Upper Extremity FracturesNCT02366221
Upper-Extremity Bone or Joint Surgery: Long Term Outcome
An observational study of Upper Extremity Fractures and Upper Extremity Non-Fracture Bone and Joint Conditions, run by Massachusetts General Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Extremity Fractures, Upper Extremity Non-Fracture Bone and Joint Conditions
- What is being tested?
- 60-minute visit to the outpatient clinic and Phone Interview
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Jan 1998to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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
Who may be able to join
- Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service
Who cannot join
- Vulnerable populations
About this study
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.
- Being tested
- 60-minute visit to the outpatient clinic, Phone Interview
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60-minute visit to the outpatient clinicOther
An interview, an injury-specific physical exam and/or a set of xrays.
Phone InterviewOther
If subject cannot return to office in Boston, researcher may conduct interview over the phone.
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Subjects with a history of complex arm trauma Receives: Other: 60-minute visit to the outpatient clinic; Other: Phone Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Range of Motion
Range of motion of joints measured in degrees with goniometer
Measured: 5 years (expected average)
Secondary outcomes (3)
Upper Extremity Function
PROMIS (Patient Reported Outcomes Measurement Information Systems) Upper Extremity Questionnaire
Measured: 5 years (expected average)
Pain Interference
PROMIS Pain Interference Questionnaire
Measured: 5 years (expected average)
Depression
PROMIS Depression Questionnaire
Measured: 5 years (expected average)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startJan 1998
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Extremity FracturesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neal Chung-Jen Chen, Massachusetts General Hospital
- Investigators
- Neal Chen, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366221
- Sponsor's protocol ID
- 1999P008705
- Status last verified
- Nov 2025
- First submitted
- 16 Oct 2014
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper-Extremity Bone or Joint Surgery: Long Term Outcome
- ClinicalTrials.gov ID
- NCT02366221
- Acronym / sponsor ID
- 1999P008705
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jan 1998 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 19 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | – | Other: 60-minute visit to the outpatient clinic, Other: Phone InterviewSubjects with a history of complex arm trauma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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
Key inclusion criteria (1 listed)
- Subjects with a history of complex arm or leg trauma who have completed their normal care in the Orthopaedic Hand and Upper Extremity Service
Key exclusion criteria (1 listed)
- Vulnerable populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 60-minute visit to the outpatient clinicAn interview, an injury-specific physical exam and/or a set of xrays. | Other | All subjects |
| Phone InterviewIf subject cannot return to office in Boston, researcher may conduct interview over the phone. | Other | All subjects |
Primary outcome
Range of Motion
Time frame: 5 years (expected average)
Range of motion of joints measured in degrees with goniometer
3 secondary outcomes
Upper Extremity Function
Time frame: 5 years (expected average)
Pain Interference
Time frame: 5 years (expected average)
Depression
Time frame: 5 years (expected average)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neal Chen, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Extremity Fractures and Upper Extremity Non-Fracture Bone and Joint Conditions, run by Massachusetts General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Range of Motion (time frame: 5 years (expected average)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2025.