Wrist InjuriesDRUJNCT02591810
Treatment Options for Acute Distal Radioulnar Joint Instability
A study testing Serial casting/splinting, Percutaneous fixation and Foveal repair in people with Wrist Injuries, run by Orlando Health, Inc..
Trial summary
This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Injuries
- What is being tested?
- Serial casting/splinting, Percutaneous fixation and Foveal repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 5 Nov 2015to 9 Nov 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients treated at Orlando Regional Medical Center,
- 18 years or older,
- Have an acute (less than 4 week old) injury with instability of the DRUJ.
Who cannot join
- Younger than 18 years old,
- Patients with an injury over 4 weeks old,
- Previous history of ipsilateral upper extremity trauma,
- Functional deficit,
- Those who are unable to complete postoperative assessments. -
About this study
Official title: Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.
Read the detailed description
This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.
- Conditions
- Wrist Injuries
- Being tested
- Serial casting/splinting, Percutaneous fixation, Foveal repair
- Medical subject headings
- Wrist Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial casting/splintingProcedure or surgery
Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
Percutaneous fixationProcedure or surgery
Injury is treated by the percutaneous placement of Kirschner wires to promote healing. This is an invasive procedure, involving the placement of Kirschner wires to stabilize the wrist.
Foveal repairProcedure or surgery
Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Serial Casting | Active comparator | Participants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention. Receives: Procedure: Serial casting/splinting |
| Kirschner wires | Active comparator | Participants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically. Receives: Procedure: Percutaneous fixation |
| Foveal repair | Active comparator | Participants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention. Receives: Procedure: Foveal repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and assessment of DASH scores.
To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score.
Measured: Up to 5 years.
Secondary outcomes (1)
Visual Analog Pain scale
Patient will be asked to describe level on pain on a 10cm scale, in 1 cm increments, from 0 to 10. 0 equals no pain, 10 equals the worst pain.
Measured: Up to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start5 Nov 2015
- Primary completion5 Nov 2016
- Study completion9 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orlando Health, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Lewellyn, Orlando Health, Inc.
- Investigators
- Tara Roberts, BS, Study chair, Orlando Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02591810
- Sponsor's protocol ID
- 15.041.04
- Acronym
- DRUJ
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2015
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Treatment Options for Acute Distal Radioulnar Joint Instability: A Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02591810
- Acronym / sponsor ID
- DRUJ / 15.041.04
- Conditions
- Wrist Injuries
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Orlando Health, Inc.University, hospital or other
- Study start
- 5 Nov 2015 (actual)
- Primary completion
- 5 Nov 2016 (actual)
- Study completion
- 9 Nov 2016 (actual)
- First posted
- 30 Oct 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.
This prospective randomized control trial (PRCT) aims to compare the outcome of three treatments for acute distal radioulnar joint (DRUJ) injury with instability with or without concomitant distal radius fractures: serial splinting/casting with the hand and wrist in the most stable position for DRUJ reduction vs percutaneous DRUJ fixation with Kirschner wires vs open anatomic foveal repair of Triangular fibrocartilage complex (TFCC ) ligaments.
Detailed description
This is a prospective randomized control trial comparing three methods of treatment for acute DRUJ instability with or without concomitant distal radius fracture. Upon determination of residual DRUJ instability either preoperatively or intraoperatively after distal radius fracture fixation, patients will be randomized into one of the three treatment arms of the study: nonoperative treatment with immobilization, percutaneous DRUJ fixation with Kirschner wires, and open anatomic foveal repair of Triangular fibrocartilage complex TFCC ligaments with suture. Those patients undergoing Kirschner wire fixation will have their pins pulled in the clinic setting six weeks postoperatively. Outcomes will be assessed at follow up visits using the subjective and objective measures and clinical assistants will be blinded as to the treatment type. Physician-based assessment of functional outcome with be assessed using the Disability of the Arm, Shoulder and Hand (DASH) score and Mayo Wrist scores, as well as independent assessment of DRUJ instability, ROM, and grip strength. Patient-based assessment will include visual analog pain scores as well as satisfaction questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Serial Casting | Active comparator | Procedure: Serial casting/splintingParticipants will receive the intervention of the placement of serial casting/splinting for the injured wrist. This is not a surgical intervention. |
| Kirschner wires | Active comparator | Procedure: Percutaneous fixationParticipants will receive the intervention of percutaneous fixation with Kirschner wires for the injured wrist. This will be performed surgically. |
| Foveal repair | Active comparator | Procedure: Foveal repairParticipants will receive the intervention of open anatomic foveal repair of the ligaments of the injured wrist. This is a surgical intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients treated at Orlando Regional Medical Center,
- 18 years or older,
- Have an acute (less than 4 week old) injury with instability of the DRUJ.
Key exclusion criteria (5 listed)
- Younger than 18 years old,
- Patients with an injury over 4 weeks old,
- Previous history of ipsilateral upper extremity trauma,
- Functional deficit,
- Those who are unable to complete postoperative assessments. -
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 |
|---|---|---|
| Serial casting/splintingSerial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs. | Procedure or surgery | Serial Casting |
| Percutaneous fixationInjury is treated by the percutaneous placement of Kirschner wires to promote healing. This is an invasive procedure, involving the placement of Kirschner wires to stabilize the wrist. | Procedure or surgery | Kirschner wires |
| Foveal repairInjury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure. | Procedure or surgery | Foveal repair |
Primary outcome
Evaluation and assessment of DASH scores.
Time frame: Up to 5 years.
To compare the outcomes of the three treatment arms for acute DRUJ instability by assessment with the Disabilities of the Arm, Shoulder, and Hand (DASH) Score.
1 secondary outcome
Visual Analog Pain scale
Time frame: Up to 5 years.
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 5 Aug 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. This study is not recruiting at the moment.
Tara Roberts, BS study chair
Orlando Health
Questions about this trial
What is this clinical trial studying?
A study testing Serial casting/splinting, Percutaneous fixation and Foveal repair in people with Wrist Injuries, run by Orlando Health, Inc..
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 3 inclusion and 5 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 5 Aug 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?
Evaluation and assessment of DASH scores. (time frame: Up to 5 years.). 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 5 Aug 2025.