Health-related quality of life and subjective outcome after shoulder replacement for proximal humeral fractures Roberto Padua, MD,a Rosaria Bondı`, MD,a Enrico Ceccarelli, MD,a Andrea Campi, MD,a and Luca Padua, MD,b,c Rome, Italy
Shoulder replacement has increased exponentially in recent decades, and previous studies have documented the effectiveness of this procedure. Pain relief, physical functional level, and health-related quality of life, however, were often not assessed. To our knowledge, no published articles have assessed quality of life in shoulder replacement for fracture. The main purpose of this study was to assess the patient-relevant outcomes in patients who underwent shoulder replacement for proximal humeral fractures. Standardized quality of life and shoulder-specific, self-administered questionnaires were used. On the Medical Outcomes Study Short Form 36 Health Survey, as expected, we observed a lower score in the domain compared with healthy Italian subjects. A surprising finding was that in the General Health and Role-Emotional domains, our sample had a better picture than the healthy one, probably because patients had experienced severe trauma and major surgery previously. These data represent the first step toward the definition of outcome for this procedure. This study does not address the necessity of therapy, but if this were included in future publications, it might provide useful data for therapeutic recommendations. (J Shoulder Elbow Surg 2008;17:261-264.)
Shoulder replacement has increased exponentially in recent decades owing to good results reported in the literature and improvement of surgical technique and implant design. It is generally performed in patients with shoulder arthritis and for those with humeral head fractures classified as Neer 3 and 4 fragment fractures. In both instances, shoulder surgery outcome may affect the patient’s quality of life (QOL).
From the aOrthopedics Department, San Giacomo Hospital; and b Fondazione don Gnocchi and cInstitute of Neurology, Catholic University of Rome. Reprint requests: Roberto Padua, MD, Via E Gianturco 4, 00196 Rome, Italia (E-mail:
[email protected]). Copyright ª 2008 by Journal of Shoulder and Elbow Surgery Board of Trustees. 1058-2746/2008/$34.00 doi:10.1016/j.jse.2007.06.021
Previous studies document the effectiveness of shoulder replacement in fractures, assessing objective indicators such as range of motion and radiographic images and evaluating the postoperative complications and subsequent revisions.2,3,7,11,16,17 Pain relief, physical function level, and health-related QOL improvement are often left out. Few articles have assessed QOL in shoulder replacement for arthritis,5,7,10 and, to our knowledge, none for fracture. This study collected the patient-relevant outcomes in a homogeneous sample of patients who underwent shoulder replacement for proximal humeral fractures. Standardized scales, such as the Medical Outcomes Study Short Form 36 (SF-36) Health Survey, and sitespecific questionnaires were chosen to assess QOL and shoulder symptoms (function and pain) from the patients’ perspective. MATERIALS AND METHODS Patients Between 2001 and 2003, a prospective study was performed on 21 consecutive patients (18 women, 3 men) surgically treated with shoulder hemiarthroplasty for proximal humeral fractures. The mean patient age was 70 years (range, 57-82 years). The dominant side was involved in all cases. The same surgeon operated on all patients using a deltopectoral approach. Three different prostheses were used according to age. For patients younger than age 75 we used the Cofield (Smith and Nephew, Memphis, TN) and Bigliani/Flatow prosthesis (Zimmer, Warsaw, IN) because a modular implant allows implantation of a glenoid component in the future; for those older than 75 we used the Neer (3M, St Paul, MN) prosthesis. At follow-up, patients were studied a mean 41 months (SD, 6.83 months; range, 2-4 years) after surgery. Patients with 3 or 4 fragment fractures were included in the study. We excluded those patients with neurologic impairment that could involve the final outcome, joint function, and instability. This criterion was used to exclude 1 patient who had posttraumatic brachial plexus palsy (axonal subtotal damage of the overall plexus was diagnosed associated with denervation of the deltoid). Four patients with a transitory peripheral neurologic impairment were included in the series. Patients were evaluated with radiographs (trauma series). Computed tomography scans were performed
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when the head and fragment position was not clear on x-ray film. Clinical examination included neurologic examination, especially for the axillary nerve, and when necessary, an extensive neurophysiologic examination was performed as in a previously published protocol.13
Surgical technique Surgery was performed with the patient in the beach chair position with the arm draped completely free. A standard deltopectoral approach was used. The fracture anatomy was identified with particular attention to the tuberosity fragments. After resection of the humeral head, the glenoid was inspected to evaluate the presence of damage. The prosthesis was inserted in approximately 30 of retroversion according to the individual anatomic characteristics. Cement fixation was used in 16 cases and uncemented fixation in 5. This choice depended on the position of prosthesis, the quality of the bone stock, and the stability of the stem. The greater and lesser tuberosities were carefully reattached to the humeral shaft and prosthesis by heavy nonabsorbable transosseous sutures. The patient’s arm was placed in a slightly flexed and abducted position for 3 weeks. A standardized postoperative protocol, following Neer’s recommendations,12 was used under supervision of a physiotherapist. Passive range of motion began 2 or 3 weeks after surgery. Two independent examiners evaluated all patients clinically and radiographically. Each examiner was an orthopedist trained in upper limb surgery or trauma. Clinical assessment was based on a structured interview, including filling out questionnaires administered by standardized methodologies.
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Table I Patient-oriented results of assessment instruments Instrument
Mean
SD*
SF-36 domains Physical Function Role-Physical Bodily Pain General Health Vitality Social Function Role-Emotional Mental Health Physical Composite Score Mental Composite Score DASH OSQ ASES SST
61.43 42.86 55.86 66.86 65 68.14 52.43 66.86 41.14 47.29 39.29 27.71 73.86 6.57
31.05 47.25 25.45 17.4 27.84 21.59 50.41 29.82 8.315 17.88 19.43 10.31 25.98 3.51
ASES, American Shoulder and Elbow Surgeons questionnaire; DASH, Disability of Arm, Shoulder and Hand; OSQ, Oxford Shoulder Questionnaire; SD, standard deviation; SF-36, Medical Outcomes Study Short Form 36 Health Survey; SST, Simple Shoulder Test. *Standard deviation range is 0-100 except SST, which is 0-10.
Quality-of-life assessment The SF-36, the Disability of Arm, Shoulder and Hand (DASH) questionnaire, which is the most used generic health tool in orthopaedics,1,8,14,18 the American Shoulder and Elbow Surgeons (ASES questionnaire), the Oxford Shoulder Questionnaire (OSQ),6,15 and the Simple Shoulder Test (SST)9 were chosen. The combination of a generic tool and disease-specific scales represents the best outcome assessment of the patient’s perspective.18
The SF-36 has 8 specific physical and emotional domains—Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health—and 2 main scores, the Physical Composite Score and the Mental Composite Score. A very low Physical Composite Score indicates severe physical dysfunction, disabling bodily pain, frequent fatigue, and an unfavorable evaluation of health status. A very low Mental Composite Score indicates frequent psychologic distress and severe social and role disability because of emotional problems.1,18 The DASH questionnaire consists of 30 questions about symptoms and function of the upper limbs that are affected by orthopedic or neurologic disorders. It provides a single main score, the DASH function/symptom score, which is a summation of the responses on a scale of 1 to 5, with 0 (no disability)
to 100 (severe disability). The questions test the degree of difficulty in performing a variety of physical activities because of arm, shoulder, or hand problems (21 items). They also investigate the severity of pain, activity-related pain, tingling, weakness, and stiffness (5 items), as well as the effect of the upper limb problem on social activities, work, sleep, and self-image (4 items).8,14 The Oxford Shoulder Questionnaire (OSQ) is a sitespecific tool that contains 12 items. It is widely used to assess shoulder symptoms and functions. In particular, the OSQ provides a single score, which is an arithmetic average of the responses on a scale of 1 to 5, scored 12 (no disability) to 60 (severe disability).6,15 The ASES scoring system is based on pain (according to a visual analog scale) and function (evaluated by the ability to perform 10 activities of daily living). The SST is a standardized shoulder-specific, selfassessment tool.9 It has 12 yes or no questions that were derived from common presenting complaints of patients with shoulder conditions.
A comprehensive clinical evaluation was performed. A blinded clinical examination was performed by a physician who had some previous contact with the patients but without seeing the radiographs or knowing the results of the questionnaires. The physical capacities and the passive and active range of motion were recorded on a specific form. A comprehensive imaging evaluation was performed. True anteroposterior and axillary views were performed to detect pseudoarthrosis or migration of the tuberosities.
Statistical analysis Statistical analysis was performed by using the Stat-Soft (Tulsa, OK) and SPSS 8.0 (SPSS Inc, Chicago, IL) software
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Table II The correlation among subjective data of Medical Outcomes Study Short Form 36 Health Survey* SF-36 Domains PF
RP
BP
GH
VT
SF
RE
MH
PCS
MCS
DASH
OSQ
ASES
SST
0.56y 0.52 0.64y 0.66y
0.87y 0.84y 0.88y 0.86y
0.91y 0.95y 0.92y 0.88y
0.21 0.22 0.3 0.06
0.71y 0.76y 0.67y 0.61y
0.74y 0.68y 0.68y 0.56y
0.84y 0.86y 0.84y 0.78y
0.60 0.75y 0.55 0.52
0.77y 0.67y 0.84y 0.83y
0.58 0.67y 0.52 0.47
1y 0.93y 0.99y 0.94y
0.93y 1y 0.99y 0.94y
0.99y 0.99y 1 0.96y
0.94y 0.94y 0.96y 1
DASH OSQ ASES SST
ASES, American Shoulder and Elbow Surgeons questionnaire; BP, Bodily Pain; DASH, Disability of Arm, Shoulder and Hand; GH, General Health; MCS, Mental Composite Score; MH, Mental Health; OSO, Oxford shoulder questionnaire; SF-36, Medical Outcomes Study Short Form 36 Health Survey; PCS, Physical Composite Score; PF, Physical Function; RE, Role-Emotional; RP, Role-Physical; SF, Social Function; SST, Simple Shoulder Test; VT, Vitality. *Spearman rank correlation coefficient. Range: 0, no correlation; 1, maximum correlation. y P < .05.
Table III Range of motion of shoulder detected by average of the 2 examiners results Variable*
Mean
SD
Active elevation Passive elevation Active abduction Passive abduction Active external rotation Passive external rotation Internal rotation
112.67 126 87.50 93,33 45.66 50.22 L2
38.82 35.22 48.35 46.44 25.60 26.72 T11-GTy
*Data are presented in degrees, except for internal rotation. y This value is the range.
packages. The Kolmogorov-Smirnov and Lilliefors probability tests were used to assess distribution. Because ordinal or nominal scales were used for measurement, nonparametric analysis of the correlation was assessed by the Spearman rank correlation coefficient. To compare the SF-36 scores of a different population, the sample t test was used. Where standard deviation (SD) was not reported, we assume that SD is the same as in our sample.
RESULTS Table I summarizes the subjective results. The correlation between the SF-36, DASH, OSQ, ASES, and SST values are summarized in Table II. With significance set at P < .05, there is a correlation among the SF-36, DASH, OSQ, ASES, and SST in most of the domains. The analysis between our patients and the healthy Italian population matched by age showed significant differences (P < .05) in Role-Physical, General Health, Vitality, and Role-Emotional. Domains, such as General Health and Vitality show better values in our population than in the healthy one. Active range of motion was 113 of elevation, 88 of abduction, 46 of external rotation, and L2 the level in internal rotation. The detailed results are summarized in Table III.
No pseudoarthrosis or migration of tuberosities was observed on imaging studied. DISCUSSION Shoulder replacement is a solution for complex proximal humeral fractures. The most analyzed data in articles are range of motion, radiographic results, and other objective issues.2,4,11,16 Indeed, the literature has paid attention only to technical aspects.4,16,19 In particular, as some authors have demonstrated, healing of the tuberosities and good prosthetic positioning influences the final functional outcome directly and significantly.3,19 After addressing the technical variables, we should turn our attention to what is more relevant for patients through the analysis of QOL and subjective outcomes. Shoulder function is well assessed with a questionnaire regarding patient information about the shoulder; unfortunately, only a few authors have studied subjective data by validated instruments, and none regarding QOL.5,7,10 Recently, QOL measurements have become increasingly important in clinical research. To our knowledge, this is the first report of a homogeneous series of shoulder replacements for complex proximal humeral fractures studied by QOL questionnaires. The SF-36 is widely used for QOL collection data and offers comparability with data in the literature. We compared data from our series with that of a healthy population in literature and with other published series and as expected, our study population had a lower score in the Physical Role domain. A surprising finding was that in General Health and Role-Emotional domains, our population showed better data than the healthy one. This is probably due to the previous occurrence of severe trauma and major surgery. Statistical analysis showed significant differences between our series and the series of Boorman et al5 in Social Functioning (P < .01), Role-Emotional (P < .01), and Mental Health (P < .05). Statistical analysis
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showed significant differences between our series and that of Lo et al10 in Mental Composite Score (P
