Arthritis, Joint Diseases
Conditions
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.
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.
PROCEDURESuspensionplasty with one-suture construct
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.
PROCEDURESuspensionplasty with two-suture construct
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.
Sponsors
Orlando Health, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disabilities of Arm, Shoulder & Hand (DASH) questionnaire | An average of 5 years. | 30-item questionnaire designed to measure physical function and symptoms in people with musculoskeletal disorders of the upper extremity |
| SF-36 patient survey scores | On the follow-up visits | Commonly accepted functional outcome scores used to evaluate patients post-operatively |
| Patient satisfaction surveys | An average of 5 years. | Patient-reported experiences on care received |
| Pinch/grip strength | An average of 5 years. | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual pain scale | An average of 5 years. | Unidimensional measure of pain intensity anchored by scores of 0 \[no pain\] and 10 \[worst pain imaginable\] at its extremes. |
Countries
United States
Outcome results
None listed