NCT05998148

Brief Summary

This study will compare patient reported outcomes (PROs) of patients seen at virtual phone visits compared to in-person visits for 6 weeks, 12 weeks, and 6 months post-operative follow up at a sports medicine clinic. This study will determine if there is a difference in PROs between these two groups of patients. The investigators hypothesize patients who are seen during a virtual phone visit will report different PRO compared to patients who are seen during an in-person visit for post-operative follow-up at 6-months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2024

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

December 15, 2025

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

August 10, 2023

Results QC Date

November 26, 2025

Last Update Submit

December 11, 2025

Conditions

Keywords

patient reported outcomestelemedicinevirtualphonesports medicinein person

Outcome Measures

Primary Outcomes (1)

  • PROMIS Physical and Mental Scores

    Patient-Reported Outcomes Measurement Information System (PROMIS) GLOBAL Survey is divided into PROMIS Physical and PROMIS Mental. Minimum score 16.2, Maximum Score 67.2 for PROMIS Physical. Minimum score 21.2, Maximum score 67.6 for PROMIS Mental. Higher score means better outcome.

    6 month post-operative visit

Secondary Outcomes (3)

  • Knee Injury and Osteoarthritis Outcome Score for Joint Replacement

    6 month post-operative visit

  • Oxford Shoulder Score

    6 month post-operative visit

  • Patient Satisfaction Scores

    6 month post-operative visit

Study Arms (2)

standard in-person appointment visits

NO INTERVENTION

Randomly selected participants will receive standard in-person post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.

virtual phone appointment visits

EXPERIMENTAL

Randomly selected participants will receive virtual telemedicine post-operative appointment visits at 6 week, 12 week, and 6 months after surgery.

Other: virtual phone appointment visits

Interventions

Patient will have post-operative appointments that place with telemedicine. The visits will will be virtual phone appointments scheduled at approximately 6 weeks, 12 weeks, and 6 months after surgery.

virtual phone appointment visits

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants are at least 18 years of age.
  • Participants who are seen at Harbor-UCLA Medical Center sports medicine clinic.
  • Participants have agreed to have operative intervention.
  • Participants must own a phone with reliable calling capabilities.
  • The Participants must have access to reliable internet to fill out the online survey.
  • The Participants must be able to provide consent.
  • Participants may include pregnant patients.

You may not qualify if:

  • Patients that are under the age of 18
  • any cognitive impaired adult
  • any adult unable to provide consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Related Publications (3)

  • Sharareh B, Schwarzkopf R. Effectiveness of telemedical applications in postoperative follow-up after total joint arthroplasty. J Arthroplasty. 2014 May;29(5):918-922.e1. doi: 10.1016/j.arth.2013.09.019. Epub 2013 Dec 15.

    PMID: 24342278BACKGROUND
  • Grandizio LC, Foster BK, Klena JC. Telemedicine in Hand and Upper-Extremity Surgery. J Hand Surg Am. 2020 Mar;45(3):239-242. doi: 10.1016/j.jhsa.2019.09.007. Epub 2019 Nov 9.

    PMID: 31718846BACKGROUND
  • Preston N, McHugh GA, Hensor EMA, Grainger AJ, O'Connor PJ, Conaghan PG, Stone MH, Kingsbury SR. Developing a standardized approach to virtual clinic follow-up of hip and knee arthroplasty. Bone Joint J. 2019 Aug;101-B(8):951-959. doi: 10.1302/0301-620X.101B8.BJJ-2018-1566.R1.

    PMID: 31362551BACKGROUND

MeSH Terms

Conditions

Patient SatisfactionAthletic InjuriesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorWounds and Injuries

Limitations and Caveats

One of the limitations was the sample size. A second limitation was that we stopped recruitment at 90 patients because of time constraints instead of reaching the goal of 104 patients. A third limitation was the different methods which the virtual telemedicine visits took place. A fourth limitation was the different methods used to complete the surveys.

Results Point of Contact

Title
Jonathan Wu
Organization
Lundquist Institute for Biomedical Innovation

Study Officials

  • John P Andrawis, M.D.

    Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

March 1, 2022

Primary Completion

December 31, 2023

Study Completion

January 24, 2024

Last Updated

December 15, 2025

Results First Posted

December 15, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

The individual participant data that results in a publication will be made available upon request.

Time Frame
information will be made available starting after publication. The information will be available for 3 years after publication.
Access Criteria
Criteria include other researchers interested in patient reported outcomes, for analyses related to telemedicine. Study coordinator will review requests for more data.

Locations