Hand InjuriesNCT05060900
Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
A study testing Ligament Reconstruction with Allograft Ligament in people with Hand Injuries and Wrist Injuries, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hand Injuries, Wrist Injuries, Ligament Injury
- What is being tested?
- Ligament Reconstruction with Allograft Ligament
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2021to Sep 2023
- 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
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Have symptomatic injuries to either their finger PIP collateral ligaments, thumb UCL ligaments, or wrist SL ligaments and have failed non-operative management for the above ligament injuries (thus eligible for operative reconstruction)
- Age over 18 years
Who cannot join
- Presence of any other current injury in that limb
- Presence of advanced arthrosis in that limb
- Presence of fixed joint deformity in that limb
- Presence of instability in that limb due to bony or articular instability
- Presence of instability in that limb due to inflammatory arthrosis
- Is under 18 years of age
- Lacks the capacity to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Michael Sun, MD, michael.sun@cshs.org
About this study
The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft (patients' own tissue) for the reconstruction. We believe that the use of allograft ligaments in reconstruction may eliminate the pain associated with procuring the patients' own tissue for the procedure, and prove to be a viable and preferred alternative to the multiple techniques currently used.
The main procedures of this study include wrist and hand ligament reconstruction surgery (for wrist scapholunate (SL) ligaments, thumb ulnar collateral ligaments (UCL), and finger proximal interphalangeal (PIP) joint collateral ligaments) using allograft ligament, and subsequent follow up appointments where measurements and questionnaires will be completed to evaluate how hand function is doing after surgery.
- Being tested
- Ligament Reconstruction with Allograft Ligament
- Keywords
- hand ligament injury, wrist ligament injury
- Medical subject headings
- Hand Injuries, Wrist Injuries, Fractures, Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ligament Reconstruction with Allograft LigamentProcedure or surgery
Patients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
| Study group | Role | What they receive |
|---|---|---|
| Hand and Wrist Ligament Reconstruction with Allograft Ligament | Experimental | Participants will undergo surgery for hand and wrist ligament reconstruction using allograft ligament. Receives: Procedure: Ligament Reconstruction with Allograft Ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
The qDASH questionnaire asks about symptoms of upper extremity disability as well as the ability to perform certain activities. It generates a score from 0 to 100, with higher scores indicating greater severity of disability.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
The VAS generates a scale from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Change from baseline in key pinch strength, as measured with a pinch gauge.
A pinch gauge is a device that measures key pinch strength in units of pounds or Newtons.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Change from baseline in grip strength, as measured with a Jamar hand dynamometer.
A Jamar hand dynamometer is a device that measures grip strength in units of pounds or Newtons.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Change from baseline in wrist and finger range of motion angles.
Range of motion to be assessed includes wrist extension, wrist flexion, wrist ulnar deviation, wrist radial deviation, finger proximal interphalangeal joint flexion and extension, thumb metacarpophalangeal joint flexion and extension, thumb abduction and adduction.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Change from baseline in wrist and finger radiographs.
Radiographic images obtained can help indicate the success of surgery by demonstrating joint stability.
Measured: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study startSep 2021 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All patients enrolled in the study will undergoing their ligament reconstruction procedure with allograft ligament.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Kulber, MD, Cedars-Sinai Medical Center
- Investigators
- David Kulber, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060900
- Sponsor's protocol ID
- STUDY00000044
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 29 Sep 2021
- Results posted
- 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 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
- ClinicalTrials.gov ID
- NCT05060900
- Acronym / sponsor ID
- STUDY00000044
- Keywords
- hand ligament injury, wrist ligament injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Sep 2021 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 29 Sep 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.
The purpose of this study is to review the clinical outcomes following hand ligament reconstruction surgery using allograft (cadaveric) knee collateral ligaments. Currently, there is no standard procedure or devices used for hand ligament reconstruction surgery, although most techniques use some form of autograft (patients' own tissue) for the reconstruction. We believe that the use of allograft ligaments in reconstruction may eliminate the pain associated with procuring the patients' own tissue for the procedure, and prove to be a viable and preferred alternative to the multiple techniques currently used.
The main procedures of this study include wrist and hand ligament reconstruction surgery (for wrist scapholunate (SL) ligaments, thumb ulnar collateral ligaments (UCL), and finger proximal interphalangeal (PIP) joint collateral ligaments) using allograft ligament, and subsequent follow up appointments where measurements and questionnaires will be completed to evaluate how hand function is doing after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients enrolled in the study will undergoing their ligament reconstruction procedure with allograft ligament.
| Arm | Type | Receives |
|---|---|---|
| Hand and Wrist Ligament Reconstruction with Allograft Ligament | Experimental | Procedure: Ligament Reconstruction with Allograft LigamentParticipants will undergo surgery for hand and wrist ligament reconstruction using allograft ligament. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Have symptomatic injuries to either their finger PIP collateral ligaments, thumb UCL ligaments, or wrist SL ligaments and have failed non-operative management for the above ligament injuries (thus eligible for operative reconstruction)
- Age over 18 years
Key exclusion criteria (7 listed)
- Presence of any other current injury in that limb
- Presence of advanced arthrosis in that limb
- Presence of fixed joint deformity in that limb
- Presence of instability in that limb due to bony or articular instability
- Presence of instability in that limb due to inflammatory arthrosis
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 |
|---|---|---|
| Ligament Reconstruction with Allograft LigamentPatients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament. | Procedure or surgery | Hand and Wrist Ligament Reconstruction with Allograft Ligament |
Primary outcome
Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
The qDASH questionnaire asks about symptoms of upper extremity disability as well as the ability to perform certain activities. It generates a score from 0 to 100, with higher scores indicating greater severity of disability.
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
The VAS generates a scale from 0 to 100 with 0 indicating no pain and higher scores indicating greater pain.
Change from baseline in key pinch strength, as measured with a pinch gauge.
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
A pinch gauge is a device that measures key pinch strength in units of pounds or Newtons.
Change from baseline in grip strength, as measured with a Jamar hand dynamometer.
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
A Jamar hand dynamometer is a device that measures grip strength in units of pounds or Newtons.
Change from baseline in wrist and finger range of motion angles.
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Range of motion to be assessed includes wrist extension, wrist flexion, wrist ulnar deviation, wrist radial deviation, finger proximal interphalangeal joint flexion and extension, thumb metacarpophalangeal joint flexion and extension, thumb abduction and adduction.
Change from baseline in wrist and finger radiographs.
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Radiographic images obtained can help indicate the success of surgery by demonstrating joint stability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- 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.
David Kulber, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ligament Reconstruction with Allograft Ligament in people with Hand Injuries and Wrist Injuries, run by Cedars-Sinai Medical Center 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 29 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sun, MD (858-414-8733, michael.sun@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire (time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year). The study lists 6 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 29 Sep 2021.