Upper-Extremity Bone or Joint Surgery: Long Term Outcome | NCT02366221

Studies
Upper-Extremity Bone or Joint Surgery: Long Term Outcome

NCT02366221

Sponsor

Massachusetts General Hospital

Status

Enrolling by invitation

Last Update Posted

Nov 24, 2025Actual

Enrollment

750Estimated

Phase

Not provided

Conditions

Upper Extremity Fractures
Upper Extremity Non-Fracture Bone and Joint Conditions

Interventions

60-minute visit to the outpatient clinic
Phone Interview

Countries

Not provided

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

Nov 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998Actual

Primary Completion Date

Dec 2026Estimated

Completion Date

Dec 2027Estimated

First Submitted Date

Oct 16, 2014

First Submission Date that Met QC Criteria

Feb 11, 2015

First Posted Date

Feb 19, 2015Estimated

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

Nov 19, 2025

Last Update Posted Date

Nov 24, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Neal Chung-Jen Chen, Principal Investigator, Massachusetts General HospitalPrincipal Investigator

Lead Sponsor

Massachusetts General HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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 specific aim of the study is to obtain long-term follow-up information on patients who have completed their standard clinical care in the Orthopaedic Hand and Upper Extremity Service. The study will help to qualify and quantify long-term recovery and outcomes from uncommon upper extremity fractures, as well as non-fracture bone and joint conditions. The hypotheses vary, but generally focus on the patterns of injury, the results of treatment and the complications encountered.

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

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

750Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects		Subjects with a history of complex arm trauma	Other: 60-minute visit to the outpatient clinic Other: Phone Interview

Interventions

Name	Type	Description	Arm Group Labels	Other Names
60-minute visit to the outpatient clinic	Other	An interview, an injury-specific physical exam and/or a set of xrays.	All subjects

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Range of Motion	Range of motion of joints measured in degrees with goniometer	5 years (expected average)

Secondary Outcomes

Measure	Description	Time Frame
Upper Extremity Function	PROMIS (Patient Reported Outcomes Measurement Information Systems) Upper Extremity Questionnaire	5 years (expected average)
Pain Interference	PROMIS Pain Interference Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service

Exclusion Criteria:

Vulnerable populations

Accepts Healthy Volunteers

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

Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Not provided