MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
Primary Purpose
Arthritis, Joint Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ligament reconstruction tendon interposition
Suspensionplasty with one-suture construct
Suspensionplasty with two-suture construct
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
Eligibility Criteria
Inclusion Criteria:
- Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.
Exclusion Criteria:
- To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
- Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
- Patients that are non-operative candidates due to medical comorbidities will also be excluded.
Sites / Locations
- Orlando Health
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Ligament reconstr. tendon interposition
Mini Tight rope with one-suture
Mini Tight rope with two-suture
Arm Description
Ligament reconstruction, tendon interposition.
Mini Tight rope with one suture
Mini Tight rope with two sutures
Outcomes
Primary Outcome Measures
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity
SF-36 patient survey scores
Commonly accepted functional outcome scores used to evaluate patients post-operatively
Patient satisfaction surveys
Patient-reported experiences on care received
Pinch/grip strength
the measurable ability to exert pressure with the hand, fingers, or both. It is measured by having a patient forcefully squeeze, grip, or pinch dynamometers; results are expressed in either pounds or kilograms of pressure.
Secondary Outcome Measures
Visual pain scale
Unidimensional measure of pain intensity anchored by scores of 0 ["no pain"] and 10 [worst pain imaginable] at its extremes.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02591368
Brief Title
MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
Official Title
MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Study Start Date
October 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Orlando Health, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective randomized trial aims to ascertain differences in outcome measures for the operative treatment of basilar thumb arthritis by comparing the two most common surgical treatments: LRTI and mini tightrope suspensionplasty. The Investigators will evaluate both subjective and objective data to determine if a particular surgical method offers more favorable outcomes.
Detailed Description
The study will be a prospective randomized-controlled trial comparing LRTI and mini tightrope suspensionplasty for the surgical treatment of basilar thumb arthritis. Patients meeting operative criteria who present to Level One Orthopaedics at Orlando Health will be consented for study participation. Subsequently, consented patients will be randomized into one of three treatment arms: LRTI, suspensionplasty with one-suture construct and suspensionplasty with two-suture construct. The patient will be blinded prior to the procedure; however, the performing surgeon will not be able to be blinded. The patient will become un-blinded postoperatively when the performing surgeon informs them which method was used. The investigators will then follow the patients for 5 years to assess the primary and secondary outcomes (see below) and analyze the data with an intention-to-treat method before publishing the conclusions. Follow-up visits will occur at two weeks, one month, three months, six months, one year, and five years. Outcome measures will incorporate subjective and objective measures and will include the SF-36 and Disabilities of Arm, Shoulder & Hand (DASH) questionnaires, pinch/grip strength, visual analog pain scale, patient satisfaction and postoperative complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Joint Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ligament reconstr. tendon interposition
Arm Type
Active Comparator
Arm Description
Ligament reconstruction, tendon interposition.
Arm Title
Mini Tight rope with one-suture
Arm Type
Active Comparator
Arm Description
Mini Tight rope with one suture
Arm Title
Mini Tight rope with two-suture
Arm Type
Active Comparator
Arm Description
Mini Tight rope with two sutures
Intervention Type
Procedure
Intervention Name(s)
Ligament reconstruction tendon interposition
Intervention Description
In this procedure the trapezium is removed and one of the patient's own tendons (or portion of the tendon), usually the flexor carpi radialis or abductor pollicis longus, is passed through a drill hole in the thumb metacarpal and is used to suspend the first metacarpal base.
Intervention Type
Procedure
Intervention Name(s)
Suspensionplasty with one-suture construct
Intervention Description
In this procedure the trapezium is removed and an Arthrex mini tightrope system using Fiberwire suture is drilled across the first metacarpal to the second metacarpal and is used to suspend the first metacarpal base instead of a tendon.
Intervention Type
Procedure
Intervention Name(s)
Suspensionplasty with two-suture construct
Intervention Description
In this procedure the trapezium is removed and two Arthrex mini tightrope systems using Fiberwire sutures are drilled across the first metacarpal to the second metacarpal and are used to suspend the first metacarpal base instead of a tendon.
Primary Outcome Measure Information:
Title
Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
Description
30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity
Time Frame
An average of 5 years.
Title
SF-36 patient survey scores
Description
Commonly accepted functional outcome scores used to evaluate patients post-operatively
Time Frame
On the follow-up visits
Title
Patient satisfaction surveys
Description
Patient-reported experiences on care received
Time Frame
An average of 5 years.
Title
Pinch/grip strength
Description
the measurable ability to exert pressure with the hand, fingers, or both. It is measured by having a patient forcefully squeeze, grip, or pinch dynamometers; results are expressed in either pounds or kilograms of pressure.
Time Frame
An average of 5 years.
Secondary Outcome Measure Information:
Title
Visual pain scale
Description
Unidimensional measure of pain intensity anchored by scores of 0 ["no pain"] and 10 [worst pain imaginable] at its extremes.
Time Frame
An average of 5 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.
Exclusion Criteria:
To have a history of prior surgical intervention for basilar thumb arthritis, trauma to the hand or wrist, or debilitating injury to the upper extremity.
Patients under the age of 18 or with a history of a debilitating neurologic injury, either acute or chronic, to the upper extremity will be excluded.
Patients that are non-operative candidates due to medical comorbidities will also be excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brett Lewellyn, MD
Organizational Affiliation
Orlando Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orlando Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
7944639
Citation
Henderson EB, Smith EC, Pegley F, Blake DR. Intra-articular injections of 750 kD hyaluronan in the treatment of osteoarthritis: a randomised single centre double-blind placebo-controlled trial of 91 patients demonstrating lack of efficacy. Ann Rheum Dis. 1994 Aug;53(8):529-34. doi: 10.1136/ard.53.8.529.
Results Reference
background
PubMed Identifier
15576217
Citation
Davis TR, Brady O, Dias JJ. Excision of the trapezium for osteoarthritis of the trapeziometacarpal joint: a study of the benefit of ligament reconstruction or tendon interposition. J Hand Surg Am. 2004 Nov;29(6):1069-77. doi: 10.1016/j.jhsa.2004.06.017.
Results Reference
background
PubMed Identifier
24491585
Citation
Yao J, Lashgari D. Thumb basal joint: Utilizing new technology for the treatment of a common problem. J Hand Ther. 2014 Apr-Jun;27(2):127-32; quiz 133. doi: 10.1016/j.jht.2013.12.012. Epub 2014 Jan 3.
Results Reference
background
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MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
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