NCT03155854

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Sep 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Sep 2016Dec 2026

Study Start

First participant enrolled

September 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

10.3 years

First QC Date

October 7, 2016

Last Update Submit

March 12, 2026

Conditions

Dupuytren Contracture

Outcome Measures

Primary Outcomes (2)

  • Change in Scar Progression as measured by the Vancouver Scar Scale

    The Vancouver Scar Scale assesses 4 variables: vascularity, height/thickness, pliability, and pigmentation. Patient perception of his or her respective scars is not factored in to the overall score. The scores can range from 0 (normal) to 13 (severe scarring).

    baseline, up to 1 year

  • Change in Scar Progression as measured by the Patient and Observer Scar Assessment Scale

    The Patient and Observer Scar Assessment Scale consists of two parts: a Patient Scale and an Observer Scale. Both scales contain seven items that are scored numerically on a 10-step scale. Together they make up the 'Total Score' of the Patient and Observer Scale. The total score can range from 14 (normal) to 140 (worst scar imaginable).

    baseline, up to 1 year

Study Arms (2)

Pretendinous cord excision

ACTIVE COMPARATOR

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

Procedure: Pretendinous cord excision

Division/manipulation of the cord

ACTIVE COMPARATOR

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

Procedure: Division/manipulation of the cord

Interventions

Pretendinous cord excisionPROCEDURE

The cord/palmar fascia will be excised during surgery.

Pretendinous cord excision
Division/manipulation of the cordPROCEDURE

The pretendinous cord will be divided and incised during surgery.

Division/manipulation of the cord

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Potential candidates for the study will be selected based upon clinical diagnosis of trigger finger with co-existing pretendinous cord. All potential subjects will have either failed non operative treatment or elected surgical treatment.

You may not qualify if:

  • \<18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Dupuytren Contracture

Condition Hierarchy (Ancestors)

FibromaNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsContractureMuscular DiseasesMusculoskeletal DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sanjeev Kakar, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sanjeev Kakar, MD

CONTACT

Kakar.Sanjeev@mayo.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedics,

Study Record Dates

First Submitted

October 7, 2016

First Posted

May 16, 2017

Study Start

September 1, 2016

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)