Abstract
Introduction
There is limited medium-term outcome data regarding the predictors of functional outcome and patient satisfaction after arthroscopic rotator cuff repair.
Methods
287 patients that underwent arthroscopic rotator cuff repair under a high-volume single surgeon were contacted at a minimum of 4 years following surgery. Patient demographics, tear size and co-morbidities were pre-operatively recorded. The Oxford shoulder score, EuroQol 5-dimensional score and patient satisfaction were recorded at final follow-up.
Results
234 (81.5%) patients completed follow-up at a mean of 5.5 (4–9) years. There were 126 males and 108 females with a mean age of 60 (range 25–83) years. The majority of patients (n = 211, 90%) were satisfied with their final outcome. Multivariate linear regression analysis (R2 = 0.64) identified that increasing tear size (p = 0.04), worsening general health assessed by the EuroQol 5-Dimensional (p < 0.001), and smoking (p = 0.049) were associated with a worse Oxford shoulder score. Logistic regression analysis (R2 = 0.13) identified that worsening general health assessed by the EuroQol 5-Dimensional (p < 0.001), and smoking (p = 0.01) were associated with an increased risk of patient dissatisfaction.
Conclusion
General health status and smoking are independent predictors of functional outcome and patient satisfaction at medium-term follow-up following arthroscopic rotator cuff repair.
Keywords: Rotator cuff repair, long-term outcome
Introduction
Surgical repair of a torn rotator cuff is thought to provide pain relief, functional improvement and a high level of patient satisfaction.1,2 The results of open, mini-open and arthroscopic rotator cuff repair are thought to be generally comparable. 3 The intervention has been shown to be cost effective regardless of age at time of surgery in appropriately selected patients. 4 Despite the variable re-rupture rate following surgery that is reported in the literature, patients are still thought to have significant improvements in pain and function compared to their pre-operative morbidity.5–8
The success of arthroscopic rotator cuff repair is complex and multi-factoral. Great importance is often placed on technical aspects of the operation 9 and rehabilitation 10 which are believed to directly impact patient outcome. The presence of specific patient characteristics has also been associated with inferior functional outcome scores and can be thought of as modifiable (e.g. smoking) or non-modifiable (increasing age, tear size and worker compensation).11–13 Clinically relevant prognostic factors that influence a patient's medium-term functional outcome and overall satisfaction following rotator cuff repair remain poorly understood from the current literature. A greater understanding of these would potentially enable better patient selection and could assist patients when deciding on surgical intervention.
The primary aim was to identify independent predictors of functional outcome, according to the Oxford shoulder score (OSS), and patient satisfaction after arthroscopic rotator cuff repair in the medium term. The secondary aim was to assess whether the post-operative OSS was related to patient satisfaction at final follow-up.
Patients and methods
Patients for this study were identified retrospectively from a prospectively compiled database held at the study centre. Eligible patients were those who underwent a primary arthroscopic rotator cuff repair at a minimum of four post-operatively. Patients were excluded if there was a history of prior shoulder dislocation or fracture, acromioclavicular pathology, degenerative or inflammatory arthrosis, infection, neuropathic changes, prior surgical procedures to the shoulder and those where repair could not be achieved intra-operatively.
All patients were initially managed with non-operative treatment for a minimum of six months, including non-steroidal anti-inflammatory medication and formal physiotherapy rehabilitation. In all cases, the decision to proceed with rotator cuff repair was based on the history, physical examination, degree of functional debilitation, documentation of a tear using either magnetic resonance imaging or ultrasound, and failure of non-operative treatment. During the 7-year period, 287 patients underwent arthroscopic rotator cuff repair and met the inclusion criteria for the study. All patients were operated on by the senior author who is a high-volume arthroscopic shoulder surgeon.
Operative technique and rehabilitation
A standardised treatment protocol was used. All patients were managed on a day case basis and surgery was performed under a general anaesthetic with an interscalene block. The beach chair position was used for all patients and an arthroscopic rotator cuff repair was performed using an average of four to six portals depending on the need for access. A subacromial decompression using a cutting block technique (Caspari) was performed before the rotator cuff repair in all cases. 14 Any patient requiring distal clavicle resection was excluded from this investigation. Intra-operative measurement of tear size was performed according to the system of DeOrio and Cofield. 15 The rotator cuff repair was performed by the senior author using a standard, double row technique as described by Lo and Burkhart. 16 Double-loaded bio-absorbable suture anchors were used to repair the tear. Either one or two anchors were inserted at the junction between the articular cartilage and the medial footprint of the greater tuberosity junction. Deep mattress sutures were passed through the tendon, one or two lateral anchors were then inserted and joined as simple or looped sutures to invert the lateral edge of the tear. In U or V-shaped tears, side-to-side sutures were used to close the medial extent of the tear and a double row of anchors were used to secure it to the greater tuberosity.
Gentle pendular exercises were initiated on the first postoperative day. The patients remained in a poly-sling for 4 weeks, after which they commenced a formal physiotherapy programme. This consisted of passive and active-assisted movement leading up to active range at 8–10 weeks, followed by strengthening exercises from 3 months. All patients were reviewed at 3 months and discharged from further follow-up at the 1-year review if there was no on-going concern.
Outcome measures
All patients were asked to complete a postal questionnaire relating to their outcome. Patient demographics and comorbidities were recorded at time of initial operation by the treating surgeon. Categories of comorbidity included: heart disease, lung disease, vascular disease, neurological problems, stomach ulcer, kidney disease, liver disease, and back pain, which were recorded as dichotomous variables. Current smoking status was self-reported by the patient.
The OSS consists of 12 questions assessed on a Likert scale with values from 0 to 4; a summative score is then calculated where 48 is the best possible score (least symptomatic) and 0 is the worst possible score (most symptomatic). 17 The EuroQol 5-dimension (EQ-5D) questionnaire was used, with the responses recorded at three levels of severity (no problems, some problems or extreme problems). 18 Pain was also assessed using the standard vertical 20 cm visual analogue scale (EQ-5D VAS) which is transformed to a scale of 0–100 with current health-related quality of life. An individual patient's health state can be reported based on the five-digit code for each domain (i.e. 11,212). There are 243 possible health states. Patient satisfaction was assessed by asking the question ‘How satisfied are you with your operated shoulder?’ using a postal questionnaire. The response was recorded using a four-point Likert scale: very satisfied, satisfied, neither satisfied or dissatisfied, dissatisfied or very dissatisfied. Patients who recorded very satisfied or satisfied were classified as satisfied.
The size of rotator cuff tear was obtained retrospectively from the operation note and classed as: small (< 1 cm), medium (1–3 cm), large (3–5 cm) and massive (> 5 cm). 15
Statistical analysis and ethical considerations
Statistical analysis was performed using Statistical Package for Social Sciences version 17.0 (SPSS Inc., Chicago, IL, USA). Parametric and non-parametric tests were used as appropriate to assess continuous variables for significant differences between groups. A Student's t-test, unpaired and paired, or analysis of variance (ANOVA) were used to compare linear variables between groups, and Pearson's correlation was used to assess the relationship between linear variables. Dichotomous variables were assessed using a Chi-square test Multivariate linear and bivariate regression analyses were used to identify independent predictors of outcome (post-operative OSS and patient satisfaction, respectively). Receiver operating characteristic (ROC) curve analysis was used to identify thresholds in the OSS that identified patient satisfaction. The area under the ROC curve ranges from 0.5, which indicates a test with no accuracy in distinguishing whether a patient is satisfied, to 1.0 where the test is perfectly accurate identifying all satisfied patients. The threshold is equivalent to the point (OSS) at which the sensitivity and specificity are maximal in predicting patient satisfaction. A p-value of < 0.05 was considered significant.
Ethical approval was obtained from the regional ethics committee for collection, analysis, and publication of the data contained within the study. All patients gave their written consent to participate in this research.
Results
The study cohort consisted of 234 patients of which 126 were male and 108 were female with a mean age of 60 (range 25–83) years. The overall response rate was 81.5% (n = 234/287). There were no significant differences for gender (p = 0.18 Chi-square), age (mean difference 5.2 years, p = 0.23 t-test) or cuff tear size (p = 0.70 Chi-square) in the 53 patients that were excluded from the analysis. The mean follow-up time from index surgery was 5.4 (range 4–9) years. No patient underwent revision surgery for recurrent cuff tear at time of follow-up.
The most prevalent comorbidities were back pain and diabetes (Table 1). One in ten patients declared they were current smokers, and the most prevalent size of cuff tear was medium (Table 1). The mean EQ-5D at last follow-up was 0.718 (standard deviation (SD) 0.319), and the mean pain score was 69 (SD 30).
Table 1.
Patient demographics, comorbidity, smoking status and size of cuff tear for the study cohort.
| Demographic | Descriptive | Study cohort (n = 234) |
|---|---|---|
| Gender (M/F) (n, % of group) | Male | 126 (53.8) |
| Female | 108 (46.2) | |
| Mean age (years: mean, SD) | 60 (10.5) | |
| Comorbidity (n, % of group) | Heart disease | 9 (3.8) |
| Lung disease | 18 (7.7) | |
| Vascular disease | 3 (1.3) | |
| Neurological disease | 5 (2.1) | |
| Diabetes mellitus | 25 (10.7) | |
| Gastric ulceration | 2 (0.9) | |
| Kidney disease | 1 (0.4) | |
| Liver disease | 4 (1.7) | |
| Back pain | 96 (41.0) | |
| Smoker (n, % of group) | Yes | 27 (11.5) |
| No | 207 (88.5) | |
| Tear size | Small | 37 (15.8) |
| Medium | 89 (38.0) | |
| Large | 49 (20.9) | |
| Massive | 59 (25.2) | |
The mean OSS was 38.7 (SD 10.6). Factors significantly influencing the OSS on univariate and bivariate analysis included comorbidities of lung disease, neurological disease and back pain, EQ-5D and associated pain (Table 2). There was a trend towards significance for smoking status above the minimal clinical difference (OSS 35.4 vs. 39.1, p = 0.09), with smokers having a worse outcome on regression analysis (Table 3).
Table 2.
Predictors of OSS at last follow-up (mean 5.4 years) after arthroscopic rotator cuff repair on univariate analysis.
| Demographic | Descriptive | Mean OSS | Correlation (r) | p-value a |
|---|---|---|---|---|
| Gender (M/F) (mean, SD) | Male | 38.9 (10.7) | – | 0.79 |
| Female | 38.5 (10.4) | – | ||
| Mean Age | – | 0.01 | 0.91 b | |
| Comorbidity (mean, SD) | Heart disease | 39.1 (11.7) | – | 0.68 |
| Lung disease | 31.9 (12.0) | – | < 0.001 | |
| Vascular disease | 31.3 (7.6) | – | 0.16 | |
| Neurological disease | 31.6 (10.2) | – | 0.045 | |
| Diabetes mellitus | 38.5 (10.5) | – | 0.43 | |
| Gastric ulceration | 22.5 (19.1) | – | 0.41 | |
| Kidney disease | 16.0 | – | N/A | |
| Liver disease | 33.5 (13.7) | – | 0.11 | |
| Back pain | 36.2 (11.5) | – | < 0.001 | |
| Smoker (mean, SD) | Yes | 35.4 (13.0) | – | 0.09 |
| No | 39.1 (10.2) | – | ||
| Tear size | Small | 38.9 (11.1) | – | 0.56 c |
| (mean, SD) | Medium | 39.6 (10.2) | – | |
| Large | 38.7 (11.0) | – | ||
| Massive | 37.7 (10.6) | – | ||
| EQ-5D | – | 0.77 | < 0.001 b | |
| Pain score | – | 0.50 | < 0.001 b | |
OSS: Oxford shoulder score; EQ-5D: EuroQol 5-dimensional; ANOVA: analysis of variance.
t-test unless otherwise stated.
Pearson correlation.
ANOVA.
Table 3.
Significant independent predictors of the midterm OSS after using multivariable linear regression analysis. All variables in Table 2 were entered into the model using a ‘enter’ methodology (R2 = 0.64).
| Demographic | Descriptive | B | 95% CI | p-value | |
|---|---|---|---|---|---|
| Lower | Lower | ||||
| Smoker | No | Reference | −0.01 | −5.63 | 0.049 |
| Yes | −2.82 | ||||
| Tear size | Small | Reference | |||
| Medium | −0.95 | −0.31 | −1.92 | 0.043 | |
| Large | −1.90 | −0.62 | −3.84 | 0.02 | |
| Massive | −3.80 | −1.24 | −7.68 | 0.01 | |
| EQ-5D (for each 0.1 change) | 2.64 | 2.33 | 2.96 | < 0.0001 | |
OSS: Oxford shoulder score; EQ-5D: EuroQol 5-dimensional.
Primary aim—predictors of OSS and satisfaction
Multivariate analysis was used to adjust for confounding variables, which demonstrated smoking status, size of cuff tear, and the EQ-5D to be independent predictors of midterm OSS. There was a strong positive correlation between the OSS and EQ-5D (Pearson correlation r = 0.77) (Figure 1). The EQ-5D VAS assessment was removed from the model, due to a variance inflation factor of greater than 2 and a high correlation with the EQ-5D score, that is, measuring a similar effect as the EQ-5D score.
Figure 1.
Correlation between the Oxford shoulder score and the EuroQol 5-dimensional (EQ-5D) (r = 0.77). Dashed lines represent 95% confidence intervals.
The majority of patients defined their outcome as either very satisfied (n = 171) or satisfied (n = 40) (overall satisfaction 90.2%; 211/234). The remainder were neither satisfied or dissatisfied (n = 12), dissatisfied (n = 7) or very dissatisfied (n = 4). Factors significantly influencing satisfaction on univariate analysis included comorbidities of lung disease, kidney disease and liver disease, smoking status, EQ-5D and associated pain (Table 4). Logistic regression analysis identified smoking status and general health according to the EQ-5D as the only independent predictors of satisfaction (Table 5). Size of cuff tear was not significant after adjusting for confounding variables (p > 0.16).
Table 4.
Predictors of satisfaction at last follow-up (mean 5.4 years) after arthroscopic rotator cuff repair on univariate analysis.
| Demographic | Descriptive | Satisfied | p-value a | |
|---|---|---|---|---|
| Yes (n = 211) | No (n = 23) | |||
| Gender (M/F) (n, % of group) | Male | 111 | 15 | 0.25 |
| Female | 100 | 8 | ||
| Mean age (mean, SD) | 60.2 (10.5) | 60.6 (11.6) | 0.86 b | |
| Comorbidity (n, % of group) | Heart disease | 9 | 1 | 0.93 |
| Lung disease | 14 | 4 | 0.02 | |
| Vascular disease | 2 | 1 | 0.11 | |
| Neurological disease | 4 | 1 | 0.41 | |
| Diabetes mellitus | 23 | 2 | 0.83 | |
| Gastric ulceration | 1 | 1 | 0.12 | |
| Kidney disease | 0 | 1 | 0.002 | |
| Liver disease | 2 | 2 | 0.01 | |
| Back pain | 83 | 20 | 0.13 | |
| Smoker (n, % of group) | Yes | 20 | 7 | 0.003 |
| No | 188 | 16 | ||
| Tear size | Small | 32 | 5 | 0.36 |
| (n, % of group) | Medium | 81 | 8 | |
| Large | 42 | 7 | ||
| Massive | 56 | 3 | ||
| EQ-5D (mean, SD) | 0.751 (0.298) | 0.417 (0.350) | < 0.001 b | |
| Pain score (mean, SD) | 71.0 (29.4) | 49.4 (25.5) | 0.001 b | |
OSS: Oxford shoulder score; EQ-5D: EuroQol 5-dimensional.
chi-square test unless otherwise stated.
t-test.
Table 5.
Significant independent predictors of the midterm satisfaction after using logistic regression analysis. All variables in Table 2 were entered into the model using a ‘enter’ methodology (Nagelkerke R2 = 0.27).
| Demographic | Descriptive | OR | 95% CI | p-value | |
|---|---|---|---|---|---|
| Lower | Lower | ||||
| Smoker | Yes | Reference | 1.37 | 13.79 | 0.01 |
| No | 4.34 | ||||
| EuroQol 5-dimensional (EQ-5D; for each 1.0 change) | 18.5 | 5.16 | 66.45 | < 0.0001 | |
Secondary aim—OSS effect on satisfaction
There was a significantly lower (worse) mean OSS with decreasing level of satisfaction (ANOVA p < 0.001) (Table 6).
Table 6.
Significant mean OSS according to level of patient satisfaction and p-values (ANOVA with Bonferroni correction) for differences between groups.
| Level of satisfaction | OSS (mean, SD) | Level of satisfaction | ||||
|---|---|---|---|---|---|---|
| Very satisfied | Satisfied | Neither | Dissatisfied | Very dissatisfied | ||
| Very satisfied | 42 (8.1) | – | – | – | – | – |
| Satisfied | 33 (10.7) | < 0.001 | – | – | – | – |
| Neither | 25 (8.5) | < 0.001 | 0.06 | – | – | – |
| Dissatisfied | 18 (6.9) | < 0.001 | < 0.001 | 0.99 | – | – |
| Very dissatisfied | 27 (16.0) | 0.006 | 1.0 | 1.0 | 1.0 | – |
OSS: Oxford shoulder score; ANOVA: analysis of variance.
ROC curve analysis demonstrated that the OSS was a significant predictor of patient satisfaction (p < 0.001) with an area under the curve of 0.888 (Figure 2). The cut point in the OSS to predict patient satisfaction (where sensitivity and specificity are maximal) was illustrated to be a score of 33 (Figure 3).
Figure 2.
A ROC curve for the OSS predicting patient satisfaction with their shoulder at last follow-up (AUC 0.888, 95% CI 0.832–0.945).
ROC: receiver operating characteristic; OSS: Oxford shoulder score; AUC: area under the curve.
Figure 3.
A threshold value of 33 in the post-operative Oxford shoulder score (OSS) offers 81.5% sensitivity and 82.6% specificity in predicting patient satisfaction.
Discussion
Smoking, increasing size of cuff tear and poor general health status as judged by the EQ-5D were independently associated with a worse OSS at medium-term follow after arthroscopic rotator cuff repair. The overall patient satisfaction rate was 90%, smokers and those with poor general health more likely to be dissatisfied. A better OSS was found to be associated with an increased rate of patient satisfaction with a threshold point of 33 or more being associated with a satisfactory outcome.
Predictors of recurrent tears following primary repair include obesity, smoking, hyperlipidemia and co-morbidities.19–21 There is limited research regarding the patient demographic factors that influence the functional outcome and satisfaction of arthroscopic rotator cuff repair. Increasing age, larger tears, biceps or acromioclavicular additional procedures and workers compensation have been associated with inferior post-operative functional outcomes in two recent systematic reviews.12,13 The ongoing impact of such factors at medium-term follow-up is poorly understood.
Our study recruited 234 patients that were followed up at a minimum of 4 years. Adjusting for confounding factors, we have shown that tear size has a negative impact on medium-term functional outcome. This is consistent with findings from Kluger who found increasing tear size was associated with an increased likelihood of re-rupture and inferior outcome. 22 Interestingly although shoulder function is thought to be inferior with re-rupture patient satisfaction is often unaffected.5,13 Presumably sustained pain relief and improved function persist despite a re-rupture which is often attributed to the suspension bridge theory of cuff function. 23
Smoking has been shown to be detrimental in both healing of soft tissue and fractures. 24 In relation to rotator cuff repair, our study is in keeping with previous findings in which smokers were shown to have decreased function above the minimal clinical important difference on the OSS, 11 satisfaction and higher post-operative pain.25–27 It has previously been hypothesized that this could be due to poor healing from hypo-vascularisation or from impaired collagen deposition.25,28 The results of this can be applied in pre-operative management of patients by delivering smoking cessation advice that may result in better satisfaction and outcome.
We found post-operative function was significantly less in those with a worse EQ-5D score, suggesting that those with a better baseline function will achieve better functional results. We were able to identify lung disease, neurological disease and back pain as specific co-morbidities associated with worse post-operative function. An association has been demonstrated between pre-operative function, general health status, pain and the patient's number of co-morbidities.29–31 Alternatively, a lower post-operative functional score may impact on the general quality of life as measured by the EQ-5D. Unfortunately, this relationship is unclear from our results as we did not collect pre-operative scores.
Ninety percent of patients were satisfied with the outcome of their operation at a mean of 5 years post-surgery. Patient demographics for age and gender did not influence post-operative satisfaction in this study, reinforcing results of previous work.4,27,32 The link between function and level of satisfaction is known to correlate positively. 31 Our study used the OSS to assess function and found that higher scores were associated with an increased rate of patient satisfaction. This highlights the importance of function when determining necessity for operation. Many operations are carried out as a means of pain relief but this study has demonstrated that function plays a vital role in improving the patient's perceived quality of life. By determining factors that have an influence on post-operative function, patients can be advised on how to manage aspects of their lifestyle in order to achieve the best results. Clearly, factors such as tear size cannot be altered. However, if patients can be assisted in optimising their physical and psychological health prior to an operation, they can be assured that they are more likely to achieve a positive post-operative outcome.
This study does have its limitations. Pre-operative data was not collected we were therefore unable to compare pre- and post-operative EQ-5D and OSS scores. Additional patient information such as cholesterol level would have been of interest but were not recorded pre-operatively. No formal examination or further imaging was undertaken in our cohort, and we are likely to underestimate the influence of recurrent tears as routine post-operative imaging was not undertaken unless clinically relevant. There could also be participation bias in those patients that chose to respond to the follow-up. Although patient demographics were similar between responders and non-responders, intrinsic differences in patient motivation and perceived satisfaction of treatment outcome in patients that responded may skew our results.
In conclusion, post-operative general health status and smoking were independent predictors of functional outcome and patient satisfaction at medium-term follow-up following arthroscopic rotator cuff repair. Awareness of these patient specific predictors may be useful for pre-operative counselling. Inferior outcome is more likely at 5 years post-surgery in the presence of a large cuff tear, poor general health status and smoking.
Footnotes
Contributorship: OL contributed to idea concept, processed data, statistical analysis and writing manuscript. JAN contributed to idea concept, processed data, writing manuscript and editing manuscript. NDC contributed to idea concept, processed data, statistics, writing manuscript and editing manuscript. WR contributed to idea concept, processed data and editing manuscript. DJM contributed to collecting data, reading and editing manuscript. JM performed surgeries, gathered data, and contributed to reading and editing manuscript.
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: The senior author (J. McBirnie) has an educational contract with Arthrex and Smith & Nephew. The Department of Orthopaedic Surgery, University of Edinburgh has a Shoulder Fellow funded by Arthrex.
Ethical Review and Patient Consent: This study had prospective ethical approval from our regional ethics department as outlined in the manuscript, South East Scotland, National Health Service (NHS) Institute for Health Research REC 16/SS/0026. All patients gave written consent to take part in this study.
Funding: The authors received no financial support for the research, authorship and/or publication of this article.
Guarantor: JAN.
ORCID iD: Jaimie A Nicholson https://orcid.org/0000-0003-3640-8254
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