Between 1978 and 1986, 59 patients received a GSB III elbow prosthesis, six of them in both elbows. Rheumatoid arthritis (RA) was the underlying cause in 51 of the patients and post-traumatic osteoarthritis (PTOA) in eight. Of these, 24 patients (28 prostheses) have since died; two, both operated on bilaterally, had had their implants for more than ten years and had already been assessed for inclusion in the long-term follow-up. Two patients, each with one elbow prosthesis, have been lost to follow-up and three males who are still living (two with PTOA, one with juvenile RA) had their prosthesis removed before ten years had elapsed. The remaining 32 patients (28 RA, 4 PTOA) with 36 GSB III elbows were examined clinically and radiologically after a mean period of 13.5 years. Pain was considerably reduced in 91.6%. Mobility was increased by 37° in those with RA and by 67° in those with PTOA. There were three cases of aseptic loosening and three of deep infection. The main complication was disassembly of the prosthetic component in nine elbows (13.8%). This last group included two patients with postoperative fractures unrelated to the operative technique and one with neuropathic arthritis. Ulnar neuritis occurred in two patients. Since 87.7% of all the GSB III prostheses implanted in this period remained in situ, our results are comparable with those for hip and knee arthroplasty.
The purpose of this study was to assess the clinical
and radiological outcomes of dorsal intercarpal ligament capsulodesis
for the treatment of static scapholunate instability at a minimum
follow-up of four years. A total of 59 patients who underwent capsulodesis
for this condition were included in a retrospective analysis after
a mean of 8.25 years (4.3 to 12). A total of eight patients underwent
a salvage procedure at a mean of 2.33 years (0.67 to 7.6) and were
excluded. The mean range of extension/flexion was 88° (15° to 135°)
and of ulnar/radial deviation was 38° (0° to 75°) at final follow-up.
The mean Disabilities of the Arm Shoulder and Hand (DASH) score
and Mayo wrist scores were 28 (0 to 85) and 61 (0 to 90), respectively Capsulodesis did not maintain carpal reduction over time. Although
the consequent ongoing scapholunate instability resulted in early
arthritic degeneration, most patients had acceptable long-term function
of the wrist.
We report the long-term clinical and radiological outcomes of the Aequalis total shoulder replacement with a cemented all-polyethylene flat-back keeled glenoid component implanted for primary osteoarthritis between 1991 and 2003 in nine European centres. A total of 226 shoulders in 210 patients were retrospectively reviewed at a mean of 122.7 months (61 to 219) or at revision. Clinical outcome was assessed using the Constant score, patient satisfaction score and range of movement. Kaplan-Meier survivorship analysis was performed with glenoid revision for loosening and radiological glenoid loosening ( Younger patient age and the curettage technique for glenoid preparation correlated with loosening. The rate of glenoid revision and radiological loosening increased with duration of follow-up, but not until a follow-up of five years. Therefore, we recommend that future studies reporting radiological outcomes of new glenoid designs should report follow-up of at least five to ten years.
We present the long-term outcome, at a median of 18 years (12.8 to 23.5) of open posterior bone block stabilisation for recurrent posterior instability of the shoulder in a heterogenous group of 11 patients previously reported on in 2001 at a median follow-up of six years. We found that five (45%) would not have chosen the operation again, and that four (36%) had further posterior dislocation. Clinical outcome was significantly worse after 18 years than after six years of follow-up (median Rowe score of 60 versus 90 (p = 0.027)). The median Western Ontario Shoulder Index was 60% (37% to 100%) at 18 years’ follow-up, which is a moderate score. At the time of surgery four (36%) had glenohumeral radiological osteoarthritis, which was present in all after 18 years. This study showed poor
We report the outcome of a modified Bankart procedure using suture anchors in 31 patients (31 shoulders) with a mean follow-up of 11 years (10 to 15). The mean age of the patients was 28 years (16 to 39). At follow-up, the mean Rowe score was 90 points (66 to 98) and the Constant score was 96 points (85 to 100). A total of 26 shoulders (84%) had a good or excellent result. The rate of recurrence varied between 6.7% and 9.7% and depended on how recurrence was defined. Two patients had a significant new injury at one and nine years, respectively after operation. The overall rate of instability (including subluxations) varied between 12.9% and 22.6%. All patients returned to work, with 29 (94%) resuming their pre-operative occupation and level of activity. Mild radiological osteoarthritis was seen in nine shoulders (29%) and severe osteoarthritis in one. We conclude that the open modified Bankart procedure is a reliable surgical technique with good
Between September 1993 and September 1996, we performed 34 Kudo 5 total elbow replacements in 31 rheumatoid patients. All 22 surviving patients were reviewed at a mean of 11.9 years (10 to 14). Their mean age was 56 years (37 to 78) at the time of operation. All had Larsen grade IV or V rheumatoid changes on X-ray. Nine (three bilateral replacements and six unilateral) had died from unrelated causes. One who had died before ten years underwent revision for dislocation. Of the 22 total elbow replacements reviewed six had required revision, four for aseptic loosening (one humeral and three ulnar) and two for infection. Post-operatively, one patient had neuropraxia of the ulnar nerve and one of the radial nerve. Two patients had valgus tilting of the ulnar component. With revision as the endpoint, the mean survival time for the prosthesis was 11.3 years (95% confidence interval (10 to 13) and the estimated survival of the prosthesis at 12 years according to Kaplan-Meier survival analysis was 74% (95% confidence interval 0.53 to 0.91). Of the 16 surviving implants, ten were free from pain, four had mild pain and two moderate. The mean arc of flexion/extension of the elbow was 106° (65° to 130°) with pronation/supination of 90° (30° to 150°) with the joint at 90° of flexion. The mean Mayo elbow performance score was 82 (60 to 100) with five excellent, ten good and one fair
The purpose of this study was to assess the
Restoration of hand function is rarely achieved after a complete closed traction lesion of the supraclavicular brachial plexus. We describe the injury, treatment, rehabilitation and
We assessed the
Spinal accessory nerve palsy leads to painful disability of the shoulder, carrying an uncertain prognosis. We reviewed the long-term outcome in 16 patients who were treated for pain, weakness of active elevation and asymmetry of the shoulder and the neck due to chronic paralysis of the trapezius muscle, as a result of nerve palsy. Of four patients who were treated conservatively, none regained satisfactory function, although two became pain-free. The other 12 patients were treated operatively with transfer of the levator scapulae to the acromion and the rhomboid muscles to the infraspinatus fossa (the Eden-Lange procedure). At a mean follow-up of 32 years, the clinical outcome of the operatively treated patients was excellent in nine, fair in two, and poor in one patient, as determined by the Constant score. Pain was adequately relieved in 11 and overhead function was restored in nine patients. Pre-operative electromyography had been carried out in four patients. In two, who eventually had a poor outcome, a concomitant long thoracic and dorsal scapular nerve lesion had been present. The Eden-Lange procedure gives very satisfactory
We analysed the
There are no
Injectable Bromelain Solution (IBS) is a modified investigational derivate of the medical grade bromelain-debriding pharmaceutical agent (NexoBrid) studied and approved for a rapid (four-hour single application), eschar-specific, deep burn debridement. We conducted an Specially prepared medical grade IBS was injected into fresh Dupuytren’s cords excised from patients undergoing surgical fasciectomy. These cords were tested by tension-loading them to failure with the Zwick 1445 (Zwick GmbH & Co. KG, Ulm, Germany) tension testing system.Objectives
Materials and Methods
We present the electromyographic (EMG) results
ten years after open decompression of the median nerve at the wrist
and compare them with the clinical and functional outcomes as judged
by Levine’s Questionnaire. This retrospective study evaluated 115
patients who had undergone carpal tunnel decompression at a mean
of 10.47 years (9.24 to 11.36) previously. A positive EMG diagnosis
was found in 77 patients (67%), including those who were asymptomatic
at ten years. It is necessary to include both clinical and functional results
as well as electromyographic testing in the long-term evaluation
of patients who have undergone carpal tunnel decompression particularly
in those in whom revision surgery is being considered. In doubtful
cases or when there are differing outcomes, self-administered scales
such as Levine’s Questionnaire should prevail over EMG results when
deciding on the need for revision surgery.
The aim of this study was to compare a third-generation
cementing procedure for glenoid components with a new technique
for cement pressurisation. In 20 pairs of scapulae, 20 keeled and
20 pegged glenoid components were implanted using either a third-generation
cementing technique (group 1) or a new pressuriser (group 2). Cement penetration
was measured by three-dimensional (3D) analysis of micro-CT scans.
The mean 3D depth of penetration of the cement was significantly
greater in group 2 (p <
0.001). The mean thickness of the cement
mantle for keeled glenoids was 2.50 mm (2.0 to 3.3) in group 1 and
5.18 mm (4.4 to 6.1) in group 2, and for pegged glenoids it was 1.72 mm
(0.9 to 2.3) in group 1 and 5.63 mm (3.6 to 6.4) in group 2. A cement
mantle <
2 mm was detected less frequently in group 2 (p <
0.001). Using the cement pressuriser the proportion of cement mantles
<
2 mm was significantly reduced compared with the third-generation
cementing technique.
The outcome of an anatomical shoulder replacement
depends on an intact rotator cuff. In 1981 Grammont designed a novel
large-head reverse shoulder replacement for patients with cuff deficiency.
Such has been the success of this replacement that it has led to
a rapid expansion of the indications. We performed a systematic
review of the literature to evaluate the functional outcome of each
indication for the reverse shoulder replacement. Secondary outcome
measures of range of movement, pain scores and complication rates
are also presented.
The combination of an irreparable tear of the rotator cuff and destructive arthritis of the shoulder joint may cause severe pain, disability and loss of independence in the aged. Standard anatomical shoulder replacements depend on a functioning rotator cuff, and hence may fail in the presence of tears in the cuff. Many designs of non-anatomical constrained or semi-constrained prostheses have been developed for cuff tear arthropathy, but have proved unsatisfactory and were abandoned. The DePuy Delta III reverse prosthesis, designed by Grammont, medialises and stabilises the centre of rotation of the shoulder joint and has shown early promise. This study evaluated the mid-term clinical and radiological results of this arthroplasty in a consecutive series of 50 shoulders in 43 patients with a painful pseudoparalysis due to an irreparable cuff tear and destructive arthritis, performed over a period of seven years by a single surgeon. A follow-up of 98% was achieved, with a mean duration of 39 months (8 to 81). The mean age of the patients at the time of surgery was 81 years (59 to 95). The female to male ratio was 5:1. During the seven years, six patients died of natural causes. The clinical outcome was assessed using the American Shoulder and Elbow score, the Oxford Shoulder Score and the Short-form 36 score. A radiological review was performed using the Sirveaux score for scapular notching. The mean American Shoulder and Elbow score was 19 (95% confidence interval (CI) 14 to 23) pre-operatively, and 65 (95% CI 48 to 82) (paired The mean maximum elevation improved from 55° pre-operatively to 105° at final follow-up. There were seven complications during the whole series, although only four patients required further surgery.
Fractures of the proximal humerus can lead to malalignment of the humeral head, necrosis and post-traumatic osteoarthritis. In such cases surface replacement might be a promising option. A total of 28 shoulders with glenohumeral arthritis subsequent to a fracture underwent surface replacement arthroplasty of the humeral head in patients with a mean age of 60 years (35 to 83). On the basis of the inclination of the impacted head, post-traumatic arthritis was divided into three types: type 1, an impacted fracture of the head in an anatomical position (seven cases); type 2, a valgus impacted fracture (13 cases); type 3, a varus impacted fracture (eight cases). The outcome was measured by means of the Constant score. According to the Boileau classification of the sequelae of fractures of the proximal humerus, all 28 patients had a final result of intra-capsular category 1. The mean Constant score for the 28 shoulders increased from 23.2 points (2 to 45) pre-operatively to 55.1 points (20 to 89) at a mean of 31 months (24 to 66) post-operatively. Valgus impacted fractures had significantly better results (p <
0.039). Surface replacement arthroplasty can provide good results for patients with post-traumatic osteoarthritis of the shoulder. Their use avoids post-operative complications of the humeral shaft, such as peri-prosthetic fractures. Further surgery can be undertaken more easily as the bone stock is preserved.
This is a retrospective review of the results of the Acclaim total elbow replacement in 11 older patients aged ≥ 65 years with primary osteoarthritis of the elbow, with a mean follow-up of 57.6 months (30 to 86.4). Significant reductions in pain and improvement in range of movement and function were recorded. Radiological review revealed two patients with 1 mm lucencies in a single zone, and one patient with 1 mm lucencies in two zones. No components required revision. There were no deep infections, dislocations or mechanical failures. Complications included one intra-operative medial condylar fracture and one post-operative transient ulnar neuropathy, which resolved. This study demonstrates that the Acclaim prosthesis provides good symptomatic relief and improvement of function in patients with primary osteoarthritis, with low rates of loosening or other complications. This prosthesis can therefore be considered for patients aged ≥ 65 years with primary osteoarthritis of the elbow.
Between 1982 and 1997, 403 consecutive patients (522 elbows) with rheumatoid arthritis underwent Souter-Strathclyde total elbow replacement. By the end of 2007, there had been 66 revisions for aseptic loosening in 60 patients. The mean time of follow-up was 10.6 years (0 to 25) The survival rates at five-, ten, 15 and 19 years were 96% (95%, confidence interval (CI) 95 to 98), 89% (95% CI 86 to 92), 83% (95% CI 78 to 87), and 77% (95% CI 69 to 85), respectively. The small and medium-sized short-stemmed primary humeral components had a 5.6-fold and 3.6-fold risk of revision for aseptic loosening respectively, compared to the medium-sized long-stemmed component. The small and medium-sized all-polyethylene ulnar components had respectively a 28.2-fold and 8.4-fold risk of revision for aseptic loosening, compared to the metal-backed ulnar components. The use of retentive ulnar components was not associated with an increased risk of aseptic loosening compared to non-retentive implants.
Excision is not a suitable treatment for all comminuted fractures of the radial head. In elbows where instability can be predicted, a replacement arthroplasty of the radial head is more effective. The aim of this paper was to present the medium-term results of the Judet floating radial head prosthesis. This operation was performed on 14 patients between 1992 and 2003, of whom 12 were reviewed at a mean follow-up of five years and three months (1 to 12 years). The outcome was assessed using the Mayo elbow performance score and a modified Disability of Arm Shoulder Hand (DASH) questionnaire. There were six excellent results, four good, one fair and one poor, as graded by the Mayo score. The mean DASH score was 23.9/100 (0 to 65.8/100). The only significant complication occurred in one patient who developed a severe complex regional pain syndrome. There were no patients with secondary instability of the elbow, implant loosening, cubitus valgus, osteoporosis of the capitellum, or pain in the forearm and wrist. Our experience, combined with that of other authors using this device, has encouraged us to continue using the Judet prosthesis in comminuted fractures of the elbow where instability is a potential problem.
We have investigated the mid-term outcome of total shoulder replacement using a keeled cemented glenoid component and a modern cementing technique with regard to the causes of failure and loosening of the components. Between 1997 and 2003 we performed 96 total shoulder replacements on 88 patients, 24 men and 64 women with a mean age of 69.7 years (31 to 82). The minimum follow-up was five years and at the time of review 87 shoulders (77 patients) were examined at a mean follow-up of 89.1 months (60 to 127). Cumulative survival curves were generated with re-operations (accomplished and planned), survivorship of the proshesis, loosening of the glenoid (defined as tilt >
5° or subsidence >
5 mm), the presence of radiolucent lines and a Constant score of <
30 as the endpoints. There were two re-operations not involving revision of the implants and the survival rate of the prosthesis was 100.0% for the follow-up period, with an absolute Constant score of >
30 as the endpoint the survival rate was 98%. Radiological glenoid loosening was 9% after five years, and 33% after nine years. There was an incidence of 8% of radiolucent lines in more than three of six zones in the immediate post-operative period, of 37.0% after the first year which increased to 87.0% after nine years. There was no correlation between the score of Boileau and the total Constant score at the latest follow-up, but there was correlation between glenoid loosening and pain (p = 0.001). We found that total shoulder replacement had an excellent mid-term survivorship and clinical outcome. The surgical and cementing techniques were related to the decrease in radiolucent lines around the glenoid compared with earlier studies. One concern, however, was the fact that radiolucent lines increased over time and there was a rate of glenoid loosening of 9% after five years and 33% after nine years. This suggests that the design of the glenoid component, and the implantation and cementing techniques may need further improvement.
We analysed the outcome of the Coonrad-Morrey total elbow replacement used for fracture of the distal humerus in elderly patients with no evidence of inflammatory arthritis and compared the results for early One patient in the early group developed chronic regional pain syndrome and another type 4 aseptic loosening. Two elbows in the early group also showed type 1 radiological loosening. Two patients in the delayed group had an infection, two an ulnar nerve palsy, one developed heterotopic ossification and one type 4 aseptic loosening. Two elbows in this group also showed type 1 radiological loosening. The Kaplan-Meier survivorship analysis for the early and delayed treatment groups was 93% at 88 months and 76% at 84 months, respectively. No significant difference was found between the two groups.
In order to compare the outcome from surgical repair and physiotherapy, 103 patients with symptomatic small and medium-sized tears of the rotator cuff were randomly allocated to one of the two approaches. The primary outcome measure was the Constant score, and secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score, the Short Form 36 Health Survey and subscores for shoulder movement, pain, strength and patient satisfaction. Scores were taken at baseline and after six and 12 months by a blinded assessor. Nine patients (18%) with insufficient benefit from physiotherapy after at least 15 treatment sessions underwent secondary surgical treatment. Analysis of between-group differences showed better results for the surgery group on the Constant scale (difference 13.0 points, p − 0.002), on the American Shoulder and Elbow surgeons scale (difference 16.1 points, p <
0.0005), for pain-free abduction (difference 28.8°, p = 0.003) and for reduction in pain (difference on a visual analogue scale −1.7 cm, p <
0.0005).
We describe the outcome at a mean follow-up of 8.75 years (7.6 to 9.8) of seven patients who had undergone osteochondral autologous transplantation for full-thickness cartilage defects of the shoulder between 1998 and 2000. These patients have been described previously at a mean of 32.6 months when eight were included. One patient has been lost to follow-up. The outcome was assessed by the Constant shoulder score and the Lysholm knee score to assess any donor-site morbidity. Standard radiographs and MR scores were obtained and compared with the pre-operative findings and the results from the previous review. No patient required any further surgery on the shoulder. The mean Constant score improved significantly until the final follow-up (p = 0.018). The Lysholm score remained excellent throughout. There was a significant progression of osteoarthritic changes from the initial surgery to the first and final follow-up but this did not appear to be related to the size of the defect, the number of cylinders required or the Constant score (p = 0.016). MRI showed that all except one patient had a congruent joint surface at the defect with full bony integration of all osteochondral cylinders. The results have remained satisfactory over a longer period with very good objective and subjective findings.
Ulnar neuropathy presents as a complication in 5% to 10% of total elbow replacements, but subsequent ulnar neurolysis is rarely performed. Little information is available on the surgical management of persistent ulnar neuropathy after elbow replacement. We describe our experience with the surgical management of this problem. Of 1607 total elbow replacements performed at our institution between January 1969 and December 2004, eight patients (0.5%) had a further operation for persistent or progressive ulnar neuropathy. At a mean follow-up of 9.2 years (3.1 to 21.7) six were clinically improved and satisfied with their outcome, although, only four had complete recovery. When transposition was performed on a previously untransposed nerve the rate of recovery was 75%, but this was reduced to 25% if the nerve had been transposed at the time of the replacement.
We retrospectively reviewed 26 patients who underwent reconstruction of the shoulder for a medial rotation contracture after birth injury of the brachial plexus. Of these, 13 patients with a mean age of 5.8 years (2.8 to 12.9) received an injection of botulinum toxin type A into the pectoralis major as a surgical adjunct. They were matched with 13 patients with a mean age of 4.0 years (1.9 to 7.2) who underwent an identical operation before the introduction of botulinum toxin therapy to our unit. Pre-operatively, there was no significant difference (p = 0.093) in the modified Gilbert shoulder scores for the two groups. Post-operatively, the patients who received the botulinum toxin had significantly better Gilbert shoulder scores (p = 0.012) at a mean follow-up of three years (1.5 to 9.8). It appears that botulinum toxin type A produces benefits which are sustained beyond the period for which the toxin is recognised to be active. We suggest that by temporarily weakening some of the power of medial rotation, afferent signals to the brain are reduced and cortical recruitment for the injured nerves is improved.
The Acclaim total elbow replacement is a modular system which allows implantation in both unlinked and linked modes. The results of the use of this implant in primary total elbow replacement in 36 patients, operated on between July 2000 and August 2002, are presented at a mean follow-up of 36 months (24 to 49). Only one patient did not have good relief of pain, but all had improved movement and function. No implant showed clinical or radiological loosening, although one had a lucent area in three of seven humeral zones. The short-term results of the Acclaim total elbow replacement are encouraging. However, 11 patients (30.5%) suffered an intra-operative fracture of the humeral condyle. This did not affect the outcome, or the requirement for further surgery, except in one case where the fracture failed to unite. This problem has hopefully been addressed by redesigning the humeral resection guide. Other complications included three cases of ulnar neuropathy (8.3%) and one of deep infection (2.8%).
We present the outcome of the treatment of chronic post-traumatic contractures of the proximal interphalangeal joint by gradual distraction correction using an external fixator. A total of 30 consecutive patients with a mean age of 34 years (17 to 54) had distraction for a mean of 16 days (10 to 22). The fixator was removed after a mean of 29 days (16 to 40). Assessment at a mean of 34 months (18 to 54) after completion of treatment showed that the mean active range of movement had significantly increased by 63° (30° to 90°; p <
0.001). The mean active extension gained was 47° (30° to 75°). Patients aged less than 40 years fared slightly better with a mean gain in active range of movement of 65° (30° to 90°) compared with those aged more than 40 years, who had a mean gain in active range of movement of 55° (30° to 70°) but the difference was not statistically significant (p = 0.148). The use of joint distraction to correct chronic flexion contracture of the proximal interphalangeal joint is a minimally-invasive and effective method of treatment.
Between 1993 and 2002, 58 GSB III total elbow replacements were implanted in 45 patients with rheumatoid arthritis by the same surgeon. At the most recent follow-up, five patients had died (five elbows) and six (nine elbows) had been lost to follow-up, leaving 44 total elbow replacements in 34 patients available for clinical and radiological review at a mean follow-up of 74 months (25 to 143). There were 26 women and eight men with a mean age at operation of 55.7 years (24 to 77). At the latest follow-up, 31 excellent (70%), six good (14%), three fair (7%) and four poor (9%) results were noted according to the Mayo elbow performance score. Five humeral (11%) and one ulnar (2%) component were loose according to radiological criteria (type III or type IV). Of the 44 prostheses, two (5%) had been revised, one for type-IV humeral loosening after follow-up for ten years and one for fracture of the ulnar component. Seven elbows had post-operative dysfunction of the ulnar nerve, which was transient in five and permanent in two. Despite an increased incidence of loosening with time, the GSB III prosthesis has given favourable mid-term results in patients with rheumatoid arthritis.
We have performed a form of lunate replacement arthroplasty, which included excision of the lunate and insertion of a vascularised radial bone flap wrapped in pronator quadratus, for stage IIIB or stage IV Kienböck’s disease, in 41 patients who have been followed up for more than three years. All patients reported an improvement in their symptoms, and 20 of the 41 became free of pain after the operation. Extension and flexion of the wrist were increased by a mean of 9° and 6°, respectively (p <
0.05). The radioscaphoid angle and the carpal height ratio were not significantly changed and only minimal deterioration was observed due to degenerative change. The size, density or location of the inserted bone did not change with time. A vascularised radial bone flap wrapped in pronator quadratus can be a reliable treatment option for advanced Kienböck’s disease, when the pedicled bone and muscle envelope acts as a stable spacer for the excised lunate.
We examined the effects of previous resection of the radial head and synovectomy on the outcome of subsequent total elbow arthroplasty in patients with rheumatoid arthritis. Fifteen elbows with a history of resection and synovectomy were compared with a control group of patients who had elbow arthroplasty with an implant of the same design. The mean age in both groups was 63 years. In the study group, resection of the radial head and synovectomy had been undertaken at a mean of 8.9 years before arthroplasty. The mean radiological follow-up for the 13 available patients in the study group was 5.89 years (0.3 to 11.0) and in the control group was 6.6 years (2.2 to 12.6). There were no revisions in either group. The mean Mayo elbow performance score improved from 29 to 96 in the study group, with similar improvement in the control group (28 to 87). The study group had excellent results in 13 elbows and good results in two. The control group had excellent results in seven and good results in six. Our experience indicates that previous resection of the radial head and synovectomy are not associated with an increased rate of revision following subsequent arthroplasty of the elbow. However, there was a higher rate of complication in the study group compared with the control group.