasma - PRP - intraosseous and intra-articular admnistration

    Combination product

    Group 1 will receive two intraosseous injections of PRP and a subsequent/synchronous intra-articular injection of PRP on the same day. Group 2 will only receive two intra-articular injections of PRP, separated by one week.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Intraosseous and intra-articular PRPActive comparator 1 intervention
Group B: Intra-articular PRPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PROM - Knee related Qol

Knee injury and Osteoarthritis Outcome Score (KOOS) - absolute value from the score (units). Min-Max (0-100) higher scores indicate better outcomes and a higher quality of life related to the knee

Time frame
baseline, and at follow-up of 3 months, 6 months and 12 months
2

PROM - PAIN

Visual analogic Score - PAIN (VAS) -absolute value from the score (units). Min-Max (0-10) higher scores indicate worse outcomes

Time frame
baseline, and at follow-up of 3 months, 6 months and 12 months

Secondary outcomes

1

bone marrow edema -MRI

first scored dichotomous (yes/no)

Time frame
1 month prior to the injection; 1 month to one year after intervention
2

bone marrow edema -MRI

BME will be classified using the criteria defined in the Whole-Organ Magnetic Resonance Imaging Score (WORMS). Range 0-3 Higher scores mean more medular edema.

Time frame
1 month prior to the injection; 1 month to one year after intervention

Other outcomes

Sponsors and contacts

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

Universidade do Porto

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: