Treatment of Osteoarthritis With Autologous, Microfragmented Adipose Tissue.

NCT03771989 | Unknown DMC

• 1 other identifier: TOMAT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• KOOS4

  The Knee injury and Osteoarthritis Outcome Score. The KOOS questionnaire was developed in the 1990s as an instrument to assess the patient's opinion about their knee and associated problems. Since the first publication in 1998, the psychometric properties of the KOOS have been assessed in more than twenty individual studies from all over the world. Furthermore, KOOS has been evaluated and compared to other instruments in several reviews measured after one year19,20 ,21,22. KOOS4 constructs an average score for four out of the five KOOS subscale scores. It was first used by Frobell et al in 201023. The reason for not including all five subscale scores is that in active patients, very few difficulties with activities of daily living (ADL) exists. Including the subscale ADL would then add unwanted 'noise' to the constructed outcome22.

  6 months

Secondary Outcomes (6)

• KOOS

  6 months

• KOOS

  12 months

• KOOS

  24 months

• Failure

  6 months

• Failure

  12 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Patients are treated with an intra articular injection with autologous, micro-fragmented adipose tissue.

Biological: autologous, micro-fragmented adipose tissue

Control

PLACEBO COMPARATOR

Patients are treated with an intra articular injection with saline (placebo).

Other: Saline

Interventions

autologous, micro-fragmented adipose tissue BIOLOGICAL

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.

Intervention

Saline OTHER

The placebo is an injection with saline

Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years.
• Kellgren-Lawrence grade 2 - 3 in the tibiofemoral joint
• The patient must be expected to be able to attend follow up examinations
• The patient must be able to speak and understand Danish
• The patient must be able to give informed consent

You may not qualify if:

• Smoking (the patient must consent to being non-smoking 6 weeks pre and post the procedure)
• Varus or valgus malalignment of the knee \> 5 degrees
• Laxity of the MCL or LCL of 10 degrees or more compared to the opposite knee
• Knee instability and anterior-posterior laxity of 3mm or above
• Preceding open surgery to the knee or fracture in the proximal tibia or distal femur
• Extension deficit of the knee
• Kellgren-Lawrence grade 4 in any of the three compartments
• BMI \> 40
• Terminal illness or severe medical illness: ASA score higher than or equal to 3

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Copenhagen University Hospital Hvidovre

Hvidovre, 2650, Denmark

Location

Related Publications (1)

• Barfod KW, Blond L, Mikkelsen RK, Bagge J, Holmich LR, Kallemose T, Troelsen A, Holmich P. Treatment of knee osteoarthritis with a single injection of autologous micro-fragmented adipose tissue is not superior to a placebo saline injection: a blinded randomised controlled trial with 2-year follow-up. Br J Sports Med. 2025 Aug 26;59(17):1219-1227. doi: 10.1136/bjsports-2024-108732.

  PMID: 40101939 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kristoffer W Barfod

  Copenhagen University Hospital Hviovre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 4.4.1 Randomization Randomization is computer based, performed in blocks of twelve. 4.4.2 Blinding Blinding of the patient is secured as follows: The liposuction and microfragmentation of the fatty tissue is performed in the operating theatre. When the graft is ready for use the randomization envelope is opened by the project nurse; if the patient is allocated to active treatment syringes containing the microfragmented fatty tissue are prepared; if the patient is allocated to placebo syringes containing saline are prepared. The 10ml syringe is placed in the hand of the treating surgeon. Injection is performed with a 21G cannula. Due to the difference in viscosity of the graft and saline, the surgeon cannot be blinded. In order to investigate if the blinding is working the patients will be asked at 6 months follow up which group he/she believe he/she was assigned to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD PhD

Model Details: The study is performed as 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).

Study Record Dates

• First Submitted: December 9, 2018
• First Posted: December 11, 2018
• Study Start: January 1, 2019
• Primary Completion: February 28, 2022
• Study Completion: March 30, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

DK (1)