An interventional study of Ligament Reconstruction with Allograft Ligament in Hand Injuries, Wrist Injuries and Ligament Injury, sponsored by Cedars-Sinai Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-29.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Treatment
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.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 45 is below the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
Participants will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
Procedure: Ligament Reconstruction with Allograft Ligament
Patients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Cedars-Sinai Medical Center