Flexor Tendon RuptureNCT05095415
Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting
A study testing Occupational Therapy Pre-operative Consult and Typical Pre-Operative Education in people with Flexor Tendon Rupture and Thumb Osteoarthritis, run by Methodist University, North Carolina.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Flexor Tendon Rupture, Thumb Osteoarthritis, Distal Radius Fracture
- What is being tested?
- Occupational Therapy Pre-operative Consult and Typical Pre-Operative Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Less than 18 years old
- Previously sustained one of the inclusion criteria diagnoses
- Elect not to receive therapeutic services at Cape Fear Orthopedics \& Sports Medicine.
About this study
Official title: The Effect of an Occupational Therapy Pre-operative Education Consult on Patient Outcomes in the Orthopedic Hand Setting: A Prospective Randomized Block Study
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.
Read the detailed description
Participants will be identified by orthopedic surgeon. Once informed consent is obtained participants will subsequently be randomly assigned to the control or experimental block associated with their diagnosis. Patients will be randomly assigned within their diagnosis block through random number generation in Microsoft Excel. Participants randomly assigned to the control group will receive the current \& typical educational information provided by their orthopedic surgeon. Participants randomly assigned to the experimental group will receive an additional occupational therapy (OT) focused pre-operation education consultation provided by a third year occupational therapy student under the supervision of an orthopedic surgeon \& Occupational Therapist \& Certified Hand Therapist. The additional OT pre-operative consult will be included during participants scheduled pre-operative appointment. Specific pre-op appointments are only conducted when patients have not been seen by a provider within 4-weeks of their surgical date. If surgery is scheduled within 4-weeks of the patients last encounter with a provider an additional pre-op visit is not required. Since two of the three pre-determined diagnosis of interest are typically associated with trauma, participants may receive their OT consult at their first encounter with the orthopedic surgeon which is also considered their pre-op visit.
The OT consult provided to the individuals assigned to the experimental group will consist of a one-on-one interaction with a third year occupational therapy doctorate (OTD) student providing diagnosis specific educational materials inclusive of what to expect after surgery, the importance of attending therapy as recommended by the orthopedic surgeon and how to accurately complete the Upper Extremity Functional Index (UEFI). Outcomes of this research will include UEFI scores at therapeutic evaluation, after 10 visits and upon discharge, completion of a post operative survey via question pro utilizing a Visual Analog Scale (VAS) at the initial therapeutic encounter, and patient compliance with attending therapy as documented by therapy visit attendance. A semi-structured interview will be completed at patient discharge from therapy to determine areas of possible improvement and further research.
Individuals randomly assigned to the control group will participate in the typical pre-operative experience provided by the orthopedic surgeon. Control group participants will not be made aware of experimental group participants experiences. Participants in the control group will be informed that researchers are interested in the pre-operative patient experiences at Cape Fear Orthopedics \& Sports Medicine and their participation in the study and honest responses.
- Being tested
- Occupational Therapy Pre-operative Consult, Typical Pre-Operative Education
- Keywords
- Occupational Therapy, Pre-operative Education, Upper Extremity
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occupational Therapy Pre-operative ConsultOther
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.
Typical Pre-Operative EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Occupational Therapy Pre-operative Consult |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient appointment attendance
Patient adherence to scheduled occupational therapy visits
Measured: 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
Measured: 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
Measured: 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
Measured: Upon discharge from therapeutic services, up to one year
Secondary outcomes (1)
QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)
Patient reported outcome analyzing patient pre-operative experiences. VAS is linear scale where participants visually mark the line corresponding to their preoperative experience. Patients are blinded to the numerical value associated to their answer to decrease biases. VAS is ten point linear scale where 1 represents the negative anchor and 10 represents the positive, preferred response. Questions address anxiety, understanding, and overall preoperative experience.
Measured: Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study startOct 2021 (estimated)
- Primary completionApr 2022 (estimated)
- Study completionOct 2022 (estimated)
Why it stopped: Investigator has left the institution (graduated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon RuptureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Methodist University, North Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Cape Fear Orthopedics & Sports Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095415
- Sponsor's protocol ID
- MethodistUNC
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Occupational Therapy Pre-operative Education Consult on Patient Outcomes in the Orthopedic Hand Setting: A Prospective Randomized Block Study
- ClinicalTrials.gov ID
- NCT05095415
- Acronym / sponsor ID
- MethodistUNC
- Keywords
- Occupational Therapy, Pre-operative Education, Upper Extremity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator has left the institution (graduated)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Methodist University, North CarolinaUniversity, hospital or other
- Collaborators
- Cape Fear Orthopedics & Sports Medicine
- Study start
- Oct 2021 (estimated)
- Primary completion
- Apr 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 27 Oct 2021 (actual)
- 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.
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.
Detailed description
Participants will be identified by orthopedic surgeon. Once informed consent is obtained participants will subsequently be randomly assigned to the control or experimental block associated with their diagnosis. Patients will be randomly assigned within their diagnosis block through random number generation in Microsoft Excel. Participants randomly assigned to the control group will receive the current \& typical educational information provided by their orthopedic surgeon. Participants randomly assigned to the experimental group will receive an additional occupational therapy (OT) focused pre-operation education consultation provided by a third year occupational therapy student under the supervision of an orthopedic surgeon \& Occupational Therapist \& Certified Hand Therapist. The additional OT pre-operative consult will be included during participants scheduled pre-operative appointment. Specific pre-op appointments are only conducted when patients have not been seen by a provider within 4-weeks of their surgical date. If surgery is scheduled within 4-weeks of the patients last encounter with a provider an additional pre-op visit is not required. Since two of the three pre-determined diagnosis of interest are typically associated with trauma, participants may receive their OT consult at their first encounter with the orthopedic surgeon which is also considered their pre-op visit.
The OT consult provided to the individuals assigned to the experimental group will consist of a one-on-one interaction with a third year occupational therapy doctorate (OTD) student providing diagnosis specific educational materials inclusive of what to expect after surgery, the importance of attending therapy as recommended by the orthopedic surgeon and how to accurately complete the Upper Extremity Functional Index (UEFI). Outcomes of this research will include UEFI scores at therapeutic evaluation, after 10 visits and upon discharge, completion of a post operative survey via question pro utilizing a Visual Analog Scale (VAS) at the initial therapeutic encounter, and patient compliance with attending therapy as documented by therapy visit attendance. A semi-structured interview will be completed at patient discharge from therapy to determine areas of possible improvement and further research.
Individuals randomly assigned to the control group will participate in the typical pre-operative experience provided by the orthopedic surgeon. Control group participants will not be made aware of experimental group participants experiences. Participants in the control group will be informed that researchers are interested in the pre-operative patient experiences at Cape Fear Orthopedics \& Sports Medicine and their participation in the study and honest responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Typical Pre-operative Experience | Active comparator | Other: Typical Pre-Operative EducationParticipants 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. |
| Occupational Therapy Consult Experience | Experimental | Other: Occupational Therapy Pre-operative ConsultParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Less than 18 years old
- Previously sustained one of the inclusion criteria diagnoses
- Elect not to receive therapeutic services at Cape Fear Orthopedics \& Sports Medicine.
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 |
|---|---|---|
| Occupational Therapy Pre-operative ConsultPreoperative 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. | Other | Occupational Therapy Consult Experience |
| Typical Pre-Operative EducationParticipants 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. | Other | Typical Pre-operative Experience |
Primary outcome
Patient appointment attendance
Time frame: Through completion of therapy, up to one year.
Patient adherence to scheduled occupational therapy visits
Upper Extremity Functional Index
Time frame: Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Upper Extremity Functional Index
Time frame: Date of 10th attended postoperative therapeutic appointment, up to 30 days following initial therapeutic evaluation
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
Upper Extremity Functional Index
Time frame: Upon discharge from therapeutic services, up to one year
Patient reported outcome measure used to assess the functional impairment individuals with musculoskeletal upper limb dysfunction
1 secondary outcome
QuestionPro Post-Operative Survey using Visual Analogue Scale (VAS)
Time frame: Date of first attended postoperative therapeutic appointment, up to 15 days following surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Occupational Therapy Pre-operative Consult and Typical Pre-Operative Education in people with Flexor Tendon Rupture and Thumb Osteoarthritis, run by Methodist University, North Carolina.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 26 Sep 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Patient appointment attendance (time frame: Through completion of therapy, up to one year.). The study lists 4 primary outcomes in all. 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 26 Sep 2025.