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NCT Number: NCT05747469

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Osteoarthritis Hand

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

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:

  • To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand

a. To determine safety, the investigators will evaluate for any adverse reactions to the injection at each of the follow up time-points

  • To determine the efficacy of the technique as measured by clinical outcomes in terms of pain, disability, range of motion and strength

a. 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

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

local anaesthetic injection

Drug

Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.

Other names: Lidocaine

Human Adipose Allograft

Procedure

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

Primary outcomes

  1. Range of Motion

    Time frame: Pre-procedure

    Measured with a standardized goniometer

  2. Range of Motion

    Time frame: 6 weeks

    Measured with a standardized goniometer

  3. Range of Motion

    Time frame: 6 month

    Measured with a standardized goniometer

  4. Range of Motion

    Time frame: 12 months

    Measured with a standardized goniometer

  5. Strength Measures

    Time frame: Pre-procedure

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

  6. Strength Measures

    Time frame: 6 weeks

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

  7. Strength Measures

    Time frame: 6 months

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

  8. Strength Measures

    Time frame: 12 months

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

  9. Pain scale scores

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

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

  13. Disability Measurement

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Incidence of Adverse Events

    Time frame: 0-12 months

    Recording of adverse events

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Collaborators

  • Musculoskeletal Transplant Foundation

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 28, 2023
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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