Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (ARTHA): a randomized double blinded clinical trial

Objectives: compare an accelerated physiotherapeutic protocol to a conventional physiotherapeutic protocol in total hip arthroplasty patients. Methods: a randomized double blinded clinical trial performed from August 2013 to November 2014. Forty-eight patients diagnosed with hip osteoarthritis submitted to a total hip arthroplasty surgery. An accelerated rehabilitation physiotherapy applied three times a day and start gait training on the first day or standard physiotherapy applied once a day and start gait training on the second or third day of hospitalization. The Merle dAubigné and Postel score (mobility, pain and gait), muscle strength force, range of motion, in hospital stay and time to start of gait training, were the outcomes. Results: the mean age was 64.46 years (10.37 years standard deviation). No differences were observed in age in different genders, and the two randomization groups were homogeneous. In hospital stay was lower in the intervention group compared to the control group, 3 (3-4) days [median (interquartile range)] versus 4 (4-5) days. Time to the start of gait training was early in the intervention group compared to the control group, 1 (1-1) days versus 2 (2-2) days. Higher muscle strength values were observed in the postoperative results in the intervention group compared to the control group for internal rotation, external rotation and abduction. Conclusions: an accelerated physiotherapeutic protocol should be encouraged, because it shows favourable results in gait, muscle strength and length of hospital stay, even upon hospital discharge.


INTRODUCTION
H ip osteoarthritis (OA) affects the locomotor system and leads to pain, disability and functional limitation [1][2][3] . As the procedure of choice in cases with a lack of response to clinical treatments, total hip arthroplasty (THA) is the most common and the optimal procedure for these patients 1,4 .
Despite the excellent results and being considered one of the procedures of the century 5 , THA surgery has a prolonged and often painful rehabilitation 6,7 . These facts can lead to an increased length of hospital stay and increased costs 7 , bringing clinical complications to the patient [8][9][10] .
Beginning in the mid-1990s 11 and introduced in orthopedic procedures by Kehlet 12 , the accelerated recovery protocols aim to improve patients' outcomes and accelerate recovery after THA surgery 13 . However, there is no consensus concerning the best protocols to be applied 14  Envelope Power (simple size) calculator program was used 16 . The level of significance was 5%, and the power of the sample was 95%.
All patients admitted with hip OA and undergoing THA were eligible. Participants who refused to participate, lived in distant cities, had cognitive disorders that impacted understanding and answering the study questions, were operated under any anesthetic approach other than spinal anesthesia and who did not undergo THA for hip OA were excluded. A total of 50 subjects were initially screened, and 48 patients were included in this study. Two participants declined to participate and were excluded.
All patients had not undergone previous physical therapy. In addition, they had not received any form of preoperative analgesia. All patients participating underwent spinal anesthesia and total hip arthroplasty by the same group of surgeons, who used only the posterior approach for surgical access.
Randomization was performed before the beginning of the study by the Hospital Ethics Committee, and a simple randomization process was carried out, using a sealed bag containing the letters A and B. Following the sequence of the randomly selected letters, the allocation of patients was performed when they were admitted to the hospital. Participants who were allocated the letter A received the Standard Assistance Protocol (SAP). Patients who were allocated the letter B received the Accelerated Rehabilitation Protocol (ARP) for THA. Before enrolment, participants were informed that one group would receive the SAP for THA, while the other group would receive the ARP for THA, although none of the groups was informed about their assigned study group.
The SAP randomization group underwent the following assistance: -Day 1) Patients started this approach four hours after the operations, after they had been discharged from the anesthesia recovery unit. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen their muscles (gluteus and thighs). They were oriented to the decubitus changes and how to be out of bed. They practiced 3 repetitions The Merle d'Aubigné and Postel score is composed of a gait, pain and mobility assessments. Each of these items had a maximum score of six (considered best or normal) and a minimum score of one (considered worst or worse change). The hospital discharge criteria for both groups were the absence of pain and an ambulation of more than 150 steps without the aid of others (only using a walker or crutches).

STATISTICAL ANALYSIS
The statistical analysis was conducted using SPSS version 18.0 (SPSS Inc., IBM Corporation, Armonk, NY).
The Kolmogorov-Smirnov test was applied to verify the normal distribution of the variables. Normal quantitative variables are shown as the mean and standard deviation, and non-normal quantitative variables as the median and interquartile range. Qualitative variables are reported as frequencies. An ANOVA test was used to identify age differences between sex and protocol groups. A Levene test was used to assess the homogeneity of the analyzed groups. To verify differences in sex group distributions between the groups, the differences in how the lower limb was operated between the protocol groups and the difference in the incidence of deep venous thrombosis a Pearson chi-square test was used.
To identify differences in the in hospital stay and time to  Table I. The mean age of the study population was 64.46 ± 10.37 years. There were no age differences between the randomization groups (p=0.879), and they were considered homogeneous (p=0.915). There were also no age differences between sexes (p=0.084), and the sex groups were homogeneous (p=0.310). No age differences were observed between sexes in the same randomization group (p=0.223 for the ARP group and p=0.243 for the SAP group), and all groups were considered homogenous (p=0.084 and p=0.989, respectively). No differences were found for sex distribution within groups (p=0.753).

Marchisio
Accelerated rehabilitation versus conventional rehabilitation in total hip arthroplasty (artha): a randomized double blinded clinical trial

DISCUSSION
The principles of accelerated recovery protocols are to improve patient outcomes and accelerate recovery following surgery 13 . This approach began in the mid-1990s encompassing, colorectal surgical patients 11 . Kehlet 12 was one of the leading names that brought these principles to hip and knee arthroplasty procedures.
Goniometry results are shown in Table 3.  Table 4. There were no significant improvements in the muscular groups in the SAP group (within group comparison). On the other hand, a significant improvement was seen for the abduction and external rotation in the ARP group (within group comparison).
A comparison of postoperative results between the two groups with an interaction of hospital stay time showed a significant difference with higher scores for subjects who were in the ARP group. Higher scores were found in three important muscle groups: abduction (p=0.019), external rotation (p=0.002) and internal rotation (p=0.045).
However, there has been no consensus concerning the physiotherapeutic protocols that can be used. The ARPs take into account the overall concept of patient education, sometimes standardized perioperative anesthesia and local anesthetic infiltration, early mobilization and multimodal analgesia 14 . Some studies 13,15 emphasize and describe only the preoperative and postoperative protocols of multimodal analgesia, while they forget to emphasize the used physiotherapeutic approach. To our knowledge, our study is one of the few 20 to address the physiotherapeutic protocol to be used with these patients. After the THA surgery, the patient still presents function disorders, such as a decreased range of motion and muscle strength, postural and ambulation changes, due to motor imbalance. For these reasons, the ARP is justified, because it optimizes the function of these patients and provides an early return to daily living activities 4,21,22 .
According to Jorgensen et al. 23 and Husted et al. 24 , hospital stay has changed over the years. In Denmark, in the mid-2000s, patients who underwent THA surgery remained in the hospital for about 10 days 25 . However, it is expected that the ARPs lead to a decreased hospital stay 4,21,22 . Some authors report that the estimated hospital stay is about four days with this approach 23,24,[26][27][28] . The Danish Department of Orthopaedic Surgery, considering the real decrease in the hospital stay, began to recommend, from mid-2010, the use of ARPs 11,24 . It is also expected that the number of complications, such as thromboembolic events and risk of hospital infection, would simultaneously decrease with the implementation of the ARPs and the reduction in length of hospital stay [8][9][10] . Our data have shown that the hospitalization time is shorter in patients who received the ARP compared to those who received the SAP. Although most of these adverse events have not been statistically different, except for the presence of deep venous thrombosis, we did not see any clinical differences regarding the incidence of these complications, similar to what other authors have reported [29][30][31][32] . Some articles also report the female sex as a risk factor for increased length of stay 28,33-38 , but this finding was not statistically confirmed by our data.
It was observed that the time to start the gait training was different between the groups. This was one of the initial objectives of the study, to early start gait training in the ARP group, which has been also shown by other authors 39,40 . It was not really known whether this goal would be achieved, since it depended on the patient's perception of safety and on the absence of pain.
Some studies, in order to implement early gait training, performed local capsular tissue and tendon anesthesia during surgery 13,41 . Other authors have reported that patients used pain-blocking medication after the operation such as Pregabalin and Gabapentin, which acts differently to block pain. This approach is known as multimodal analgesia 12,42,43 . However, Smith et al. 31 showed that the early onset of gait training (i.e., on the same day of surgery) decreased the related pain rates during hospitalization. Following the idea of Smith et al. 31 who advocate the non-use of a pharmacological approach (neither local anesthesia nor multimodal analgesia), we decided to start the gait training and maintain the same standard of postoperative analgesia which was routinely used in our hospital. This consists of intravenous Dipyrone 1g every six hours, Tramadol Hydrochloride 100mg diluted in 100mL of saline solution intravenously every eight hours and Morphine Sulfate 5mg subcutaneously every six hours. This type o analgesia allowed similar Merle d'Aubigné and Postel's pain scores of, indicating that both groups had a statistically significant improvement. Therefore, in the ARP group, there was an early start of gait training (on the same day of surgery).
Our study demonstrated an improvement in the range of movements in the ARP group, comparing preoperative to postoperative results (although this was not statistically significant). Compared to the study by Peak et al. 44 , our results for motion range were very poor, even in the ARP group. This might be explained because our assessments were carried out on the day of hospital discharge, while Peak et al. 44 undertook this assessment six weeks after the operation. Therefore, their patients had a longer time to recover their motion range and perform physiotherapy, ultimately demonstrating higher values at the time of re-evaluation, unlike the patients in our study who had a shorter time to improve their range of motion. There is a lack of studies that shows a short-term evaluation of the motion range after ARP. To our knowledge, our study is the only one that has demonstrated this assessment.
An adequate rehabilitation is sought after THA surgery and suitable muscle strength, especially in the abductors, is essential for a good rehabilitation 45 . In other studies, it was observed that muscle strength force decreases in the initial days after THA surgery due to inactivity or pain 46,47 . We found a statistically significant improvement comparing the preoperative and postoperative results in internal rotation, external rotation and abduction in the ARP group, and the ARP group was superior to the SAP group. This clearly demonstrates that the purpose of our study and that which is considered essential for THA rehabilitation 1,48 has been achieved.

STUDY LIMITATIONS
Our study did not perform multimodal analgesia before and after surgery, but the focus of our study was an accelerated physiotherapeutic and non-analgesic approach. We also did not evaluate the surgical approach (the anterior approach in the case, since the group uses only the posterior approach, as well as incisions shorter than 10 cm), since we do not believe that the approach influences the rapid recovery of patients after arthroplasty, which is evidenced by the systematic review of Sharma et al. 4

CONCLUSION
Finally, we consider that accelerated rehabilitation, as performed in our randomized doubleblinded clinical trial, leads, in a short follow-up time evaluation (discharge hospital date), to a decreased in length of stay, early onset of gait training, and increased strength of some hip muscles. We believe that the accelerated approach advocated in our study for postoperative total hip prosthesis should be encouraged because of its positive earlier results and patient benefits as well as the easy application of our protocol by physiotherapists.