NCT00575458

Brief Summary

This study is comparing two different kinds of splints for patients who have had a surgical contracture release of dupuytren's disease. It compares a static splint and a dynamic splint.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

June 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

November 16, 2010

Status Verified

November 1, 2010

Enrollment Period

5 years

First QC Date

December 14, 2007

Last Update Submit

November 15, 2010

Conditions

Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

  • DASH questionnaire, PCS questionnaire, Wahler Physical Symptom Inventory, CESD questionnaire

    6 months

Study Arms (2)

1

Static Splint

2

Dynamic Splint

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Orthopaedic Hand Clinic

You may qualify if:

  • years or older
  • males and females with Dupuytren's contracture
  • patients with contracture of less than 30 degrees of MCP contractions and no contractions of the IP joints

You may not qualify if:

  • previous surgical treatment for Dupuytren's
  • contracture of MCP greater than 30 degrees
  • contraindications for dynamic splinting (upper limb amputees, paresis, ect.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

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

  • David C. Ring, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

June 1, 2005

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

November 16, 2010

Record last verified: 2010-11

Locations

US(1)