CTM Injection for Thumb Arthritis

(CTM CMC Trial)

Overseen By Lexie Reissaus, B.S., CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana Hand to Shoulder Center

Must not be taking: Narcotics

Disqualifiers: Previous surgery, Pregnancy, Non-English, others

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate post-surgery

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis of the CMC joint.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with chronic narcotic use.

Is CTM injection generally safe for humans?

The safety data for anti-TNF drugs, which may be similar to CTM, show that they are generally well-tolerated but can increase the risk of infections, cardiovascular issues, and neurological problems. These drugs have been used in treating rheumatoid arthritis and have a manageable safety profile, though they require careful monitoring for infections and other potential side effects. ^{1 2 3 4 5}

How does the CTM Injection treatment for thumb arthritis differ from other treatments?

The CTM Injection for thumb arthritis is unique because it involves injecting bone marrow aspirate concentrate (BMAC) directly into the affected joint, which is a novel approach compared to traditional treatments like corticosteroid injections or surgery. This method aims to improve joint function and delay the need for surgery by using the body's own cells to promote healing. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment CTM Injection for Thumb Arthritis?

The study on bone marrow aspirate concentrate (BMAC) injections for thumb arthritis showed that many patients experienced improved quality of life and pain relief, suggesting that similar injection therapies can be effective in managing symptoms and delaying surgery. ^{6 7 11 12 13}

Are You a Good Fit for This Trial?

This trial is for individuals who have had arthroplasty surgery to treat primary osteoarthritis in the thumb's carpometacarpal (CMC) joint. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to follow specific protocols.

Inclusion Criteria

I am having surgery for my thumb base.

I can go back to the Indiana Hand to Shoulder Center for follow-ups.

Patients who can consent to be a part of this study

Exclusion Criteria

I have had surgery before on the base of my thumb on the side that needs operation now.

Chronic narcotic use

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection of CTM or saline after arthroplasty surgery

Immediate post-surgery

Follow-up

Participants are monitored for narcotic use and pain levels postoperatively

6 weeks

Extended Follow-up

Participants are assessed for pain and functional outcomes using VAS and quickDASH

6 months

What Are the Treatments Tested in This Trial?

Interventions

• CTM

Trial Overview The study is testing the effectiveness of a single injection treatment called CTM after CMC thumb joint surgery. Participants will either receive the CTM injection or a placebo to compare outcomes.

How Is the Trial Designed?

Group I: Treatment - CTM Experimental Treatment 1 Intervention

For patients who randomize to CTM: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the CTM Flow material. A 23, or 20 gauge needle will be used to inject the CTM after arthroplasty and prior to closure of the capsule. To draw up the injection: allow the particulate to settle to the bottom and withdrawal fluid into the 3 or 5 cc syringe. It is ok if some particulate is drawn up into the syringe. 2cc of CTM will be injected into each patient.

Group II: Placebo - Saline Placebo Group 1 Intervention

For patients who randomize to Saline: An unblinded IHTSC Fellow, nurse/PA, or OR staff will use a 3 or 5 cc syringe to draw up the saline. A 23 gauge needle will be used to inject the saline after arthroplasty and prior to closure of the capsule. 2cc of saline will be injected into each patient.

Who Is Running the Clinical Trial?

Indiana Hand to Shoulder Center

Lead Sponsor

Trials

9

Recruited

320+

CTM Biomedical

Industry Sponsor

Trials

5

Recruited

200+

Published Research Related to This Trial

A systematic review of 9 randomized controlled trials involving 504 patients found that injection-based therapies for base of thumb osteoarthritis, including corticosteroids and hyaluronic acid, did not show significant superiority over placebo or each other in terms of pain relief and function.

While corticosteroids demonstrated a reduction in pain on activity compared to hyaluronic acid in a limited analysis, overall evidence remains inconclusive, highlighting the need for more robust studies to determine the effectiveness of injection therapies compared to non-injection treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Injection therapy for base of thumb osteoarthritis: a systematic review and meta-analysis. Riley, N., Vella-Baldacchino, M., Thurley, N., et al.[2020]

In a study of 19,120 intra-articular steroid injections for base of thumb osteoarthritis over 19 years, serious complications were very rare, occurring in only 0.04% of cases within 90 days.

About 50% of patients required further procedures, with only 22.4% undergoing surgery, indicating that while injections are common, most patients do not need additional surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. Lane, JCE., Craig, RS., Rees, JL., et al.[2021]

In a study of 239 patients with thumb carpometacarpal arthritis, 59% required a repeat corticosteroid injection and 37.6% eventually underwent surgery, indicating that many patients may need further intervention after initial treatment.

Factors such as advanced arthritis (Eaton stage III/IV), current smoking, and previous hand surgery were linked to a higher likelihood of needing surgery after the initial injection, with one-third of patients with advanced arthritis undergoing surgery within 5 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thumb Carpometacarpal Arthritis: Prognostic Indicators and Timing of Further Intervention Following Corticosteroid Injection. Ostergaard, PJ., Hall, MJ., Dowlatshahi, AS., et al.[2022]

In a double-blind, randomized controlled trial involving 40 patients with osteoarthritis of the thumb, corticosteroid injections did not show any significant improvement in pain or joint function compared to placebo at 24 weeks.

While some short-term improvements were noted in both the steroid and placebo groups, ultimately, intra-articular steroid injections did not provide a clinical benefit for patients with moderate to severe osteoarthritis in the carpometacarpal joint.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. Meenagh, GK., Patton, J., Kynes, C., et al.[2018]

Anti-TNF treatments can effectively reduce inflammation and sub-clinical atherosclerosis in rheumatoid arthritis patients, but they also pose significant risks, including severe infections and alterations in lipid profiles.

There is ongoing debate about the safety of anti-TNF drugs, particularly regarding their potential to increase the risk of demyelinating diseases, making them unsuitable for patients with multiple sclerosis or similar conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concerns about the safety of anti-TNF agents when treating rheumatic diseases. Atzeni, F., Nucera, V., Gerratana, E., et al.[2022]

A systematic review of 31 studies involving over 1 million rheumatoid arthritis patients found no significant differences in safety between various biological therapies, including TNF inhibitors and non-TNF therapies, suggesting they are comparably safe.

Abatacept was associated with a lower risk of cardiovascular events compared to TNF inhibitors, indicating it may be a safer option for patients concerned about heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis. de Queiroz, MJ., de Castro, CT., Albuquerque, FC., et al.[2022]

Tumor necrosis factor (TNF) antagonists, including infliximab, etanercept, and adalimumab, have shown significant safety and efficacy in treating rheumatoid arthritis, with data collected from over 393,000 patients indicating manageable safety profiles.

While there are potential risks associated with anti-TNF agents, such as infections and injection-site reactions, these are generally manageable, and the overall benefit-to-risk profile remains favorable for patients with rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does safety make a difference in selecting the right TNF antagonist? Fleischmann, R., Yocum, D.[2018]

A systematic review of 93 randomized controlled trials involving 31,023 patients revealed a total of 21,498 adverse events (AEs), with 58% of these AEs being suitable for self-reporting by patients, highlighting the importance of patient perspectives in understanding treatment harms.

The study found a lack of systematic reporting on the severity of AEs, with only 9% of trials providing discernible severity grading, indicating a need for standardized frameworks to improve harm reporting in rheumatology research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. Berthelsen, DB., Woodworth, TG., Goel, N., et al.[2021]

In a study of 29 patients with rheumatoid arthritis treated with etanercept for up to four years, the treatment showed significant efficacy, with 90% of patients achieving at least a 20% improvement in symptoms (ACR20) after four years.

The long-term use of etanercept was found to be safe, with severe adverse events occurring rarely and not at a higher frequency than expected, suggesting it is a viable option for chronic inflammatory disease management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Four-year observation of etanercept therapy for rheumatoid arthritis in a single German center]. Schotte, H., Schorat, MA., Willeke, P., et al.[2018]

Citations

1. France pubmed.ncbi.nlm.nih.gov

Intra-articular injection of autologous bone marrow aspirate concentrate in the treatment of osteoarthritis of the thumb first carpometacarpal joint: A pilot study. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Injection therapy for base of thumb osteoarthritis: a systematic review and meta-analysis. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Thumb Carpometacarpal Arthritis: Prognostic Indicators and Timing of Further Intervention Following Corticosteroid Injection. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Concerns about the safety of anti-TNF agents when treating rheumatic diseases. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Does safety make a difference in selecting the right TNF antagonist? [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. [2021]

10. Germany pubmed.ncbi.nlm.nih.gov

[Four-year observation of etanercept therapy for rheumatoid arthritis in a single German center]. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Trapeziometacarpal Joint Arthroplasty of the Thumb without Osseous Tunnels and Carpal Tunnel Release via a Radial Approach; Technique, and Results. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Volume of the Thumb Carpometacarpal Joint. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Ultrasound-guided intra-articular injection of the trapeziometacarpal joint: description of technique. [2022]