Clinical trial NCT02591368: 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
Overall status: TERMINATED
Phase: NA
Conditions: Arthritis
Joint Diseases
Lead sponsor: Orlando Health, Inc.
Sponsor class: OTHER
First posted: 2015-10-29
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disabilities of Arm, Shoulder & Hand (DASH) questionnaire
timeFrame: An average of 5 years.
measure: SF-36 patient survey scores
timeFrame: On the follow-up visits
measure: Patient satisfaction surveys
timeFrame: An average of 5 years.
measure: Pinch/grip strength
timeFrame: An average of 5 years.
Secondary outcomes:
measure: Visual pain scale
timeFrame: An average of 5 years.
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Orlando Health
state: Florida
Study officials:
affiliation: Orlando Health
name: Brett Lewellyn, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.