Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

NCT ID: NCT05060900

Last Updated: 2021-09-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-30
• Study Completion Date: 2023-09-30

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.

Conditions

Hand Injuries; Wrist Injuries; Ligament Injury; Ligament Rupture; Ligament Avulsion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hand and Wrist Ligament Reconstruction with Allograft Ligament

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

Group Type: EXPERIMENTAL

Ligament Reconstruction with Allograft Ligament

Intervention Type: PROCEDURE

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

Interventions

Ligament Reconstruction with Allograft Ligament

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Kulber, MD

Director of Hand and Upper Extremity Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kulber, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Central Contacts

Michael Sun, MD

Role: CONTACT

michael.sun@cshs.org

858-414-8733

Facility Contacts

Michael Sun, MD

Role: primary

michael.sun@cshs.org

Other Identifiers

STUDY00000044

Identifier Type: -

Identifier Source: org_study_id