MiniTightRope Suspensionplasty Compared With LRTI for the Treatment of Basilar Thumb Arthritis



Status:Recruiting
Conditions:Arthritis, Orthopedic
Therapuetic Areas:Rheumatology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/4/2017
Start Date:October 2015
End Date:October 2021
Contact:Brett Lewellyn, MD
Email:brett.lewellyn@orlandohealth.com
Phone:407-643-0839

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MiniTightRope Suspensionplasty Compared With Ligamentous Reconstruction Tendon Interposition for the Treatment of Basilar Thumb Arthritis. A Randomized Clinical Trial

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.

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.

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.
We found this trial at
1
site
24 Sturtevant St
Orlando, Florida 32806
Phone: 321-843-5390
?
mi
from
Orlando, FL
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