Orthopaedic Hand Service Data Repository | NCT01393262

Studies
Orthopaedic Hand Service Data Repository

NCT01393262

Sponsor

Massachusetts General Hospital

Status

Completed

Last Update Posted

Jan 12, 2021Actual

Enrollment

9,620Actual

Phase

Not provided

Conditions

Non-traumatic and Traumatic Health Issues

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2009Actual

Primary Completion Date

Dec 2020Actual

Completion Date

Dec 2020Actual

First Submitted Date

Jul 11, 2011

First Submission Date that Met QC Criteria

Jul 12, 2011

First Posted Date

Jul 13, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 9, 2021

Last Update Posted Date

Jan 12, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neal Chung-Jen Chen, Principal Investigator; Director of Research, Hand Service, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion).

The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9,620Actual

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Over 18 years
Patients presenting to Hand Service for traumatic or non-traumatic issues.
English Speaking

Exclusion Criteria:

under 18 years
vulnerable population

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All individuals will be over the age of 18 and English speaking, excluding vulnerable populations (mental disabilities, prisoners etc.). Patients may be traumatic or non-traumatic.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Neal Chen, MD	Massachusetts General Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States

Label	Type	Description	Intervention Names
Healthy Escort
Hand Service patient