Thumb Carpometacarpal Osteoarthritis
Conditions
Brief summary
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.
Interventions
PROCEDURETrapeziectomy 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.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>50 * Isolated treatment of CMC arthritis * No carpal tunnel syndrome (to avoid outcome data confusion)
Exclusion criteria
* Patients with thumb metacarpophalangeal hyperextension being addressed surgically * Patients with concurrent rheumatoid arthritis/inflammatory arthritis * Patients with history of chronic opioid use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Follow-Up Retention Rate | 12 months | 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. |
| VAS Pain Scores | 12 months | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Thumb Range of Motion: Thumb MCP Joint Flexion | 12 months | 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. |
| Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 12 months | 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. |
| Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 12 months | 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. |
| Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 12 months | 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. |
| Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 12 months | 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. |
| Thumb Range of Motion: Thumb IP Joint Extension | 12 months | 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. |
| Pinch Strength: Lateral Pinch | 12 months | 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. |
| Pinch Strength: Three-Point Pinch | 12 months | 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. |
| Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | 12 months | 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. |
| Return to Work/Activity | 12 months | 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. |
| Grip Strength | 12 months | 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). |
| Thumb Range of Motion: Thumb IP Joint Flexion | 12 months | 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. |
| Thumb Range of Motion: Thumb MCP Joint Extension | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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. | 17 |
| 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. | 15 |
| 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. | 15 |
| Total | 63 |
Baseline characteristics
| Characteristic | Internal Brace | LRTI | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 8 | 61 years STANDARD_DEVIATION 8 | 62 years STANDARD_DEVIATION 8 |
| Current smoker No | 16 thumbs | 13 thumbs | 29 thumbs |
| Current smoker Yes | 1 thumbs | 2 thumbs | 3 thumbs |
| Diabetes No | 14 thumbs | 13 thumbs | 27 thumbs |
| Diabetes Yes | 3 thumbs | 2 thumbs | 5 thumbs |
| Preoperative Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Score | 48 T-score STANDARD_DEVIATION 9 | 51 T-score STANDARD_DEVIATION 10 | 49 T-score STANDARD_DEVIATION 9 |
| Pre-op PROMIS Depression Score | 47 T-score STANDARD_DEVIATION 8 | 46 T-score STANDARD_DEVIATION 10 | 46 T-score STANDARD_DEVIATION 9 |
| Prior contralateral hand surgery No | 13 thumbs | 10 thumbs | 23 thumbs |
| Prior contralateral hand surgery Yes | 4 thumbs | 5 thumbs | 9 thumbs |
| Prior ipsilateral hand surgery No | 13 thumbs | 7 thumbs | 20 thumbs |
| Prior ipsilateral hand surgery Yes | 4 thumbs | 8 thumbs | 12 thumbs |
| Race/Ethnicity, Customized Race Black | 0 thumbs | 2 thumbs | 2 thumbs |
| Race/Ethnicity, Customized Race Other | 1 thumbs | 0 thumbs | 1 thumbs |
| Race/Ethnicity, Customized Race White | 16 thumbs | 13 thumbs | 29 thumbs |
| Region of Enrollment United States | 17 thumbs | 15 thumbs | 32 thumbs |
| Sex: Female, Male Female | 12 thumbs | 12 thumbs | 24 thumbs |
| Sex: Female, Male Male | 5 thumbs | 3 thumbs | 8 thumbs |
| Work status Retired | 5 Participants | 9 Participants | 14 Participants |
| Work status Working | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 4 / 17 | 1 / 15 |
| serious Total, serious adverse events | 1 / 17 | 0 / 15 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 2 week | 27.0 T-score | Standard Deviation 4.6 |
| Internal Brace | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 3 month | 38.6 T-score | Standard Deviation 7.3 |
| Internal Brace | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 4 week | 31.7 T-score | Standard Deviation 5.6 |
| Internal Brace | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 1 year | 41.5 T-score | Standard Deviation 9.8 |
| Internal Brace | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | Pre-op | 32.7 T-score | Standard Deviation 4.8 |
| LRTI | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 1 year | 46.7 T-score | Standard Deviation 6.6 |
| LRTI | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | Pre-op | 36.0 T-score | Standard Deviation 8 |
| LRTI | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 2 week | 29.6 T-score | Standard Deviation 6.9 |
| LRTI | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 4 week | 35.6 T-score | Standard Deviation 7.1 |
| LRTI | Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Scores | 3 month | 42.7 T-score | Standard Deviation 7.8 |
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.
Time frame: 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Internal Brace | Postoperative Follow-Up Retention Rate | 3-month follow-up | Yes | 17 thumbs |
| Internal Brace | Postoperative Follow-Up Retention Rate | 3-month follow-up | No | 0 thumbs |
| Internal Brace | Postoperative Follow-Up Retention Rate | 1-year follow-up | Yes | 17 thumbs |
| Internal Brace | Postoperative Follow-Up Retention Rate | 1-year follow-up | No | 0 thumbs |
| LRTI | Postoperative Follow-Up Retention Rate | 1-year follow-up | No | 1 thumbs |
| LRTI | Postoperative Follow-Up Retention Rate | 3-month follow-up | Yes | 13 thumbs |
| LRTI | Postoperative Follow-Up Retention Rate | 1-year follow-up | Yes | 14 thumbs |
| LRTI | Postoperative Follow-Up Retention Rate | 3-month follow-up | No | 2 thumbs |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | VAS Pain Scores | Pre-op | 7.4 score on a scale | Standard Deviation 1.3 |
| Internal Brace | VAS Pain Scores | 3 month | 2.5 score on a scale | Standard Deviation 2.3 |
| Internal Brace | VAS Pain Scores | 2 week | 3.9 score on a scale | Standard Deviation 2.3 |
| Internal Brace | VAS Pain Scores | 1 year | 2.4 score on a scale | Standard Deviation 2.5 |
| Internal Brace | VAS Pain Scores | 4 week | 3.1 score on a scale | Standard Deviation 2.3 |
| LRTI | VAS Pain Scores | 1 year | 2.4 score on a scale | Standard Deviation 2.9 |
| LRTI | VAS Pain Scores | Pre-op | 7.7 score on a scale | Standard Deviation 1.7 |
| LRTI | VAS Pain Scores | 4 week | 1.8 score on a scale | Standard Deviation 1.2 |
| LRTI | VAS Pain Scores | 3 month | 1.6 score on a scale | Standard Deviation 1.1 |
| LRTI | VAS Pain Scores | 2 week | 2.9 score on a scale | Standard Deviation 2.1 |
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).
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Grip Strength | Pre-op | 37 Pounds (lbs) | Standard Deviation 17 |
| Internal Brace | Grip Strength | 4 week | 26 Pounds (lbs) | Standard Deviation 11 |
| Internal Brace | Grip Strength | 3 month | 41 Pounds (lbs) | Standard Deviation 16 |
| Internal Brace | Grip Strength | 1 year | 56 Pounds (lbs) | Standard Deviation 17 |
| LRTI | Grip Strength | 1 year | 63 Pounds (lbs) | Standard Deviation 20 |
| LRTI | Grip Strength | Pre-op | 48 Pounds (lbs) | Standard Deviation 29 |
| LRTI | Grip Strength | 3 month | 46 Pounds (lbs) | Standard Deviation 24 |
| LRTI | Grip Strength | 4 week | 22 Pounds (lbs) | Standard Deviation 21 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Pinch Strength: Lateral Pinch | Pre-op | 9 Pounds (lbs) | Standard Deviation 4 |
| Internal Brace | Pinch Strength: Lateral Pinch | 4 week | 5 Pounds (lbs) | Standard Deviation 3 |
| Internal Brace | Pinch Strength: Lateral Pinch | 3 month | 9 Pounds (lbs) | Standard Deviation 3 |
| Internal Brace | Pinch Strength: Lateral Pinch | 1 year | 13 Pounds (lbs) | Standard Deviation 4 |
| LRTI | Pinch Strength: Lateral Pinch | 1 year | 13 Pounds (lbs) | Standard Deviation 5 |
| LRTI | Pinch Strength: Lateral Pinch | Pre-op | 11 Pounds (lbs) | Standard Deviation 6 |
| LRTI | Pinch Strength: Lateral Pinch | 3 month | 10 Pounds (lbs) | Standard Deviation 5 |
| LRTI | Pinch Strength: Lateral Pinch | 4 week | 3 Pounds (lbs) | Standard Deviation 3 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Pinch Strength: Three-Point Pinch | Pre-op | 8 Pounds (lbs) | Standard Deviation 6 |
| Internal Brace | Pinch Strength: Three-Point Pinch | 4 week | 4 Pounds (lbs) | Standard Deviation 2 |
| Internal Brace | Pinch Strength: Three-Point Pinch | 3 month | 7 Pounds (lbs) | Standard Deviation 3 |
| Internal Brace | Pinch Strength: Three-Point Pinch | 1 year | 11 Pounds (lbs) | Standard Deviation 3 |
| LRTI | Pinch Strength: Three-Point Pinch | 1 year | 12 Pounds (lbs) | Standard Deviation 4 |
| LRTI | Pinch Strength: Three-Point Pinch | Pre-op | 9 Pounds (lbs) | Standard Deviation 4 |
| LRTI | Pinch Strength: Three-Point Pinch | 3 month | 11 Pounds (lbs) | Standard Deviation 6 |
| LRTI | Pinch Strength: Three-Point Pinch | 4 week | 2 Pounds (lbs) | Standard Deviation 3 |
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.
Time frame: 12 months
| Arm | Measure | Group | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|---|
| Internal Brace | Return to Work/Activity | 2 week | Yes | 4 thumbs |
| Internal Brace | Return to Work/Activity | 2 week | No | 13 thumbs |
| Internal Brace | Return to Work/Activity | 4 week | Yes | 8 thumbs |
| Internal Brace | Return to Work/Activity | 4 week | No | 9 thumbs |
| Internal Brace | Return to Work/Activity | 3 month | Yes | 13 thumbs |
| Internal Brace | Return to Work/Activity | 3 month | No | 4 thumbs |
| Internal Brace | Return to Work/Activity | 1 year | Yes | 17 thumbs |
| Internal Brace | Return to Work/Activity | 1 year | No | 0 thumbs |
| LRTI | Return to Work/Activity | 1 year | No | 0 thumbs |
| LRTI | Return to Work/Activity | 2 week | Yes | 7 thumbs |
| LRTI | Return to Work/Activity | 3 month | Yes | 14 thumbs |
| LRTI | Return to Work/Activity | 2 week | No | 8 thumbs |
| LRTI | Return to Work/Activity | 1 year | Yes | 15 thumbs |
| LRTI | Return to Work/Activity | 4 week | Yes | 9 thumbs |
| LRTI | Return to Work/Activity | 3 month | No | 1 thumbs |
| LRTI | Return to Work/Activity | 4 week | No | 6 thumbs |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | 3 months | 48 Percent reduction of TSR | Standard Deviation 22.4 |
| Internal Brace | Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | 1 year | 55 Percent reduction of TSR | Standard Deviation 18.4 |
| LRTI | Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | 3 months | 42 Percent reduction of TSR | Standard Deviation 13.6 |
| LRTI | Thumb Metacarpal Radiographic Subsidence: Trapezial Space Ratio Reduction | 1 year | 46 Percent reduction of TSR | Standard Deviation 12.2 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | Pre-op | 47 Degrees | Standard Deviation 6 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 4 week | 47 Degrees | Standard Deviation 4 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 3 month | 48 Degrees | Standard Deviation 8 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 1 year | 47 Degrees | Standard Deviation 6 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 1 year | 50 Degrees | Standard Deviation 5 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | Pre-op | 40 Degrees | Standard Deviation 11 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 3 month | 49 Degrees | Standard Deviation 6 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Abduction | 4 week | 45 Degrees | Standard Deviation 6 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | Pre-op | 16 Degrees | Standard Deviation 10 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 4 week | 23 Degrees | Standard Deviation 7 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 3 month | 16 Degrees | Standard Deviation 9 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 1 year | 19 Degrees | Standard Deviation 6 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 1 year | 21 Degrees | Standard Deviation 4 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | Pre-op | 23 Degrees | Standard Deviation 4 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 3 month | 21 Degrees | Standard Deviation 4 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Palmar Adduction | 4 week | 27 Degrees | Standard Deviation 5 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | Pre-op | 45 Degrees | Standard Deviation 6 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 4 week | 45 Degrees | Standard Deviation 7 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 3 month | 49 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 1 year | 45 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 1 year | 49 Degrees | Standard Deviation 7 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | Pre-op | 42 Degrees | Standard Deviation 11 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 3 month | 42 Degrees | Standard Deviation 9 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Abduction | 4 week | 39 Degrees | Standard Deviation 6 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | Pre-op | 15 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 4 week | 23 Degrees | Standard Deviation 8 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 3 month | 15 Degrees | Standard Deviation 9 |
| Internal Brace | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 1 year | 18 Degrees | Standard Deviation 8 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 1 year | 18 Degrees | Standard Deviation 9 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | Pre-op | 17 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 3 month | 17 Degrees | Standard Deviation 9 |
| LRTI | Thumb Range of Motion: Thumb CMC Joint Radial Adduction | 4 week | 21 Degrees | Standard Deviation 9 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Extension | Pre-op | 18 Degrees | Standard Deviation 12 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Extension | 4 week | 13 Degrees | Standard Deviation 12 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Extension | 3 month | 11 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Extension | 1 year | 17 Degrees | Standard Deviation 14 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Extension | 1 year | 20 Degrees | Standard Deviation 14 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Extension | Pre-op | 19 Degrees | Standard Deviation 9 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Extension | 3 month | 21 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Extension | 4 week | 11 Degrees | Standard Deviation 10 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Flexion | Pre-op | 49 Degrees | Standard Deviation 14 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Flexion | 4 week | 41 Degrees | Standard Deviation 14 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Flexion | 3 month | 51 Degrees | Standard Deviation 12 |
| Internal Brace | Thumb Range of Motion: Thumb IP Joint Flexion | 1 year | 52 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Flexion | 1 year | 56 Degrees | Standard Deviation 13 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Flexion | Pre-op | 44 Degrees | Standard Deviation 17 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Flexion | 3 month | 50 Degrees | Standard Deviation 12 |
| LRTI | Thumb Range of Motion: Thumb IP Joint Flexion | 4 week | 32 Degrees | Standard Deviation 20 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Extension | Pre-op | 9 Degrees | Standard Deviation 10 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Extension | 4 week | 7 Degrees | Standard Deviation 8 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Extension | 3 month | 9 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Extension | 1 year | 8 Degrees | Standard Deviation 7 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Extension | 1 year | 10 Degrees | Standard Deviation 12 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Extension | Pre-op | 14 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Extension | 3 month | 7 Degrees | Standard Deviation 8 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Extension | 4 week | 5 Degrees | Standard Deviation 6 |
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Flexion | Pre-op | 44 Degrees | Standard Deviation 12 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Flexion | 4 week | 29 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Flexion | 3 month | 32 Degrees | Standard Deviation 11 |
| Internal Brace | Thumb Range of Motion: Thumb MCP Joint Flexion | 1 year | 35 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Flexion | 1 year | 47 Degrees | Standard Deviation 9 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Flexion | Pre-op | 48 Degrees | Standard Deviation 10 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Flexion | 3 month | 39 Degrees | Standard Deviation 8 |
| LRTI | Thumb Range of Motion: Thumb MCP Joint Flexion | 4 week | 22 Degrees | Standard Deviation 11 |