Basilar Thumb Arthritis
Conditions
Brief summary
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.
Interventions
DEVICESuture Tape Reconstruction
This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
Sponsors
Henry Ford Health System
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients of Henry Ford Orthopedic Service Line * Symptomatic basilar thumb arthritis refractory to conservative management
Exclusion criteria
* Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse. * Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pinch Strength | 6 months post procedure | Pinch Strength measurements |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-UE | 6 months post procedure | PROMIS-UE scores are reported as T-scores standardized to the U.S. population (mean 50, SD 10; typical range \~15-61). Higher scores indicate better upper extremity function. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 66.2 Years STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 5 |
| other Total, other adverse events | 0 / 17 | 0 / 5 |
| serious Total, serious adverse events | 0 / 17 | 0 / 5 |
Outcome results
None listed