Clinical trial NCT05060900: Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
Official title: Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hand Injuries
Wrist Injuries
Ligament Injury
Ligament Rupture
Ligament Avulsion
Keywords: hand ligament injury, wrist ligament injury
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients enrolled in the study will undergoing their ligament reconstruction procedure with allograft ligament.
Primary purpose: TREATMENT

Brief 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 (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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
measure: Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
measure: Change from baseline in key pinch strength, as measured with a pinch gauge.
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
measure: Change from baseline in grip strength, as measured with a Jamar hand dynamometer.
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
measure: Change from baseline in wrist and finger range of motion angles.
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
measure: Change from baseline in wrist and finger radiographs.
timeFrame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: David Kulber, MD
role: PRINCIPAL_INVESTIGATOR
References: