Upper-Extremity Bone or Joint Surgery: Long Term Outcome

June 11, 2023 updated by: Neal Chung-Jen Chen, Massachusetts General Hospital
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All subjects
Subjects with a history of complex arm trauma
Other: 60-minute visit to the outpatient clinic
An interview, an injury-specific physical exam and/or a set of xrays.
Other: Phone Interview
If subject cannot return to office in Boston, researcher may conduct interview over the phone.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Neal Chen, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 1998

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 16, 2014

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimated)

February 19, 2015

Study Record Updates

Last Update Posted (Estimated)

June 13, 2023

Last Update Submitted That Met QC Criteria

June 11, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 1999P008705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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