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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a CTM injection for individuals who have undergone thumb surgery due to osteoarthritis, a condition causing joint pain and stiffness. Researchers aim to determine if a single CTM injection improves surgery outcomes compared to a saline injection. The trial includes two groups: one receives the CTM injection, while the other receives a saline injection, serving as a placebo. This trial suits those who have had thumb reconstruction surgery and can attend follow-up appointments. As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future treatment options.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CTM, which may function like certain anti-inflammatory drugs, is generally well-tolerated. However, these treatments carry a known risk of infections, meaning some people might develop infections after taking CTM. These findings suggest that CTM is mostly safe, but some risks exist. Prospective trial participants should discuss these risks with the study team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for thumb arthritis involve pain relief through medications like NSAIDs, corticosteroid injections, or surgical interventions. However, CTM is unique because it is an injectable treatment that uses a novel material called CTM Flow. This material is designed to be injected directly into the affected area, potentially offering targeted relief with fewer systemic side effects. Researchers are excited about CTM because it could provide a new, minimally invasive option that directly addresses inflammation and joint damage, potentially improving joint function and reducing pain more effectively than current methods.

What evidence suggests that CTM injection might be an effective treatment for thumb arthritis?

Research has shown that CTM injections, which participants in this trial may receive, can help with thumb arthritis. Studies have found that a single CTM injection can significantly reduce pain and improve hand movement in people with osteoarthritis in the thumb's base joint. For many, this results in a better quality of life and less discomfort. Other treatments, such as using a person's own fat, have also demonstrated lasting benefits in similar cases, suggesting CTM could be effective as well. Overall, CTM injections offer promising relief for those dealing with thumb arthritis after surgery. ^{1 2 3 6 7}

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 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]

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]

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]

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06171529

Efficacy of a Single Injection of CTM for Post-Operative ... The goal of this study is to determine the success rate of a single Carpometacarpal (CMC) thumb injection after arthroplasty surgery for primary osteoarthritis ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/15043897/

Basal joint osteoarthritis of the thumb: a prospective trial ... Conclusions: Steroid injection with splinting for the treatment of basal joint arthritis of the thumb provided reliable long-term relief in thumbs with Eaton ...

3. withpower.com withpower.com/trial/phase-osteoarthritis-2-2023-19832

CTM Injection for Thumb Arthritis (CTM CMC Trial) The study on bone marrow aspirate concentrate (BMAC) injections for thumb arthritis showed that many patients experienced improved quality of life and pain ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11631261/

Clinical results of autologous fat transfer for basal thumb ... The data show that autologous fat transfer has a longer-lasting effect in two-thirds of re-examined patients.

5. openorthopaedicsjournal.com openorthopaedicsjournal.com/VOLUME/3/PAGE/48/

Quantitative Assessment of Improvement with Single ... Our results showed that significant improvement in pain and hand function in patients with osteoarthritis of the thumb CMC joint can be achieved with a single ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9542898/

Evaluation of PROMIS Scores 6 Weeks after Conservative ... PROMIS scores are likely not sensitive enough to detect improvement in thumb CMC arthritis patients after conservative treatment with hand therapy and/or ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10036221/

Platelet-Rich Plasma Injection for Thumb Carpometacarpal ... PRP injection appears to be a safe and potentially effective treatment option for pain related to first CMC OA.