Health TrialsbyHealthPanel

The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis

ConditionsOsteoarthritis ShoulderShoulder Pain
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age25-75
SponsorStanford University

About this trial

This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 25 and 75 years-old

Diagnosis of pre-existing osteoarthritis of the glenohumeral joint

Working understanding of the English language and able to fully understand the procedure

Capable of providing informed consent

Disqualifiers

Age < 25 or > 75 years old

Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone) osteoarthritis

Prior total or partial joint replacement surgery or surgery involving cartilage regeneration

Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Micro Fragmented Adipose Tissue

    Biological/Vaccine

    Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

  • Corticosteroid injection

    Biological/Vaccine

    Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: MFAT (Micro Fragmented Adipose Tissue)Experimental treatment 1 intervention
Group B: Conventional TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ASES Shoulder Score

Patient reported outcome measure that reports shoulder pain and shoulder functionality

Time frame
24 Months

Secondary outcomes

1

DASH Outcome Measure

Patient reported questionnaire that measures physical function and symptoms

Time frame
24 Months
2

Veterans RAND 12 (VR-12) score

Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy

Time frame
24 Months

Other outcomes

Sponsors and contacts

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

Stanford University

Lead sponsor

Source ClinicalTrials.gov
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