Knee Arthritis Treatment With Autologous Fragmented Adipose Tissue and PRP - Comparison of Two Treatment Methods

NCT04321629 | Unknown Phase 2

• 1 other identifier: RSC_PBAK_2018_V3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, randomized, controlled study. The purpose of this study is to assess functional and clinical changes among patients with symptomatic knee OA treated with intra-articular injections of autologous adipose tissue or PRP and to compare the efficacy of both therapeutic methods. We hypothesize that adipose tissue injections will improve patients' quality of life and functional status and will decrease pain level significantly more than PRP injections. In addition to the functional tests and muscle strength measurement, the patient reported outcome measures (PROMs) of the knee joint function and quality of life will be used to assess each participant. The same inclusion criteria have been established for an Experimental Group (subjects treated with autologous fat tissue) and a Control Group (subjects treated with PRP). Those criteria consist of: symptomatic knee OA, age between 45 and 65 y.o., Kellgren- Lawrence grades I - III OA, no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections). Those patients who meet inclusion criteria will be allocated to Fat Tissue Group or PRP Group randomly. Patients will be assessed five times: before treatment and 1, 3, 6 and 12 months after the treatment. The PROMs consist of the four questionnaires: The Knee injury and Osteoarthritis Outcome Score (KOOS), International Knee Documentation Committee 2000 (IKDC 2000), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (21,22), the Health Questionnaire EQ- 5D- 5L. Moreover, three functional tests will be performed to assess patient's functional status: The Timed Up and Go Test (TUG), The 5 Times Sit to Stand Test (5xSTS), The 10m Walk Test (10mWT). To assess strength parameters of the knee flexors and extensors the Maximal Voluntary Isometric Contraction (MVIC) will be measured. Each test will be supervised by the same one physiotherapist to avoid any interexaminer bias and discrepancies during testing.

Conditions

Osteo Arthritis Knee; Knee Osteoarthritis; Knee Pain Chronic; Knee Arthritis; Knee Disease; Knee Pain Swelling; Joint Diseases

Keywords

knee; arthritis; prp; msc; fat transfer; adipose tissue

Outcome Measures

Primary Outcomes (7)

• Change in The Knee injury and Osteoarthritis Outcome Score (KOOS)

  The answers are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated.

  1, 3, 6 and 12 months after the treatment

• Change in the International Knee Documentation Committee 2000 (IKDC 2000) score

  The IKDC contains sections on knee symptoms (7 items), function (2 items), and sports activities (2 items). Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

  1, 3, 6 and 12 months after the treatment

• Change in tthe Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score

  Due to no polish version of the WOMAC score, it will be calculated from KOOS score. Higher scores represent worse pain, stiffness, and functional limitations.

  1, 3, 6 and 12 months after the treatment

• Change in the quality of life score (EQ- 5D- 5L)

  The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. Scores range from 5 points (highest level of function and lowest level of symptoms) to 25 points (lowest level of function or highest level of symptoms).

  1, 3, 6 and 12 months after the treatment

• Change in functional status according to The Timed Up and Go Test (TUG)

  The result of this test is time measured with stopwatch. Time limit for this test is 3 minutes 30 seconds. Less time means better result.

  1, 3, 6 and 12 months after the treatment

• Change in functional status according to The 5 Times Sit to Stand Test (5xSTS)

  The result of this test is time measured with stopwatch. The stopwatch is stopped when the subject sits down after the fifth repetition. Less time means better result.

  1, 3, 6 and 12 months after the treatment

• Change in functional status according to The 10m Walk Test (10mWT)

  The result of this test is time measured with stopwatch. The patient is not allowed to run but may use the crutches or a walker if needed. Less time means better result.

  1, 3, 6 and 12 months after the treatment

Secondary Outcomes (1)

• Strength parameters

  1, 3, 6 and 12 months after the treatment

Study Arms (2)

Autologous Fat Tissue Group

EXPERIMENTAL

Group of patients treated with intra-articular injections of autologous adipose tissue.

Combination Product: autologous adipose tissue transfer

PRP Group

ACTIVE COMPARATOR

Group of patients treated with intra-articular injections of platelet-rich-plasma.

Combination Product: PRP injections

Interventions

autologous adipose tissue transfer COMBINATION_PRODUCT

experimental group: liposuction, adipose tissue preparation and intra-articular injection

Autologous Fat Tissue Group

PRP injections COMBINATION_PRODUCT

control group: blood collection, blood preparation and intra-articular PRP injection

PRP Group

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• symptomatic knee OA
• Kellgren- Lawrence grades I - III OA
• no or minimal positive effects of previous conservative treatment (rehabilitation, hyaluronic acid injections, steroid injections)
• VAS pain level minimum 4 in one knee, VAS pain \< 2 in the contralateral knee

You may not qualify if:

• Use of local corticosteroids up to three months or hyaluronic acid injections up to six months prior to the study
• Past or present joint infection
• Previous knee arthroscopy surgery up to one year prior to examination
• Peripheral inflammatory diseases (rheumatoid arthritis, spondyloarthropathies, etc.)
• Total arthroplasty and osteotomy
• Ankylosis of the joint
• Dermatitis or dermatological disease at the intended injection site
• Coexistence of degenerative changes in other limb joints (hip, foot)
• Cancer
• Oral corticosteroid therapy
• Use of medicines that affect blood clotting
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Rehasport Clinic: lead

Study Sites (1)

Rehasport

Poznan, Wielkopolska, 60201, Poland

RECRUITING

Related Publications (1)

• Bakowski P, Kaszynski J, Walecka J, Ciemniewska-Gorzela K, Bakowska-Zywicka K, Piontek T. Autologous adipose tissue injection versus platelet-rich plasma (PRP) injection in the treatment of knee osteoarthritis: a randomized, controlled study - study protocol. BMC Musculoskelet Disord. 2020 May 20;21(1):314. doi: 10.1186/s12891-020-03345-8.

  PMID: 32434498 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Arthritis; Insomnia, Fatal Familial

Condition Hierarchy (Ancestors)

Osteoarthritis; Musculoskeletal Diseases; Rheumatic Diseases; Prion Diseases; Central Nervous System Infections; Infections; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders

Study Officials

• Pawel Bakowski, MD PhD

  Rehasport Clinic

  PRINCIPAL INVESTIGATOR

• Tomasz Piontek, MD PhD

  Rehasport Clinic

  STUDY CHAIR

Central Study Contacts

Pawel Bakowski, MD PhD

CONTACT

0048504759624; pawel.bakowski@o2.pl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 25, 2020
• Study Start: July 30, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: March 25, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)