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Treatment of Osteoarthritis With Autologous, Microfragmented Adipose Tissue.

NCT03771989 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2023-09-22

No results posted yet for this study

Summary

The study is a blinded, multicenter, randomized, controlled trial with participants individually randomized to one of two parallel groups:

1. The intervention group: Participants receive one intra articular injection with autologous, microfragmented adipose tissue.
2. The control group: Participants receive one intra articular injection with Saline (placebo).

The objective of the study is to investigate if intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system affects the patient reported outcome in patients with osteoarthritis of the knee.

The primary endpoint is KOOS4 evaluated at 6 months after the intervention. Secondary endpoints are the KOOS including all five subscales evaluated after 6months, 1 and 2 years.

Conditions

  • Osteoarthritis, Knee

Interventions

BIOLOGICAL

autologous, micro-fragmented adipose tissue

The active treatment is an intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system. Implantation of the graft is performed with the patient supine using two injections sites in order to reduce the risk of extra-articular injection.

OTHER

Saline

The placebo is an injection with saline

Sponsors & Collaborators

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • Kristoffer W Barfod · Copenhagen University Hospital Hviovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-02-28
Completion
2024-03-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03771989 on ClinicalTrials.gov