MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedAugust 5, 2025
July 1, 2025
3 years
October 26, 2015
July 31, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
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
An average of 5 years.
SF-36 patient survey scores
Commonly accepted functional outcome scores used to evaluate patients post-operatively
On the follow-up visits
Patient satisfaction surveys
Patient-reported experiences on care received
An average of 5 years.
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.
An average of 5 years.
Secondary Outcomes (1)
Visual pain scale
An average of 5 years.
Study Arms (3)
Ligament reconstr. tendon interposition
ACTIVE COMPARATORLigament reconstruction, tendon interposition.
Mini Tight rope with one-suture
ACTIVE COMPARATORMini Tight rope with one suture
Mini Tight rope with two-suture
ACTIVE COMPARATORMini Tight rope with two sutures
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Radiographically diagnosed Stage II-IV basilar thumb arthritis as described by the Eaton and Littler classification system on either the right or left hand.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Orlando Health
Orlando, Florida, 32806, United States
Related Publications (3)
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.
PMID: 7944639BACKGROUNDDavis 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.
PMID: 15576217BACKGROUNDYao 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.
PMID: 24491585BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brett Lewellyn, MD
Orlando Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 29, 2015
Study Start
October 1, 2015
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
August 5, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share