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Under-enrollment, was not feasible to be completed with a satisfactory sample size.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Experimental | Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. |
|
| Carpometacarpal (CMC) Standard Ligament Reconstruction | No Intervention | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suture Tape Reconstruction | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pinch Strength | Pinch Strength measurements | 6 months post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| PROMIS-UE | 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. | 6 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. Suture 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. |
| FG001 | Carpometacarpal (CMC) Standard Ligament Reconstruction | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. Suture 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pinch Strength | Pinch Strength measurements | Pinch strength was measured using a dynamometer (kg force), with higher values indicating greater strength. Due to early study termination, most participants did not reach the 6-month follow-up. No participants in the CMC suture tape group and only 2 in the standard group were evaluable. Data are limited and reported descriptively; no statistical comparisons were performed due to small sample size. | Posted | Mean | Standard Deviation | lbs | 6 months post procedure |
|
3 months was the maximum follow-up for any patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. Suture 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hardy Evans | Henry Ford Health | 313-805-7873 | hevans3@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 11, 2023 | May 20, 2025 | Prot_SAP_000.pdf |
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|
| BG001 | Carpometacarpal (CMC) Standard Ligament Reconstruction | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG001 | Carpometacarpal (CMC) Standard Ligament Reconstruction | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
|
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| Secondary | PROMIS-UE | 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. | PROMIS-UE scores were intended to be collected at pre-specified follow-up intervals. Due to early study termination, most participants did not reach the 6-month timepoint. No participants in the CMC Suture Tape group and only 2 participants in the CMC Standard group were evaluable at 6 months. Available data are reported descriptively. No formal statistical analysis was conducted due to the limited sample size. | Posted | Mean | Standard Deviation | t-score | 6 months post procedure |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | Carpometacarpal (CMC) Standard Ligament Reconstruction | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. | 0 | 5 | 0 | 5 | 0 | 5 |
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