Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

Cedars-Sinai Medical Center

Status: Unknown

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

Treatments: Procedure: Ligament Reconstruction with Allograft Ligament

Study type: Interventional

Funder types: Other

Identifiers

NCT05060900

STUDY00000044

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

45 participants in 1 patient group

Hand and Wrist Ligament Reconstruction with Allograft Ligament

Experimental group

Description:

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

Treatment:

Procedure: Ligament Reconstruction with Allograft Ligament