A1 Pulley Surgery Techniques for Trigger Finger

Recruiting at 5 trial locations

Overseen By Eric Wagner, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Prisoners, Minors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two surgical methods for treating trigger finger: removing or cutting a part of the tendon sheath. It focuses on patients who haven't improved with other treatments. The goal is to see which method better reduces pain and stiffness by helping the tendon move more freely.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor or the study team.

What data supports the effectiveness of the treatment A1 Pulley Surgery Techniques for Trigger Finger?

Open release of the A1 pulley for trigger finger is generally considered a minor procedure with a low rate of major complications, less than 1% to 4%, and is widely known for its effectiveness in treating trigger finger. ^{1 2 3 4 5}

Is A1 pulley surgery for trigger finger generally safe?

A1 pulley surgery for trigger finger is generally considered safe, with most complications being minor, such as scar pain and tenderness. Major complications like nerve or blood vessel injury and infection are rare, occurring in less than 1% to 4% of cases. ^{1 2 3 6 7}

How does A1 pulley surgery for trigger finger differ from other treatments?

A1 pulley surgery for trigger finger involves either excising (removing) or incising (cutting) the A1 pulley to relieve symptoms. This treatment is unique because it directly addresses the mechanical issue causing the finger to lock, unlike other options like corticosteroid injections, which aim to reduce inflammation. Additionally, newer techniques like nonpalmar endoscopic release may offer benefits such as less scarring and faster recovery compared to traditional open surgery. ^{1 2 4 5 8}

Research Team

Eric Wagner, MD, MS

Principal Investigator

Emory University

Eligibility Criteria

This trial is for adults over 18 with trigger finger syndrome who are undergoing surgery and can give informed consent. It excludes those unable to consent, minors, pregnant women, and prisoners.

Inclusion Criteria

I am having surgery for trigger finger.

I am 18 years old or older.

I am willing and able to agree to participate in the study.

Exclusion Criteria

Pregnant women

I am under 18 years old.

I am unable to give consent for medical procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgical treatment with either excision or incision of the A1 pulley for trigger finger

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

1 year

Visits at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year (in-person)

Treatment Details

Interventions

• Excision of the A1 pulley
• Incision of the A1 pulley in the standard fashion

Trial Overview The study compares two surgical treatments for trigger finger: excision (complete removal) versus incision (cutting) of the A1 pulley. The goal is to see which method offers better pain relief, less stiffness, and lower recurrence rates.

Participant Groups

Group I: excision of the A1 pulley Experimental Treatment 1 Intervention

Group II: incision of the A1 pulley in the standard fashion Active Control 1 Intervention

Excision of the A1 pulley is already approved in United States, European Union for the following indications:

Approved in United States as A1 Pulley Release for:

• Trigger Finger
• Stenosing Tenosynovitis

Approved in European Union as Trigger Finger Release for:

• Trigger Finger
• Stenosing Tenosynovitis

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Findings from Research

In a study of 43 patients who underwent 78 open trigger finger releases, the major complication rate was found to be low at 3%, with only two cases requiring further intervention.

However, the minor complication rate was notably high at 28%, with issues such as decreased range of motion and scar tenderness being common, indicating that patients should be informed about these potential outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications of open trigger finger release. Will, R., Lubahn, J.[2010]

Patients treated with a nonpalmar endoscopic approach for trigger finger showed significantly better scar outcomes compared to those who underwent standard open surgery, particularly noticeable at 1 week and 1 month post-operation.

Both techniques were equally effective in treating trigger finger, with the endoscopic group returning to work sooner and reporting higher overall satisfaction, although these differences were not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpalmar Endoscopic versus Open Trigger Finger Release: Results from a Prospective Trial. Brown, AM., Tanabe, KL., DellaMaggiora, RJ., et al.[2022]

In a case series of three patients who underwent open A1 pulley release for trigger finger, all developed severe postoperative infections that led to significant complications, including flexor tenosynovitis and the need for multiple surgeries.

Despite the rarity of major complications (less than 1% to 4%), this study emphasizes that untreated infections, especially in diabetic patients, can result in permanent functional deficits, highlighting the need for prompt diagnosis and treatment of postoperative infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Not Just Another Trigger Finger. Effendi, M., Yuan, F., Stern, PJ.[2023]

In a study of 36 patients with trigger finger and associated proximal interphalangeal (PIP) joint contractures, resection of the flexor digitorum superficialis (FDS) after A1 pulley release significantly improved PIP joint extension, reducing the mean contracture from 24° preoperatively to 4° postoperatively.

The procedure was effective, with 72% of fingers achieving full extension immediately after surgery, and all fingers eventually reaching full range of motion after physical therapy and a betamethasone injection, indicating a promising treatment option for this specific patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resection of the flexor digitorum superficialis for trigger finger with proximal interphalangeal joint positional contracture. Favre, Y., Kinnen, L.[2022]

In a review of 7 randomized controlled trials involving 676 patients, percutaneous A1 pulley release surgery for trigger digit showed no significant difference in treatment failure or complication rates compared to open surgery.

Patients who underwent percutaneous release experienced significantly lower treatment failure rates and higher satisfaction levels compared to those treated with corticosteroid injections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous release, open surgery, or corticosteroid injection, which is the best treatment method for trigger digits? Wang, J., Zhao, JG., Liang, CC.[2021]

In a study using 14 cadaveric hands, percutaneous release of the A1 pulley for trigger fingers showed a high success rate, with 72% of releases being complete and no significant neurovascular injuries reported.

While there were some instances of tendon scoring and partial lacerations, the overall safety and efficacy of using a #15 scalpel blade for this procedure suggest it could be a viable treatment option for patients with trigger finger.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous release of the A1 pulley: a cadaver study. Habbu, R., Putnam, MD., Adams, JE.[2022]

The study demonstrated that percutaneous release of the A1 pulley using a 15° stab knife achieved a high success rate of 100% in releasing the pulley in 85 out of 100 fingers, indicating its effectiveness as a treatment for trigger fingers.

The procedure showed a relatively low complication rate, with only 17 fingers experiencing superficial tendon scrapes and no significant injuries to digital nerves, blood vessels, or the A2 pulley, suggesting it is a safe alternative when conservative treatments fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cadaveric assessment of percutaneous trigger finger release with 15° stab knife: its effectiveness and complications. Abdoli, A., Asadian, M., Banadaky, SHS., et al.[2021]

In a study of 28 operative thumbs from 24 pediatric patients, a surgical technique involving complete release of the annular pulley and partial release of the oblique pulley resulted in no recurrence of thumb locking or triggering, indicating a successful treatment for locked trigger thumb.

Post-surgery, most patients experienced resolution of Notta's node and high satisfaction rates, with only minor reductions in thumb motion observed, suggesting that the procedure is both effective and safe for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete annular and partial oblique pulley release for pediatric locked trigger thumb. Kuo, M., Rayan, GM.[2022]

References

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

Complications of open trigger finger release. [2010]

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

Nonpalmar Endoscopic versus Open Trigger Finger Release: Results from a Prospective Trial. [2022]

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

Not Just Another Trigger Finger. [2023]

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

Resection of the flexor digitorum superficialis for trigger finger with proximal interphalangeal joint positional contracture. [2022]

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

Percutaneous release, open surgery, or corticosteroid injection, which is the best treatment method for trigger digits? [2021]

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

Percutaneous release of the A1 pulley: a cadaver study. [2022]

7. England pubmed.ncbi.nlm.nih.gov

A cadaveric assessment of percutaneous trigger finger release with 15° stab knife: its effectiveness and complications. [2021]

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

Complete annular and partial oblique pulley release for pediatric locked trigger thumb. [2022]