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Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

Primary Purpose

Hand Injuries, Wrist Injuries, Ligament Injury

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ligament Reconstruction with Allograft Ligament
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injuries focused on measuring hand ligament injury, wrist ligament injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hand and Wrist Ligament Reconstruction with Allograft Ligament

Arm Description

Participants will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Change from baseline in wrist and finger radiographs.
Radiographic images obtained can help indicate the success of surgery by demonstrating joint stability.

Secondary Outcome Measures

Full Information

First Posted
September 18, 2021
Last Updated
September 18, 2021
Sponsor
Cedars-Sinai Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05060900
Brief Title
Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
Official Title
Hand Ligament Reconstructions With Knee Collateral Ligament Allografts
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injuries, Wrist Injuries, Ligament Injury, Ligament Rupture, Ligament Avulsion
Keywords
hand ligament injury, wrist ligament injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients enrolled in the study will undergoing their ligament reconstruction procedure with allograft ligament.
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hand and Wrist Ligament Reconstruction with Allograft Ligament
Arm Type
Experimental
Arm Description
Participants will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
Intervention Type
Procedure
Intervention Name(s)
Ligament Reconstruction with Allograft Ligament
Intervention Description
Patients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
Primary Outcome Measure Information:
Title
Change from baseline in functional outcome, as measured by the quick Disabilities of the Arm, Shoulder and Hand (qDASH) questionnaire
Description
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
Title
Change from baseline in pain, as measured by the Visual Analog Scale (VAS)
Description
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
Title
Change from baseline in key pinch strength, as measured with a pinch gauge.
Description
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
Title
Change from baseline in grip strength, as measured with a Jamar hand dynamometer.
Description
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
Title
Change from baseline in wrist and finger range of motion angles.
Description
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
Title
Change from baseline in wrist and finger radiographs.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Sun, MD
Phone
858-414-8733
Email
michael.sun@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Kulber, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sun, MD
Email
michael.sun@cshs.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

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