Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

September 18, 2021 updated by: David Kulber, MD, Cedars-Sinai Medical Center

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hand and Wrist Ligament Reconstruction with Allograft Ligament
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
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.
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.
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.
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.
Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
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.
Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year
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.
Baseline, post-surgery 6 week, post-surgery 6 month, post-surgery 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cedars-Sinai Medical Center

Investigators

  • Principal Investigator: David Kulber, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 18, 2021

First Submitted That Met QC Criteria

September 18, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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