| Literature DB >> 35284582 |
Yining Lu1, Avinesh Agarwalla2, Ophelie Lavoie-Gagne3, Bhavik H Patel4, Alexander Beletsky5, Benedict U Nwachukwu6, Nikhil N Verma7, Brian J Cole7, Brian Forsythe7.
Abstract
Background: Clinically significant outcomes (CSOs) connect patient-reported outcome measures data to patient-perceived benefit. Although investigators have established threshold values for various CSOs, the timeline to achieve these outcomes after isolated biceps tenodesis (BT) has yet to be defined. Purpose: To define the time-dependent nature of minimal clinically important difference (MCID), substantial clinical benefit (SCB), and Patient Acceptable Symptom State (PASS) achievement after isolated BT. Study Design: Case series; Level of evidence, 4.Entities:
Keywords: ASES; biceps tenodesis; clinically significant outcomes; minimum clinically important difference; timeline
Year: 2022 PMID: 35284582 PMCID: PMC8908395 DOI: 10.1177/23259671221070857
Source DB: PubMed Journal: Orthop J Sports Med ISSN: 2325-9671
Demographic and Clinical Characteristics of the Study Population (N = 190)
| Characteristic | Value |
|---|---|
| Age, y, mean ± SD | 46.9 ± 13.01 |
| Male sex, n (%) | 121 (64) |
| Worker compensation, n (%) | 54 (28) |
| BMI, kg/m2, mean ± SD | 28.71 ± 5.95 |
| Positive smoking history, n (%) | 46 (24) |
| Current smoker, n | 26 |
| Former smoker, n | 20 |
| Diabetes, n (%) | 12 (6.3) |
| Hypertension, n (%) | 31 (16.4) |
| Thyroid, n (%) | 12 (6.3) |
| Preoperative diagnosis, n | |
| Rotator cuff tendinopathy | 56 |
| Biceps-labral complex | 112 |
| Miscellaneous | 24 |
| Bicep pathology on arthroscopy, n (%) | |
| No gross pathology | 18 (9.4) |
| Complete tear | 13 (6.8) |
| Partial tear | 16 (8.4) |
| Tenosynovitis | 143 (75.3) |
| Tenodesis technique, n (%) | |
| Arthroscopic suprapectoral | 47 (22.1) |
| Open subpectoral | 143 (77.9) |
| Fixation device, n (%) | |
| Tenodesis screw | 57 (30.0) |
| Suture anchor | 133 (70.0) |
BMI, body mass index.
Subacromial impingement, acromioclavicular arthropathy, or capsulitis.
Mean Patient-Reported Outcome Scores at Baseline and Follow-up Time Points
| PROM | Baseline | 6 Months | 12 Months |
|
|---|---|---|---|---|
| ASES | 47.4 ± 19.0 | 70.7 ± 20.9 | 72.3 ± 23.7 | <.01 |
| SANE | 33.4 ± 22.5 | 64.4 ± 25.4 | 65.9 ± 29.7 | <.01 |
| CMS | 12.5 ± 6.9 | 20.3 ± 8.7 | 21.3 ± 9.7 | <.01 |
ASES, American Shoulder and Elbow Surgeons score; CMS, Constant-Murley score; PROM, patient-reported outcome measure; SANE, Single Assessment Numeric Evaluation.
value at α = .01 for 1-way analysis of variance across baseline and postoperative time points.
Cumulative Probability of Achieving CSOs at Follow-up
| 6 Months | 12 Months | |||||
|---|---|---|---|---|---|---|
| PROM | MCID, % | SCB, % | PASS, % | MCID, % | SCB, % | PASS, % |
| ASES | 71.3 | 59.4 | 69.5 | 77.8 | 64.1 | 70.8 |
| SANE | 83.1 | 80 | 61.2 | 83.2 | 80.2 | 62.9 |
| CMS | 76.4 | 35.9 | 58.3 | 78.7 | 42.2 | 59.7 |
ASES, American Shoulder and Elbow Surgeons Score; CMS, Constant-Murley score; CSO, Clinically Significant Outcome; MCID, minimal clinically important difference; PASS, Patient Acceptable Symptom State; PROM, patient-reported outcome measure; SANE, Single Assessment Numeric Evaluation; SCB, substantial clinical benefit.
Figure 1.Cumulative probability for achieving MCID, SCB, and PASS on (A) ASES, (B) SANE, and (C) CMS. ASES, American Shoulder and Elbow Surgeons score; CMS, Constant-Murley score; MCID, minimal clinically important difference; PASS, Patient Acceptable Symptom State; SANE, Single Assessment Numeric Evaluation; SCB, substantial clinical benefit. Dashed lines indicate median time to achievement of MCID, SCB, or PASS.
Characteristics Predictive of Time to Achieve MCID
| HR (95% CI) for Time to Achieve MCID | |||
|---|---|---|---|
| ASES | SANE | CMS | |
| Single-year age increase | NS | 1.01 (1.00-1.02) | 1.01 (1.00-1.03) |
| Male sex | NS | 0.41 (0.32-0.61) | NS |
| BMI | 1.03 (1.0-1.1) | 1.01 (1.01-1.02) | NS |
| Preoperative thyroid disease |
|
|
|
| Smoking history, former smoker | NS |
| NS |
| Smoking history, current smoker | NS | 3.82 (1.95-7.45) | NS |
| Tendon tear on arthroscopy | 1.81 (1.21-2.73) | 2.21 (1.41-3.46) | NS |
| Absence of gross tendon pathology on arthroscopy | NS | 0.19 (0.04-0.96) |
|
| Arthroscopic suprapectoral tenodesis | NS | NS | 1.66 (1.1-2.5) |
| Preoperative ASES | NS | 1.03 (1.02-1.04) | 1.04 (1.02-1.1) |
| Preoperative SANE | NS | 1.02 (1.01-1.03) | NS |
| Preoperative CMS | NS | 1.12 (1.08-1.2) | 0.97 (0.95-0.99) |
Bolded values denote variables that maintained significance after multivariate Weibull parametric regression. The following variables were found to be nonsignificant predictors on univariate testing: worker compensation status, diabetes, hypertension, bicep tenosynovitis on arthroscopy, arthroscopic versus open tenodesis, and type of fixation device. ASES, American Shoulder and Elbow Surgeons score; BMI, body mass index; CMS, Constant-Murley score; HR, hazard ratio; MCID, minimal clinically important difference; NS, nonsignificant; SANE, Single Assessment Numeric Evaluation.
Characteristics Predictive of Time to Achieve SCB
| HR (95% CI) for Time to Achieve MCID | |||
|---|---|---|---|
| ASES | SANE | CMS | |
| Older age | NS | NS |
|
| Male sex | NS | 0.42 (0.29-0.62) |
|
| BMI |
|
|
|
| Smoking history, current smoker | NS | 1.65 (1.21-2.26) | NS |
| Preoperative thyroid disease | NS | 1.91 (1.32-3.04) | NS |
| Tendon tear on arthroscopy | 1.71 (1.14-2.62) | 2.18 (1.42-3.42) | 1.65 (1.14-2.37) |
| Absence of gross tendon pathology on arthroscopy | NS |
|
|
| Preoperative ASES | NS | 1.03 (1.02-1.04) | NS |
Bolded values denote variables that maintained significance after multivariate Weibull parametric regression. The following variables were found to be insignificant predictors on univariate testing: worker compensation status, being a former smoker, diabetes, hypertension, bicep tenosynovitis on arthroscopy, arthroscopic versus open tenodesis, type of fixation device, and preoperative SANE and CMS scores. ASES, American Shoulder and Elbow Surgeons score; BMI, body mass index; CMS, Constant-Murley score; HR, hazard ratio; MCID, minimal clinically important difference; NS, nonsignificant; SANE, Single Assessment Numeric Evaluation; SCB, substantial clinical benefit.
Characteristics Predictive of Time to Achieve PASS
| HR (95% CI) for Time to Achieve MCID | |||
|---|---|---|---|
| ASES | SANE | CMS | |
| Male sex | 1.92 (1.31-2.81) | NS |
|
| Preoperative thyroid disease |
|
|
|
| BMI |
| NS | NS |
| Worker compensation status | 0.05 (0.01-0.36) | NS | NS |
| Smoking history, former smoker | NS |
| NS |
| Smoking history, current smoker | NS |
| NS |
| Diabetes | NS | 0.15 (0.04-0.57) | NS |
| Tendon tear on arthroscopy | 2.27 (1.61-3.28) | NS | NS |
| Absence of gross tendon pathology on arthroscopy | 0.27 (0.05-0.95) | 0.33 (0.14-0.75) | NS |
| Preoperative ASES | 1.02 (1.01-1.04) | 1.02 (1.01-1.03) | 1.01 (0.99-1.02) |
| Preoperative CMS | 1.09 (1.07-1.15) | 1.08 (1.05-1.12) |
|
Bolded values denote variables that maintained significance after multivariate Weibull parametric regression. The following variables were found to be insignificant predictors on univariate testing: age, hypertension, bicep tenosynovitis on arthroscopy, arthroscopic versus open tenodesis, type of fixation device, and preoperative SANE scores. ASES, American Shoulder and Elbow Surgeons score; BMI, body mass index; CMS, Constant-Murley score; HR, hazard ratio; MCID, minimal clinically important difference; NS, nonsignificant; PASS, Patient Acceptable Symptom State; SANE, Single Assessment Numeric Evaluation.