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Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair

Primary Purpose

Distal Radius Fracture, Tendon Rupture

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Versawrap membrane
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Distal Radius Fracture

Eligibility Criteria

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

Inclusion Criteria:

  • Cognitively able to converse in English or in native language supported by a certified medical interpreter;
  • Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system.

Exclusion Criteria:

  • open injury;
  • concomitant injury to the contralateral wrist;
  • history of flexor tendon repair involving one or both hands or wrists;
  • use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively;
  • concomitant fracture / injury to the thumb or index finger of one or both hands;
  • concomitant carpal tunnel release.

Sites / Locations

  • University of Colorado Health HospitalRecruiting
  • Denver Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Versawrap

No Versawrap

Arm Description

Outcomes

Primary Outcome Measures

Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.
Range of Motion: Thumb and Index Finger
Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers
Range of Motion: Wrist
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.

Secondary Outcome Measures

Complications
Incidence of any of the following perioperative complications: infection, neurovascular injury, tendon rupture, hardware failure, delayed fracture union, fracture nonunion, fracture malunion, or revision surgery
Patient-Rated Wrist Evaluation (PRWE)
The Patient-Rated Wrist Evaluation (PRWE) measures pain and wrist function. Possible scores range from 0-100, with a higher score indicating a worse outcome.
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) measures limb function and disability. Possible scores range from 0-100, with a higher score indicating a worse outcome (more severe disability).
Visual Analog Scale (VAS) pain scores
The Visual Analog Scale measures patient reported pain using a 100mm scale. Possible scores range from 0-100, with higher scores indicating more severe pain.
Subjective Reporting Specific to Tendon Function
The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology
Tendons in the volar forearm will be directly visualized with ultrasound and their physical appearance will be grossly described. For this outcome measure, the number of participants with a healthy tendon, as determined by the physician, will be reported.
Key Pinch
Standardized clinical examination (relative to wrist and digital positioning) of key pinch.
Three-Jaw Pinch
Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.
Grip Strength
Standardized clinical examination (relative to wrist and digital positioning) of grip strength.
Soong Classification
Routine (3-view) radiographs of the injured wrist to document Soong grading of distal radius plate positioning. Soong et al (2011) proposed the Soong classification to classify palmar prominence at the watershed line, where flexor tendons lie closest to the plate. Classifications are as follows: 0: Plates do not extend volar to the watershed line; 1: Plates are volar to the line, but proximal to the volar rim; and 2: Plates are directly on or distal to the volar rim.

Full Information

First Posted
July 14, 2021
Last Updated
March 21, 2023
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04976335
Brief Title
Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair
Official Title
Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

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

5. Study Description

Brief Summary
The investigators will be evaluating the use of versawrap in the setting of distal radius fractures by placing membrane between plate and flexor tendons. Investigators will then evaluate tendon gliding morphology and number of tendon ruptures

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Tendon Rupture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Versawrap
Arm Type
Active Comparator
Arm Title
No Versawrap
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Versawrap membrane
Intervention Description
Versawrap membrane will be placed between distal radius plate and flexor tendons
Primary Outcome Measure Information:
Title
Range of Motion: Thumb Interphalangeal and Index Finger Distal Interphalangeal Joints
Description
Standardized clinical examination (relative to wrist and digital positioning): active and passive range of motion for thumb interphalangeal and index finger distal interphalangeal joints.
Time Frame
6 months
Title
Range of Motion: Thumb and Index Finger
Description
Standardized clinical examination (relative to wrist and digital positioning): active and passive composite digital range of motion for thumb and index fingers
Time Frame
6 months
Title
Range of Motion: Wrist
Description
Standardized clinical examination (relative to wrist and digital positioning): active and passive wrist range of motion.
Time Frame
6 months
Title
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Excursion
Description
Tendons in the volar forearm will be directly visualized with ultrasound. The distance the tendons are able to travel (excursion) within the forearm will be reported.
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Complications
Description
Incidence of any of the following perioperative complications: infection, neurovascular injury, tendon rupture, hardware failure, delayed fracture union, fracture nonunion, fracture malunion, or revision surgery
Time Frame
6 months
Title
Patient-Rated Wrist Evaluation (PRWE)
Description
The Patient-Rated Wrist Evaluation (PRWE) measures pain and wrist function. Possible scores range from 0-100, with a higher score indicating a worse outcome.
Time Frame
6 Months
Title
Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH)
Description
The Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) measures limb function and disability. Possible scores range from 0-100, with a higher score indicating a worse outcome (more severe disability).
Time Frame
6 Months
Title
Visual Analog Scale (VAS) pain scores
Description
The Visual Analog Scale measures patient reported pain using a 100mm scale. Possible scores range from 0-100, with higher scores indicating more severe pain.
Time Frame
6 Months
Title
Subjective Reporting Specific to Tendon Function
Description
The number of participants reporting the following: 1) pain with resist pinch, 2) perceived tendon triggering, catching, or locking
Time Frame
6 Months
Title
Ultrasound Assessment of Flexor Pollicis Longus and Index Finger Flexor Digitorum Profundus Tendon Morphology
Description
Tendons in the volar forearm will be directly visualized with ultrasound and their physical appearance will be grossly described. For this outcome measure, the number of participants with a healthy tendon, as determined by the physician, will be reported.
Time Frame
6 Months
Title
Key Pinch
Description
Standardized clinical examination (relative to wrist and digital positioning) of key pinch.
Time Frame
6 Months
Title
Three-Jaw Pinch
Description
Standardized clinical examination (relative to wrist and digital positioning of three-jaw pinch.
Time Frame
6 Months
Title
Grip Strength
Description
Standardized clinical examination (relative to wrist and digital positioning) of grip strength.
Time Frame
6 Months
Title
Soong Classification
Description
Routine (3-view) radiographs of the injured wrist to document Soong grading of distal radius plate positioning. Soong et al (2011) proposed the Soong classification to classify palmar prominence at the watershed line, where flexor tendons lie closest to the plate. Classifications are as follows: 0: Plates do not extend volar to the watershed line; 1: Plates are volar to the line, but proximal to the volar rim; and 2: Plates are directly on or distal to the volar rim.
Time Frame
6 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cognitively able to converse in English or in native language supported by a certified medical interpreter; Diagnosed with a closed, distal radius fracture treated with open reduction and internal fixation using a volar distal radius plating system. Exclusion Criteria: open injury; concomitant injury to the contralateral wrist; history of flexor tendon repair involving one or both hands or wrists; use of a trans-carpal fixation device (bridge plate or external fixator) that would preclude wrist motion post-operatively; concomitant fracture / injury to the thumb or index finger of one or both hands; concomitant carpal tunnel release.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jason L Koerner, MD
Phone
303-724-8472
Email
Jason.koerner@cuanschutz.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fraser Leversedge, MD
Organizational Affiliation
University of Colorado Denver | Anschutz
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason L Koerner, MD
Phone
720-848-0000
Facility Name
Denver Health Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jason L Koerner, MD
Phone
303-436-6000

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair

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