Preventative Surgery for Contracture

Overseen By Sanjeev Kakar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Under 18

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new surgical techniques to improve outcomes for people with trigger finger and a Dupuytren's cord. The goal is to reduce scarring and complications after surgery, making recovery easier for patients. Participants will undergo one of two surgical methods focused on the Dupuytren's cord: division/manipulation of the cord or pretendinous cord excision. Ideal candidates for this study are those diagnosed with trigger finger alongside a Dupuytren's cord who have chosen surgery over other treatments. As an unphased trial, this study offers patients the chance to contribute to innovative surgical advancements that could enhance recovery experiences.

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 the trial coordinator or your doctor.

What prior data suggests that this surgical technique is safe?

Research has shown that the treatments studied for contracture surgery have varying safety levels. For the method involving dividing or manipulating the cord, studies indicate a lower likelihood of recurrence. However, there is a small risk of complications, such as nerve damage, though these are uncommon.

In contrast, removing the cord has a reported complication rate ranging from 14% to 67%, depending on various factors. The most common issues involve surgical site healing. Despite these risks, this method often results in better long-term outcomes with fewer recurrences compared to other techniques.

Both treatments have advantages and disadvantages, and these should be considered when contemplating participation in a trial. Consulting healthcare providers is essential to determine the best option for individual situations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these surgical techniques for treating Dupuytren's contracture because they offer more targeted approaches than traditional methods. While conventional treatments like needle aponeurotomy and collagenase injections work by breaking down the cord causing finger contractures, the division/manipulation and excision techniques directly address the underlying Dupuytren's fascia. By incising or removing the affected fascia, these procedures aim to reduce recurrence rates and potentially provide longer-lasting results. This could mean fewer follow-up treatments and a more durable correction for patients.

What evidence suggests that this trial's surgical techniques could be effective for minimizing complications and scarring after surgery?

In this trial, participants will be assigned to one of two treatment arms. Research has shown that about 76% of patients experience improvement when the Dupuytren's cord is manipulated, although 85% report some side effects. This indicates that many patients benefit, but there is a significant risk of side effects. Participants in one arm of this trial will undergo this division/manipulation of the cord.

Conversely, removing the cord, known as pretendinous cord excision, has successfully addressed finger bending issues. Studies have shown it significantly improves hand movement both in the short and long term. This method effectively reduces the tightness that hinders finger movement. Participants in the other arm of this trial will undergo this excision procedure. Both treatments aim to enhance hand and finger use, but each has its own benefits and risks. ^{2 4 6 7 8}

Who Is on the Research Team?

Sanjeev Kakar, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults with trigger finger and a condition called Dupuytren's Contracture, who haven't had success with non-surgical treatments and have chosen to undergo surgery.

Inclusion Criteria

Non-surgical treatments didn't work for me or I chose surgery.

I have been diagnosed with trigger finger and have a cord in my palm.

Exclusion Criteria

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo either a targeted palmar fasciectomy procedure with division or excision of the Dupuytren's fascia

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in scar progression using the Vancouver Scar Scale and the Patient and Observer Scar Assessment Scale

up to 1 year

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Division/manipulation of the cord
• Pretendinous cord excision

Trial Overview The study tests a surgical technique that removes or manipulates the pretendinous cord during trigger finger surgery, aiming to reduce scarring and improve recovery.

How Is the Trial Designed?

Group I: Division/manipulation of the cord Active Control 1 Intervention

patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be incised.

Group II: Pretendinous cord excision Active Control 1 Intervention

Patients will undergo either a targeted palmar fasciectomy procedure in which the involved Dupuytren's fascia will be excised

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31818174/

The effectiveness of manipulation of fingers with ... Clinical success was achieved in 41% and clinical improvement in 76% of the patients. Adverse events were reported by 85%. The outcomes were ...

2. jhandsurg.org jhandsurg.org/article/S0363-5023(25)00154-6/fulltext

The Impact of Emerging Therapies and Declining ... From 2000 to 2021, DC treatment volumes increased by 468%, with CCH becoming the most widely used treatment, accounting for 61% of all ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2771519

Cost-effectiveness of Recurrent Dupuytren Contracture ... This economic evaluation identifies the most cost-effective treatment regimen for patients with recurrent Dupuytren contracture.

4. emedicine.medscape.com emedicine.medscape.com/article/329414-treatment

Dupuytren Contracture Treatment & Management The results of another study revealed the severity of contracture preoperatively had a significantly negative effect on hand power, and older ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2312631

Collagenase Injection versus Limited Fasciectomy for ... Collagenase was shown to be better than placebo in correcting the contracture to within 0 to 5 degrees of full extension at 30 days.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11693408/

Dupuytren's Contracture: A Review of the Literature - PMC While it tends to have lower recurrence rates compared to limited fasciectomy, radical fasciectomy carries a higher risk of complications such as nerve damage, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0363502306003054

Dupuytren's disease A Comparison of the Direct Outcomes ... This study is the first part of a long-term study that will follow up patients with Dupuytren's disease for 5 years after treatment with either PNF or LF.

8. jhandsurg.org jhandsurg.org/article/S0363-5023(21)00427-5/fulltext

Dupuytren Contractures: An Update of Recent Literature Recent studies have provided additional data regarding the pathophysiology, indications, outcomes, and costs associated with the treatment for ...