Preventative Surgery for Contracture

Overseen By Sanjeev Kakar, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

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

Compensation: Varies

Number of Visits: 1

50 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Division/manipulation of the cord, Pretendinous cord excision for preventing contracture?

The research on spinal cord treatments suggests that surgical interventions, like those for tethered cord syndrome, can be effective in preventing complications. Although not directly related to contracture, these studies indicate that surgical manipulation of the cord can have positive outcomes in preventing further issues. ^{1 2 3 4 5}

How does the treatment of division/manipulation of the cord and pretendinous cord excision differ from other treatments for contracture?

This treatment is unique because it involves directly cutting or removing the cord causing the contracture, which is different from other methods that may focus on skin flaps or muscle repositioning. It aims to address the root cause of the contracture by targeting the cord itself, potentially offering a more direct and effective solution. ^{6 7 8 9 10}

What is the purpose of this trial?

Research is instrumental for improving medical care and the patient experience. Finding new surgical techniques can create better outcomes and minimize recovery time and complications for patients. Some patients undergoing trigger finger surgery with a pre-existing Dupuytren's cord may develop a thickened surgical scar after surgery, which can cause discomfort, difficulty with moving or using, and other complications in the affected finger(s) or hand. The investigator is investigating a surgical technique to minimize these potential complications and scarring after surgery. Subjects are being asked to take part in this research study because they have been diagnosed with trigger finger and pretendinous Dupuytren's cord and have decided to undergo surgery rather than try medical treatment.

Research Team

Sanjeev Kakar, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Occult spinal dysraphism: lessons learned by retrospective analysis of 149 surgical cases about natural history, surgical indications, urodynamic testing, and intraoperative neurophysiological monitoring. [2021]

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

Safety and efficacy of concurrent pediatric spinal cord untethering and deformity correction. [2011]

3. China pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis of minimally invasive surgery in children with occult tethered cord syndrome. [2022]

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

Progressive-Tension Sutures in Reconstruction of Posterior Trunk Defects in Pediatric Patients: A Prospective Series. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Cervical Split Cord Malformations: A Systematic Review. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Attitude of the paralytic supination of the forearm in children. Surgical treatment in 19 cases]. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Musculocutaneous flap containing upper part of bilateral trapezius muscles in the treatment of cicatricial contracture deformity of neck]. [2006]

8. China pubmed.ncbi.nlm.nih.gov

[Surgical strategy for postburn cervical scar contracture]. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Supraclavicular bilobed fasciocutaneous flap for postburn cervical contractures. [2007]

10. China pubmed.ncbi.nlm.nih.gov

[Repair of cervical scar contracture with flaps containing cervical cutaneous branch of the transverse cervical artery]. [2022]