Upper-Extremity Bone or Joint Surgery: Long Term Outcome

Upper Extremity Fractures Clinical Trial

Official title:

Upper-Extremity Bone or Joint Surgery: Long Term Outcome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02366221
• Other study ID #: 1999P008705
• Status: Enrolling by invitation
• Start date: January 1998
• Est. completion date: December 2026

Study information

• Verified date: June 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 750
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• 60-minute visit to the outpatient clinic
An interview, an injury-specific physical exam and/or a set of xrays.
• Phone Interview
If subject cannot return to office in Boston, researcher may conduct interview over the phone.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Range of Motion	Range of motion of joints measured in degrees with goniometer	5 years (expected average)
Secondary	Upper Extremity Function	PROMIS (Patient Reported Outcomes Measurement Information Systems) Upper Extremity Questionnaire	5 years (expected average)
Secondary	Pain Interference	PROMIS Pain Interference Questionnaire	5 years (expected average)
Secondary	Depression	PROMIS Depression Questionnaire	5 years (expected average)