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Carpometacarpal osteoarthritis (CMC OA) is a prevalent and disabling disease. Trapeziectomy with ligament reconstruction and tendon interposition (LRTI), the most frequently performed procedure for CMC OA, requires prolonged postoperative immobilization which limits patients' abilities to perform Activities of Daily Life (ADLs) and to work. Trapezium excision and internal brace (IB) stabilization is a largely unstudied novel alternative to LRTI which has demonstrated encouraging short-term clinical outcomes and allows an expedited return to work/activity. In this feasibility and pilot grant application, our overall objective is to investigate critical questions to inform the planning of a definitive randomized controlled trial (RCT) comparing IB and LRTI for patients with CMC OA. Our central hypothesis is that a prospective RCT comparing LRTI and IB is feasible, and that IB will produce superior patient-reported outcomes to LRTI at 6 weeks and 3 months with an expedited return to work/activity. Our specific aims are to (1) Establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining the follow-up retention rate, (2) Estimate effect sizes and variability in outcomes for planning a definitive RCT, and (3) Characterize objective clinical outcomes (thumb range of motion, grip/pinch strength, radiographic outcomes, complications/need for additional surgery, and cost) and to identify differences in return to work/activity following IB and LRTI. To achieve the study's aims, the investigators will randomize 50 patients as they present to the clinics of the 7 Washington University Orthopaedic Hand surgeons to LRTI (control) or IB (experimental). Patients will follow-up at 2 weeks, 4 weeks, 3 months, and 1 year post-operatively. Primary outcomes will be feasibility (randomization rate, follow-up retention rate), and PROMIS scores at 6 weeks and 3 months. Secondary outcomes will be objective clinical outcomes and return to work/activity. Upon completion of the study's aims, the investigators expect to demonstrate that a prospective, randomized trial comparing ligament reconstruction and tendon interposition (LRTI) and internal brace (IB) is feasible, and that patients who undergo IB will have superior short-term patient-reported outcomes to those who undergo LRTI. Furthermore, the study will generate effect size and variability estimates for a definitive, subsequent randomized controlled trial (RCT). Should the objectives for this study be successful, the IB procedure may be readily incorporated into the Hand surgeon's armamentarium as a viable option for the treatment of CMC OA, and the study will provide essential data to support informed, shared decision-making among patients and their physicians.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Internal Brace | Experimental | Patients will undergo Internal Brace procedure for thumb CMC OA. |
|
| LRTI | Active Comparator | Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trapeziectomy with Internal Brace | Procedure | Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Follow-Up Retention Rate | The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate. | 12 months |
| VAS Pain Scores | Visual Analog Scale (VAS) Pain scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain. | 12 months |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | PROMIS Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. A higher score indicates better upper extremity function. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Thumb Range of Motion: Thumb IP Joint Extension | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University & Barnes-Jewish Orthopedic Center in Chesterfield | St Louis | Missouri | 63017 | United States | ||
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Forty-one patients (42 thumbs) agreed to randomization out of a total of 51 patients (52 thumbs) offered participation. One patient had staged bilateral thumb CMC OA surgery one year apart. Ten patients who initially consented to participate subsequently declined; seven decided against randomization and three elected to forego surgery and continue nonsurgical management. A total of 31 patients (32 thumbs) were randomized out of 51 patients (52 thumbs) offered participation.
Patients were prospectively randomized to LRTI or STS over a 2- year period (December 2019 to December 2021). The enrollment period was prolonged because of the coronavirus disease 2019 pandemic. Potential study participants were identified as they presented to the clinics of five hand surgeons at a single academic medical center.
| ID | Title | Description |
|---|---|---|
| FG000 | Internal Brace | Patients will undergo Internal Brace procedure for thumb CMC OA. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| FG001 | LRTI | Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Internal Brace | Patients will undergo Internal Brace procedure for thumb CMC OA. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Postoperative Follow-Up Retention Rate | The investigators will establish feasibility of a definitive trial by determining the proportion of eligible subjects who agree to randomized treatment and determining follow-up retention rate. | Posted | Count of Units | thumbs | 12 months | thumbs | thumbs |
|
One year
Mild complications were defined as having minor clinical impact (eg, scar tenderness or sensory disturbances). Moderate complications were defined as clinically relevant with delay in patient recovery but resolved by 1-year and not severe enough to need revision surgery (eg, superficial infections, mild CRPS type I). Severe complications were those that resulted in revision surgery or impaired hand function at 1-year (eg, deep infections requiring irrigation & debridement, severe CRPS type I).
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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 | Internal Brace | Patients will undergo Internal Brace procedure for thumb CMC OA. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Concern for deep surgical site infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | A participant had osteolysis on x-rays with concern for infection, requiring irrigation & debridement and implant removal 9 months from index surgery. Intraoperative cultures were negative for infection, pathology demonstrated chronic inflammation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Persistent thumb base pain pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One of 15 LRTI participants had a mild complication of persistent pain at the thumb base. |
First, patients randomized to LRTI and STS participated in different postoperative rehab protocols, which may be a confounding factor in interpreting outcomes. Second, it was not possible to blind surgeons or patients to the procedures and rehab protocol, introducing potential bias. Third, the size of this initial RCT was not sufficient to balance confounding variables between groups. Finally, our cohort was underpowered to detect statistically significant differences in outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Charles Goldfarb | Washington University in St. Louis | (314) 362-3768 | goldfarbc@wustl.edu |
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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 9, 2019 | Nov 16, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 19, 2023 | Mar 17, 2025 | ICF_001.pdf |
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|
| Thumb Range of Motion: Thumb IP Joint Flexion |
Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. |
| 12 months |
| Thumb Range of Motion: Thumb MCP Joint Extension | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Thumb Range of Motion: Thumb MCP Joint Flexion | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Thumb Range of Motion: Thumb CMC Joint Radial Abduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Thumb Range of Motion: Thumb CMC Joint Radial Adduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | 12 months |
| Grip Strength | The investigators will record grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative hands. Grip strength will be measured using dynamometer and recorded in pounds (lbs). | 12 months |
| Pinch Strength: Lateral Pinch | The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch." | 12 months |
| Pinch Strength: Three-Point Pinch | The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch." | 12 months |
| Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op were obtained. Thumb metacarpal subsidence was calculated using the trapezial space ratio (TSR) measured on a posteroanterior wrist radiograph. | 12 months |
| Return to Work/Activity | The investigators will track return to work/activity by asking patients at each follow-up visit (1) IF they have returned to their work and baseline activity, and (2) if so, HOW LONG AFTER THEIR SURGERY did they return (ie, 2 weeks, 4 weeks, 6 weeks, 2 mos, 2.5 mos, 3 mos, 4 mos, 5 mos, >6 mos). Return to work and activity will be compared between the two treatment groups. | 12 months |
| Barnes-Jewish Hospital |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Barnes-Jewish Center for Advanced Medicine - South County | St Louis | Missouri | 63129 | United States |
| BG001 | LRTI | Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
| BG002 | Total | Total of all reporting groups |
| thumbs |
|
| years |
| thumbs |
|
| Sex: Female, Male | Count of Units | thumbs | thumbs |
|
| Race/Ethnicity, Customized | Count of Units | thumbs | thumbs |
|
| Region of Enrollment | Number | thumbs | thumbs |
|
| Current smoker | Count of Units | thumbs | thumbs |
|
| Diabetes | Count of Units | thumbs | thumbs |
|
| Prior ipsilateral hand surgery | Count of Units | thumbs | thumbs |
|
| Prior contralateral hand surgery | Count of Units | thumbs | thumbs |
|
| Preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Score | The PROMIS Anxiety item banks assess self-reported fear, anxious misery, hyperarousal, and somatic symptoms related to arousal. The PROMIS Anxiety Computer Adaptive Test (CAT) was used, in which participant responses guide the system's choice of subsequent items from the full item bank (29 items in total for adults). T-scores were recorded for each participant. A score of 50 is average for the United States general population with a standard deviation of 10. A higher PROMIS T-score represents more anxiety and a worse outcome, with 100 being the highest score. | Mean | Standard Deviation | T-score | Participants |
|
| Pre-op PROMIS Depression Score | The PROMIS Depression item banks assess self-reported negative mood, views of self, and social cognition, as well as decreased positive affect and engagement. The PROMIS Depression Computer Adaptive Test (CAT) was used, in which participant responses guide the system's choice of subsequent items from the full item bank (28 items in total for adults). T-scores were recorded for each participant. A score of 50 is average for the United States general population with a standard deviation of 10. A higher PROMIS depression T-score represents a worse outcome, with 100 being the highest score. | Mean | Standard Deviation | T-score | Participants |
|
| Work status | Count of Participants | Participants | Participants |
|
| LRTI |
Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. |
|
|
| Primary | VAS Pain Scores | Visual Analog Scale (VAS) Pain scores will be collected by a member of our team at all visits. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. Scale ranges from 0 to 10 points. For Pain, 0 indicates no pain and 10 indicates maximum pain. | Posted | Mean | Standard Deviation | score on a scale | 12 months | thumbs | thumbs |
|
|
|
| Primary | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | PROMIS Upper Extremity scores will be collected at all clinic visits on iPad as per standard protocol for all patients presenting to a Washington University Orthopaedic Surgery clinic. These scores will be compared pre-op and at 2 weeks, 4 weeks, 3 months, and 1 year post-op. All PROMIS domain scores are normalized to a mean score of 50 and standard deviation of 10 intending to minimize floor and ceiling effects and ensure the results are readily understood and communicated. A higher score indicates better upper extremity function. | Posted | Mean | Standard Deviation | T-score | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb IP Joint Extension | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb IP Joint Flexion | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb MCP Joint Extension | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb MCP Joint Flexion | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | Thumb ROM at carpometacarpal, metacarpophalangeal, and interphalangeal joints will be collected by a member of our team at baseline, 4 weeks, 3 months, and 1 year after surgery. These values will be reported in degrees and compared between the two groups. | Posted | Mean | Standard Deviation | Degrees | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Grip Strength | The investigators will record grip strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in both the operative hands. Grip strength will be measured using dynamometer and recorded in pounds (lbs). | Posted | Mean | Standard Deviation | Pounds (lbs) | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Pinch Strength: Lateral Pinch | The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch." | Posted | Mean | Standard Deviation | Pounds (lbs) | 12 months | thumbs | thumbs |
|
|
|
| Secondary | Pinch Strength: Three-Point Pinch | The investigators will record pinch strength PRE-OP and POST-OP (all visits except 2 weeks post-op) in the operative hand. Pinch strength will be measured using a pinch gauge and recorded in pounds (lbs). For pinch, the investigators will record "lateral/key pinch" AND "3-point pinch." | Posted | Mean | Standard Deviation | Pounds (lbs) | 12 months | thumbs | thumbs |
|
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| Secondary | Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | Posteroanterior wrist and Roberts view C-arm XRs from pre-op, 3 months post-op, and 1 year post-op were obtained. Thumb metacarpal subsidence was calculated using the trapezial space ratio (TSR) measured on a posteroanterior wrist radiograph. | Posted | Mean | Standard Deviation | Percent reduction of TSR | 12 months | thumbs | thumbs |
|
|
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| Secondary | Return to Work/Activity | The investigators will track return to work/activity by asking patients at each follow-up visit (1) IF they have returned to their work and baseline activity, and (2) if so, HOW LONG AFTER THEIR SURGERY did they return (ie, 2 weeks, 4 weeks, 6 weeks, 2 mos, 2.5 mos, 3 mos, 4 mos, 5 mos, >6 mos). Return to work and activity will be compared between the two treatment groups. | Posted | Count of Units | thumbs | 12 months | thumbs | thumbs |
|
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| 0 |
| 17 |
| 1 |
| 17 |
| 4 |
| 17 |
| EG001 | LRTI | Patients will undergo ligament reconstruction tendon interposition (most commonly performed surgery for thumb CMC OA) and serve as control group. Trapeziectomy with Internal Brace: Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed. | 0 | 15 | 0 | 15 | 1 | 15 |
|
|
| Painless first metacarpal osteolysis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant had painless first metacarpal base osteolysis. |
|
| Hypersensitivity of thumb | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant had hypersensitivity of the thumb that resolved with gabapentin. |
|
| Superficial skin infection | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant had a superficial skin infection that required oral antibiotics. |
|
| Fall with wrist injury | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | One participant sustained a fall 2 weeks after surgery resulting in a partial flexor carpi radials tendon injury in the surgical extremity. |
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