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Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand

Sponsor
Cedars-Sinai Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05747469
Collaborator
Musculoskeletal Transplant Foundation (Other)
20
Enrollment
1
Arm
10.1
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The purpose the research is to evaluate the safety and efficacy of injection of adipose allograft matrix (AAM) to the small joints of the hand for treatment of early stage osteoarthritis. The hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options with autologous fat transfer.

As standard of care, routine strength, pain scale scores (VAS) and range of motion will be recorded, a baseline disability survey (DASH score) will also be administered. After these have all been recorded and administered in a separate visit the patient will undergo the lipofilling procedure.

The subject population will include patients over the age of 18 who present with joint pain of the hand with radiographic evidence of osteoarthritis.

Condition or Disease Intervention/Treatment Phase
  • Drug: local anaesthetic injection
  • Procedure: Human Adipose Allograft
 Early Phase 1

Detailed Description

The investigators central hypothesis is that use of AAM injected directly into the joint will show improvements in pain and disability while providing a safe, off-the-shelf alternative which can obviate the need for, and risks associated with, current treatment options. The overall aim of the project is to validate the clinical use of AAM for the treatment of early-stage osteoarthritis of the hand in adult patients (>18 years of age). The specific aims for this project are:

  1. To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand
  1. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points
  1. To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength
  1. To determine efficacy, the investigators will measure visual analogue pain scale scores as measures by visual analogue scale, disability scores as measured with DASH scores, and standardized range of motion and strengths scores as measured by the same study administrator at each of the follow up time points
  1. To determine patient satisfaction with the procedure a. To determine patient satisfaction, the investigators will administer a survey at each of the follow up time points

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
Anticipated Study Start Date :
Mar 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Adipose Allograft Matrix (AAM)

Using fluoroscopic guidance (X-ray), a needle will be injected into the joint space. 1 cc of Leneva (adipose allograft matrix, MTF Biologics) will be injected into the joint.

Drug: local anaesthetic injection
Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
Other Names:
  • Lidocaine

    • Procedure: Human Adipose Allograft
    Light axial traction of the digit is used to open the joint space when introducing the 18-gauge needle. Fluoroscopy is used to assist with visualization 1 cc of Leneva is injected into the CMC joint and 0.5 cc in the IP, PIP and DIP joints. The puncture is dressed with a band-aid and coban wrap, which will be worn for 48 hours. Return to work and normal use of the hand is recommended at 48 hours. No narcotics are prescribed.
    Other Names:
  • Leneva

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Range of Motion [Pre-procedure]

      Measured with a standardized goniometer

    2. Range of Motion [6 weeks]

      Measured with a standardized goniometer

    3. Range of Motion [6 month]

      Measured with a standardized goniometer

    4. Range of Motion [12 months]

      Measured with a standardized goniometer

    5. Strength Measures [Pre-procedure]

      Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)

    6. Strength Measures [6 weeks]

      Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

    7. Strength Measures [6 months]

      Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

    8. Strength Measures [12 months]

      Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)

    9. Pain scale scores [Pre-procedure]

      Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

    10. Pain scale scores [6 weeks]

      Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

    11. Pain scale scores [6 months]

      Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

    12. Pain scale scores [12 months]

      Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)

    13. Disability Measurement [Pre-procedure]

      DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

    14. Disability Measurement [6 weeks]

      DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

    15. Disability Measurement [6 months]

      DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

    16. Disability Measurement [12 months]

      DASH (Disability of the Arm, Shoulder and Hand) score The DASH is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability). This score was designed be useful in patients with any musculoskeletal disorder of the upper limb.

    17. Patient satisfaction [Day of procedure]

      Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.

    18. Patient satisfaction [6 weeks]

      Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") " for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.

    19. Patient satisfaction [6 months]

      Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.

    20. Patient satisfaction [12 months]

      Five-point Likert scale (from 1 "strong disagree" to 5 "strongly agree") for the following two survey points: Satisfaction of patient with the procedure and would the patient recommend this procedure to others.

    Secondary Outcome Measures

    1. Incidence of Adverse Events [0-12 months]

      Recording of adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Patients greater than 18 years, with presentation to the Cedars Sinai hand clinic for joint pain of the hand carpometacarpal, interphalangeal, proximal interphalangeal, and distal interphalangeal joints (CMC, IP, PIP or DIP joints).

    • Radiographic evidence of osteoarthritis.

    Exclusion Criteria:

    • Prior intervention for the presenting joint (either in the form of cortisone or hyaluronic acid injection or surgery).

    • Rheumatoid or other inflammatory arthritis condition

    • Collagen vascular disease

    • Pregnancy or breast-feeding

    • Congestive heart failure

    • Chronic obstructive pulmonary disease

    • Chronic renal failure

    • Those who had medication or oral supplements for the previous 4 weeks that could prolong bleeding time (e.g.; Aspirin, Plavix).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cedars-Sinai Medical Center
    • Musculoskeletal Transplant Foundation

    Investigators

    • Principal Investigator: Meghan McCullough, MD, Cedars-Sinai Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Meghan McCullough, MD, Principal Investigator, Cedars-Sinai Medical Center
    ClinicalTrials.gov Identifier:
    NCT05747469
    Other Study ID Numbers:
    • STUDY00002134
    First Posted:
    Feb 28, 2023
    Last Update Posted:
    Mar 7, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Arthritis
    Osteoarthritis
    Lidocaine
    Anesthetics, Local
    Anesthetics

    Study Results

    No Results Posted as of Mar 7, 2023