Hand Ligament Reconstructions With Knee Collateral Ligament Allografts

NCT05060900 | Unknown

• 1 other identifier: STUDY00000044
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

hand ligament injury, wrist ligament injury

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Hand and Wrist Ligament Reconstruction with Allograft Ligament

EXPERIMENTAL

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

Procedure: Ligament Reconstruction with Allograft Ligament

Interventions

Ligament Reconstruction with Allograft Ligament PROCEDURE

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

Hand and Wrist Ligament Reconstruction with Allograft Ligament

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Hand Injuries; Wrist Injuries; Fractures, Avulsion

Condition Hierarchy (Ancestors)

Wounds and Injuries; Arm Injuries; Fractures, Bone

Study Officials

• David Kulber, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Sun, MD

CONTACT

858-414-8733; michael.sun@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Hand and Upper Extremity Surgery

Model Details: All patients enrolled in the study will undergoing their ligament reconstruction procedure with allograft ligament.

Study Record Dates

• First Submitted: September 18, 2021
• First Posted: September 29, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)