Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

Hand Injuries Clinical Trial

Official title:

Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05060900
• Other study ID #: STUDY00000044
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2021
• Est. completion date: September 2023

Study information

• Verified date: September 2021
• Source: Cedars-Sinai Medical Center
• Contact: Michael Sun, MD
• Phone: 858-414-8733
• Email: michael.sun[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 (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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 2023
• Est. primary completion date: September 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hand Injuries
• Ligament Injury
• Ligament Rupture
• Rupture
• Wounds and Injuries
• Wrist Injuries

Intervention

Procedure:
• Ligament Reconstruction with Allograft Ligament
Patients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Primary	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.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Primary	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.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Primary	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.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Primary	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.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
Primary	Change from baseline in wrist and finger radiographs.	Radiographic images obtained can help indicate the success of surgery by demonstrating joint stability.	Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year