Perilunate InjuryNCT05824078
Perilunate Management
A study testing Arthroscopic surgery and Open Surgery in people with Perilunate Injury, run by Emory University at 1 site in United States.
Trial summary
Perilunate injuries can be debilitating injuries that involve the carpus. These can limit patients' functionality both acutely and long-term. Not only do their potential for nerve injury increase risk of lasting weakness and chronic pain, but their complex surrounding involving the carpus also leads to potential for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perilunate Injury
- What is being tested?
- Arthroscopic surgery and Open Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jul 2023to 24 Oct 2025
- 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
- All adult patients (18 years old and older).
- Patients requiring surgical intervention for a perilunate injury will be consented and then randomly allocated to either open or arthroscopic surgery.
Who cannot join
- Prisoners will not be included in this study.
- Patients younger than 18 years old and pregnant patients will be excluded from this review.
- Patients who require a specific surgical approach for their treatment cannot be randomly allocated to one of the study arms, so they will be excluded from this study.
- The study will not include data from minors, cognitively impaired individuals, or individuals who are vulnerable to coercion or under the influence.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcomes of Perilunate Injury Management: Open vs Arthroscopic Approach
Perilunate injuries can be debilitating injuries that involve the carpus. These can limit patients' functionality both acutely and long-term. Not only do their potential for nerve injury increase risk of lasting weakness and chronic pain, but their complex surrounding involving the carpus also leads to potential for misalignment when healing. The approach for treating perilunate injuries often relies on internal fixation, prompting the need for surgery. However, there is no clear recommendation for whether to pursue open or arthroscopic surgery as both offer benefits and pose risks.
The aim of this study is to determine the similarities and differences in outcomes for management of perilunate injuries.
Read the detailed description
Perilunate injuries are those that affect the wrist, which can be debilitating to patients. Often, these injuries require surgical treatment, which can either be performed open or arthroscopically. There is currently no consensus on which approach offers better outcomes. Therefore, this study will allocate patients who require surgical treatment of perilunate injuries to either open or arthroscopic surgical intervention to compare their outcomes. The results will offer insight into the compromises made with each surgical approach and create a foundation that orthopedic surgeons can leverage to decide how to manage a patient to ensure the best possible outcomes.
This study will involve 12 patients who were identified as having perilunate injuries requiring orthopedic surgical treatment. Their participation will involve consenting to be randomly allocated to the surgical approach, and they will be asked to complete commonly used orthopedic surveys (e.g., DASH score) that are used to evaluate the functional healing of their injury. They will be followed up for up to 1 year after their surgery. A chart review will be conducted to follow their progress and surgical outcomes.
Patients will be recruited from Grady Memorial Hospital. No specimens will be collected or banked for this study.
- Conditions
- Perilunate Injury
- Being tested
- Arthroscopic surgery, Open Surgery
- Keywords
- Carpus, Arthroscopy, Open surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic surgeryProcedure or surgery
Arthroscopic approach involves smaller incision, offering less traumatic procedures and faster healing, but due to the limited space in this closed field with significant vasculature and nerve distribution, scoping has increased risk for iatrogenic injuries.
Open SurgeryProcedure or surgery
The open approach requires dissection of capsuloligamentous structures, which can lead to stiffness of the joint due to capsular scarring as it heals. However, it offers good visual field when treating the injury, allowing maneuverability to avoid iatrogenic soft tissue injuries.
| Study group | Role | What they receive |
|---|---|---|
| Open procedure | Active comparator | The study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure.
Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery.
Both surgical approaches are well-recognized, common, standard-of-care procedures. Receives: Procedure: Open Surgery |
| Arthroscopic Procedure | Active comparator | The study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure.
Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery.
Both surgical approaches are well-recognized, common, standard-of-care procedures. Receives: Procedure: Arthroscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numeric Rating Scale (NRS)
The numeric rating scale is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
Measured: 12 weeks post-operation
Secondary outcomes (1)
Range of motion
Range of motion (ROM) means the extent or limit to which a part of the body can be moved around a joint or a fixed point; the totality of movement a joint is capable of doing. A range of motion test, also called a flexibility test, is used to measure the degree of movement of a joint. A goniometer is an instrument that is used to measure the range of motion of a joint.
Measured: 12 weeks post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start3 Jul 2023
- Primary completion24 Oct 2025
- Study completion24 Oct 2025
Why it stopped: Study was terminated due to slow enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perilunate InjuryStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Zelenski, Emory University
- Investigators
- Nicole Zelenski, MD, Principal investigator, Assistant ProfessorEric R Wagner, MD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824078
- Sponsor's protocol ID
- STUDY00005088
- Other IDs
- 2025P013453
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2023
- Last updated
- 30 Apr 2026
- 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 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Perilunate Injury Management: Open vs Arthroscopic Approach
- ClinicalTrials.gov ID
- NCT05824078
- Acronym / sponsor ID
- STUDY00005088
- Conditions
- Perilunate Injury
- Keywords
- Carpus, Arthroscopy, Open surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to slow enrollment.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 24 Oct 2025 (actual)
- Study completion
- 24 Oct 2025 (actual)
- First posted
- 21 Apr 2023 (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.
Perilunate injuries can be debilitating injuries that involve the carpus. These can limit patients' functionality both acutely and long-term. Not only do their potential for nerve injury increase risk of lasting weakness and chronic pain, but their complex surrounding involving the carpus also leads to potential for misalignment when healing. The approach for treating perilunate injuries often relies on internal fixation, prompting the need for surgery. However, there is no clear recommendation for whether to pursue open or arthroscopic surgery as both offer benefits and pose risks.
The aim of this study is to determine the similarities and differences in outcomes for management of perilunate injuries.
Detailed description
Perilunate injuries are those that affect the wrist, which can be debilitating to patients. Often, these injuries require surgical treatment, which can either be performed open or arthroscopically. There is currently no consensus on which approach offers better outcomes. Therefore, this study will allocate patients who require surgical treatment of perilunate injuries to either open or arthroscopic surgical intervention to compare their outcomes. The results will offer insight into the compromises made with each surgical approach and create a foundation that orthopedic surgeons can leverage to decide how to manage a patient to ensure the best possible outcomes.
This study will involve 12 patients who were identified as having perilunate injuries requiring orthopedic surgical treatment. Their participation will involve consenting to be randomly allocated to the surgical approach, and they will be asked to complete commonly used orthopedic surveys (e.g., DASH score) that are used to evaluate the functional healing of their injury. They will be followed up for up to 1 year after their surgery. A chart review will be conducted to follow their progress and surgical outcomes.
Patients will be recruited from Grady Memorial Hospital. No specimens will be collected or banked for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open procedure | Active comparator | Procedure: Open SurgeryThe study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure. Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery. Both surgical approaches are well-recognized, common, standard-of-care procedures. |
| Arthroscopic Procedure | Active comparator | Procedure: Arthroscopic surgeryThe study intervention involved in this project is the randomized allocation of the patient who requires surgical treatment of their perilunate injury to receive either an open or arthroscopic approach for the procedure. Once the patient is in agreement to have surgery and has consented to partake in the study, they will be randomly allocated to either open perilunate surgery or arthroscopic perilunate surgery. Both surgical approaches are well-recognized, common, standard-of-care procedures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients (18 years old and older).
- Patients requiring surgical intervention for a perilunate injury will be consented and then randomly allocated to either open or arthroscopic surgery.
Key exclusion criteria (4 listed)
- Prisoners will not be included in this study.
- Patients younger than 18 years old and pregnant patients will be excluded from this review.
- Patients who require a specific surgical approach for their treatment cannot be randomly allocated to one of the study arms, so they will be excluded from this study.
- The study will not include data from minors, cognitively impaired individuals, or individuals who are vulnerable to coercion or under the influence.
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 |
|---|---|---|
| Arthroscopic surgeryArthroscopic approach involves smaller incision, offering less traumatic procedures and faster healing, but due to the limited space in this closed field with significant vasculature and nerve distribution, scoping has increased risk for iatrogenic injuries. | Procedure or surgery | Arthroscopic Procedure |
| Open SurgeryThe open approach requires dissection of capsuloligamentous structures, which can lead to stiffness of the joint due to capsular scarring as it heals. However, it offers good visual field when treating the injury, allowing maneuverability to avoid iatrogenic soft tissue injuries. | Procedure or surgery | Open procedure |
Primary outcome
Pain Numeric Rating Scale (NRS)
Time frame: 12 weeks post-operation
The numeric rating scale is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. The most common form of the NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.
1 secondary outcome
Range of motion
Time frame: 12 weeks post-operation
Results and safety
The study was stopped early (reason given: Study was terminated due to slow enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Perilunate Injury
RecruitingObservational study
The Canadian Prospective Pragmatic Perilunate Outcomes Trial
Wrist Injuries, Carpal Bone Fracture
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.
Nicole Zelenski, MD principal investigator
Assistant Professor
Eric R Wagner, MD principal investigator
Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic surgery and Open Surgery in people with Perilunate Injury, run by Emory University at 1 site in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 stopped early (reason given: Study was terminated due to slow enrollment.). Results are not available in the source record.
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?
Pain Numeric Rating Scale (NRS) (time frame: 12 weeks post-operation). 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 30 Apr 2026.