Osteoarthritis HandEarly Phase 1NCT05747469
Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
A Early Phase 1 study testing local anaesthetic injection and Human Adipose Allograft in people with Osteoarthritis Hand, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis Hand
- What is being tested?
- local anaesthetic injection and Human Adipose Allograft
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2023to 1 Jan 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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:
- To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand
- 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
- 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
- Conditions
- Osteoarthritis Hand
- Being tested
- local anaesthetic injection, Human Adipose Allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local anaesthetic injectionDrug
Also called Lidocaine
Subcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint.
Human Adipose AllograftProcedure or surgery
Also called Leneva
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.
| Study group | Role | What they receive |
|---|---|---|
| Adipose Allograft Matrix (AAM) | Other | 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. Receives: Drug: local anaesthetic injection; Procedure: Human Adipose Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Measured with a standardized goniometer
Measured: Pre-procedure
Range of Motion
Measured with a standardized goniometer
Measured: 6 weeks
Range of Motion
Measured with a standardized goniometer
Measured: 6 month
Range of Motion
Measured with a standardized goniometer
Measured: 12 months
Strength Measures
Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)
Measured: Pre-procedure
Strength Measures
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Measured: 6 weeks
Strength Measures
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Measured: 6 months
Strength Measures
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Measured: 12 months
Pain scale scores
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Measured: Pre-procedure
Pain scale scores
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Measured: 6 weeks
Pain scale scores
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Measured: 6 months
Pain scale scores
Measured using the visual analogue scale (VAS) scored 0 (no pain=better outcome) to 10 (worst pain=worse outcome)
Measured: 12 months
Disability Measurement
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.
Measured: Pre-procedure
Disability Measurement
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.
Measured: 6 weeks
Disability Measurement
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.
Measured: 6 months
Disability Measurement
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.
Measured: 12 months
Patient satisfaction
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.
Measured: Day of procedure
Patient satisfaction
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.
Measured: 6 weeks
Patient satisfaction
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.
Measured: 6 months
Patient satisfaction
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.
Measured: 12 months
Secondary outcomes (1)
Incidence of Adverse Events
Recording of adverse events
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start28 Aug 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis HandStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Responsible party
- Principal investigator, Meghan McCullough, MD, Cedars-Sinai Medical Center
- Investigators
- Meghan McCullough, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747469
- Sponsor's protocol ID
- STUDY00002134
- Status last verified
- Nov 2025
- First submitted
- 5 Feb 2023
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
PubMed 18261664Haas EM, Eisele A, Arnoldi A, Paolini M, Ehrl D, Volkmer E, Giunta RE. One-Year Outcomes of Intraarticular Fat Transplantation for Thumb Carpometacarpal Joint Osteoarthritis: Case Review of 99 Joints. Plast Reconstr Surg. 2020 Jan;145(1):151-159. doi: 10.1097/PRS.0000000000006378.
PubMed 31592943Holland C, Jaeger L, Smentkowski U, Weber B, Otto C. Septic and aseptic complications of corticosteroid injections: an assessment of 278 cases reviewed by expert commissions and mediation boards from 2005 to 2009. Dtsch Arztebl Int. 2012 Jun;109(24):425-30. doi: 10.3238/arztebl.2012.0425. Epub 2012 Jun 15.
PubMed 22787504McGarry JG, Daruwalla ZJ. The efficacy, accuracy and complications of corticosteroid injections of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1649-54. doi: 10.1007/s00167-010-1380-1. Epub 2011 Jan 11.
PubMed 21222099Buck-Gramcko D. [Denervation of the wrist joint and interphalageal joints]. Handchirurgie. 1969;1(4):179-81. No abstract available. German.
PubMed 5409431Lucht U, Vang PS, Munck J. Soft tissue interposition arthroplasty for osteoarthritis of the carpometacarpal joint of the thumb. Acta Orthop Scand. 1980 Oct;51(5):767-71. doi: 10.3109/17453678008990872.
PubMed 7468170Deb R, Sauerbier M, Rauschmann MA. [History of arthroplasty for finger joints]. Orthopade. 2003 Sep;32(9):770-8. doi: 10.1007/s00132-003-0518-y. German.
PubMed 14508641Bruser P. [Modified volar plate arthroplasty for posttraumatic and idiopathic osteoarthritis of the metacarpophalangeal and proximal interphalangeal joints]. Orthopade. 2008 Dec;37(12):1180-6. doi: 10.1007/s00132-008-1324-3. German.
PubMed 18972098Swanson AB. Disabling arthritis at the base of the thumb: treatment by resection of the trapezium and flexible (silicone) implant arthroplasty. J Bone Joint Surg Am. 1972 Apr;54(3):456-71. No abstract available.
PubMed 5055148Swanson AB. Flexible implant arthroplasty for arthritic finger joints: rationale, technique, and results of treatment. J Bone Joint Surg Am. 1972 Apr;54(3):435-55. No abstract available.
PubMed 5055146Heers G, Grifka J, Borisch N. [First results after implantation of a pyrocarbon-endoprosthesis in patients with degenerative arthritis]. Z Orthop Ihre Grenzgeb. 2006 Nov-Dec;144(6):609-13. doi: 10.1055/s-2006-955189. German.
PubMed 17187336IJsselstein CB, van Egmond DB, Hovius SE, van der Meulen JC. Results of small-joint arthrodesis: comparison of Kirschner wire fixation with tension band wire technique. J Hand Surg Am. 1992 Sep;17(5):952-6. doi: 10.1016/0363-5023(92)90476-6.
PubMed 1401814Herold C, Rennekampff HO, Groddeck R, Allert S. Autologous Fat Transfer for Thumb Carpometacarpal Joint Osteoarthritis: A Prospective Study. Plast Reconstr Surg. 2017 Aug;140(2):327-335. doi: 10.1097/PRS.0000000000003510.
PubMed 28369017Damia E, Chicharro D, Lopez S, Cuervo B, Rubio M, Sopena JJ, Vilar JM, Carrillo JM. Adipose-Derived Mesenchymal Stem Cells: Are They a Good Therapeutic Strategy for Osteoarthritis? Int J Mol Sci. 2018 Jun 30;19(7):1926. doi: 10.3390/ijms19071926.
PubMed 29966351Black LL, Gaynor J, Adams C, Dhupa S, Sams AE, Taylor R, Harman S, Gingerich DA, Harman R. Effect of intraarticular injection of autologous adipose-derived mesenchymal stem and regenerative cells on clinical signs of chronic osteoarthritis of the elbow joint in dogs. Vet Ther. 2008 Fall;9(3):192-200.
PubMed 19003780
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Allograft Adipose Matrix for Small Joint Arthritis of the Hand
- ClinicalTrials.gov ID
- NCT05747469
- Acronym / sponsor ID
- STUDY00002134
- Conditions
- Osteoarthritis Hand
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Collaborators
- Musculoskeletal Transplant Foundation
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To determine the safety of use of Leneva as a lipofilling alternative to autologous fat grafting for arthritis of the hand
- 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
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose Allograft Matrix (AAM) | Other | Drug: local anaesthetic injection, Procedure: Human Adipose AllograftUsing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| local anaesthetic injectionAlso: LidocaineSubcutaneous local anesthesia with 1% lidocaine without epinephrine is administered to the skin overlying the joint. | Drug | Adipose Allograft Matrix (AAM) |
| Human Adipose AllograftAlso: LenevaLight 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. | Procedure or surgery | Adipose Allograft Matrix (AAM) |
Primary outcome
Range of Motion
Time frame: Pre-procedure
Measured with a standardized goniometer
Range of Motion
Time frame: 6 weeks
Measured with a standardized goniometer
Range of Motion
Time frame: 6 month
Measured with a standardized goniometer
Range of Motion
Time frame: 12 months
Measured with a standardized goniometer
Strength Measures
Time frame: Pre-procedure
Strength to grip, key pinch and tip pinch, as measured by Jamar dynamometer device)
Strength Measures
Time frame: 6 weeks
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Strength Measures
Time frame: 6 months
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
Strength Measures
Time frame: 12 months
Strength to grip, key pinch and tip pinch (as measured by Jamar dynamometer device)
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)
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)
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)
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)
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.
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.
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.
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.
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.
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.
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.
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.
1 secondary outcome
Incidence of Adverse Events
Time frame: 0-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 18261664Heyworth BE, Lee JH, Kim PD, Lipton CB, Strauch RJ, Rosenwasser MP. Hylan versus corticosteroid versus placebo for treatment of basal joint arthritis: a prospective, randomized, double-blinded clinical trial. J Hand Surg Am. 2008 Jan;33(1):40-8. doi: 10.1016/j.jhsa.2007.10.009.
- Background: PubMed 31592943Haas EM, Eisele A, Arnoldi A, Paolini M, Ehrl D, Volkmer E, Giunta RE. One-Year Outcomes of Intraarticular Fat Transplantation for Thumb Carpometacarpal Joint Osteoarthritis: Case Review of 99 Joints. Plast Reconstr Surg. 2020 Jan;145(1):151-159. doi: 10.1097/PRS.0000000000006378.
- Background: PubMed 22787504Holland C, Jaeger L, Smentkowski U, Weber B, Otto C. Septic and aseptic complications of corticosteroid injections: an assessment of 278 cases reviewed by expert commissions and mediation boards from 2005 to 2009. Dtsch Arztebl Int. 2012 Jun;109(24):425-30. doi: 10.3238/arztebl.2012.0425. Epub 2012 Jun 15.
- Background: PubMed 21222099McGarry JG, Daruwalla ZJ. The efficacy, accuracy and complications of corticosteroid injections of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2011 Oct;19(10):1649-54. doi: 10.1007/s00167-010-1380-1. Epub 2011 Jan 11.
- Background: PubMed 5409431Buck-Gramcko D. [Denervation of the wrist joint and interphalageal joints]. Handchirurgie. 1969;1(4):179-81. No abstract available. German.
- Background: PubMed 7468170Lucht U, Vang PS, Munck J. Soft tissue interposition arthroplasty for osteoarthritis of the carpometacarpal joint of the thumb. Acta Orthop Scand. 1980 Oct;51(5):767-71. doi: 10.3109/17453678008990872.
- Background: PubMed 14508641Deb R, Sauerbier M, Rauschmann MA. [History of arthroplasty for finger joints]. Orthopade. 2003 Sep;32(9):770-8. doi: 10.1007/s00132-003-0518-y. German.
- Background: PubMed 18972098Bruser P. [Modified volar plate arthroplasty for posttraumatic and idiopathic osteoarthritis of the metacarpophalangeal and proximal interphalangeal joints]. Orthopade. 2008 Dec;37(12):1180-6. doi: 10.1007/s00132-008-1324-3. German.
- Background: PubMed 5055148Swanson AB. Disabling arthritis at the base of the thumb: treatment by resection of the trapezium and flexible (silicone) implant arthroplasty. J Bone Joint Surg Am. 1972 Apr;54(3):456-71. No abstract available.
- Background: PubMed 5055146Swanson AB. Flexible implant arthroplasty for arthritic finger joints: rationale, technique, and results of treatment. J Bone Joint Surg Am. 1972 Apr;54(3):435-55. No abstract available.
- Background: PubMed 17187336Heers G, Grifka J, Borisch N. [First results after implantation of a pyrocarbon-endoprosthesis in patients with degenerative arthritis]. Z Orthop Ihre Grenzgeb. 2006 Nov-Dec;144(6):609-13. doi: 10.1055/s-2006-955189. German.
- Background: PubMed 1401814IJsselstein CB, van Egmond DB, Hovius SE, van der Meulen JC. Results of small-joint arthrodesis: comparison of Kirschner wire fixation with tension band wire technique. J Hand Surg Am. 1992 Sep;17(5):952-6. doi: 10.1016/0363-5023(92)90476-6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan McCullough, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing local anaesthetic injection and Human Adipose Allograft in people with Osteoarthritis Hand, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: Pre-procedure). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05747469, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.