Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting

NCT05095415 | Withdrawn

• 1 other identifier: MethodistUNC
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This will be a prospective randomized control trial with a blocking method to determine the effect of an occupational therapy focused pre-operative education on 3 pre-determined diagnosis: Carpometacarpal (CMC) Arthroplasty, Distal radius fracture requiring open reduction internal fixation (ORIF) and tendon repairs of the hand. Possible participants will be recruited through Cape Fear Orthopedics \& Sports Medicine and receiving care from an orthopedic surgeon \& hand specialist. Researchers hypothesize that those who receive the occupational therapy consult will demonstrate improved adherence with occupational therapy appointments, improved patient perceived function, and overall improved experiences with the pre-operative patient experience.

Conditions

Flexor Tendon Rupture; Thumb Osteoarthritis; Distal Radius Fracture

Keywords

Occupational Therapy; Pre-operative Education; Upper Extremity

Outcome Measures

Primary Outcomes (4)

• Patient appointment attendance

  Patient adherence to scheduled occupational therapy visits

  Through completion of therapy, up to one year.

• Upper Extremity Functional Index

  Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

  Date of first attended postoperative therapeutic appointment, up to 15 days following surgery

• Upper Extremity Functional Index

  Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

  Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation

• Upper Extremity Functional Index

  Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction

  Upon discharge from therapeutic services, up to one year

Secondary Outcomes (1)

• QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)

  Date of first attended postoperative therapeutic appointment, up to 15 days following surgery

Study Arms (2)

Typical Pre-operative Experience

ACTIVE COMPARATOR

Participants will be be placed in appropriate subgroups based upon their diagnosis and surgical intervention. Subgroups include: CMC Arthroplasty, ORIF of the Distal Radius, and Flexor/Extensor Tendon Repairs.

Other: Typical Pre-Operative Education

Occupational Therapy Consult Experience

EXPERIMENTAL

Participants will be be placed in appropriate subgroups based upon their diagnosis and surgical intervention. Subgroups include: CMC Arthroplasty, ORIF of the Distal Radius, and Flexor/Extensor Tendon Repairs.

Other: Occupational Therapy Pre-operative Consult

Interventions

Occupational Therapy Pre-operative Consult OTHER

Preoperative education will be given by the treating orthopedic surgeon first and will then be followed by a consult with a final semester, occupational therapy student. The pre-operative education will include the importance of attending therapy, what to expect at therapy, typical duration of therapy for their specific diagnosis, and address any questions of ther participant. Participants will be given educational materials and access to education videos to watch if they so choose.

Occupational Therapy Consult Experience

Typical Pre-Operative Education OTHER

Participants will receive all preoperative education from their orthopedic surgeon and will not be spoken to directly about the therapeutic process until their first scheduled therapy appointment.

Typical Pre-operative Experience

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of Distal Radius Fracture, requiring open reduction internal fixation
• Clinical diagnosis of flexor tendon of the hand laceration
• Clinical diagnosis of CMC arthritis, electing to undergo CMC arthroplasty
• Receiving care from Cape Fear Orthopedics \& Sports Medicine
• English Speaking

You may not qualify if:

• Less than 18 years old
• Elect not to receive therapeutic services at Cape Fear Orthopedics \& Sports Medicine.

Sponsors & Collaborators

• Cape Fear Orthopedics & Sports Medicine: collaborator
• Methodist University, North Carolina: lead

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to the knowledge of if they are receiving the typical pre-operative care or an additional individualized occupational therapy consult.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to the experimental or control group in accordance with their diagnosis specific block. This will be continued until there is at least 5 participants in each diagnosis block.

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 27, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 26, 2025

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share