50 Participants Needed

CTM Injection for Thumb Arthritis

(CTM CMC Trial)

LR
Overseen ByLexie Reissaus, B.S., CCRP
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Indiana Hand to Shoulder Center

Trial Summary

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.

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.12345

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.678910

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.15111213

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.

Eligibility Criteria

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.
See 1 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment - CTMExperimental Treatment1 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 - SalinePlacebo Group1 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.

Find a Clinic Near You

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+

Findings from Research

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

References

Intra-articular injection of autologous bone marrow aspirate concentrate in the treatment of osteoarthritis of the thumb first carpometacarpal joint: A pilot study. [2022]
Injection therapy for base of thumb osteoarthritis: a systematic review and meta-analysis. [2020]
Low rate of subsequent surgery and serious complications following intra-articular steroid injection for base of thumb osteoarthritis: national cohort analysis. [2021]
Thumb Carpometacarpal Arthritis: Prognostic Indicators and Timing of Further Intervention Following Corticosteroid Injection. [2022]
A randomised controlled trial of intra-articular corticosteroid injection of the carpometacarpal joint of the thumb in osteoarthritis. [2018]
Concerns about the safety of anti-TNF agents when treating rheumatic diseases. [2022]
Safety of biological therapy in patients with rheumatoid arthritis in administrative health databases: A systematic review and meta-analysis. [2022]
Does safety make a difference in selecting the right TNF antagonist? [2018]
Harms reported by patients in rheumatology drug trials: a systematic review of randomized trials in the cochrane library from an OMERACT working group. [2021]
[Four-year observation of etanercept therapy for rheumatoid arthritis in a single German center]. [2018]
11.United Statespubmed.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 Statespubmed.ncbi.nlm.nih.gov
Volume of the Thumb Carpometacarpal Joint. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Ultrasound-guided intra-articular injection of the trapeziometacarpal joint: description of technique. [2022]
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