RESEARCHTreatment of Severe Flexion Deficits
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| PURPOSE: To determine whether passive knee flexion and knee- specific outcome scores differ in TKA patients experiencing Arthrofibrosis treated with differing intensity of stretch exercises. DESIGN: Randomized Controlled Trial SAMPLE: Twenty patients who volunteered and met inclusion criteria were randomly assigned to an intervention group. TREATMENT: Group 1 received high-intensity stretch home mechanical therapy (n 11) and Group 2 received low-in- tensity stretch home mechanical therapy (n 9). FINDINGS: The HIS group demonstrated significantly greater gains in both passive knee flexion and outcome scores. The change in passive knee flexion significantly correlated with the change in outcome scores, and a significantly greater number of patients in the HIS group (91%) were able to achieve a functional range of motion 110 than those in the LIS group (22%, p .001). CONCLUSION: Treatment of postoperative Arthrofibrosis with an HIS home mechanical therapy device was more effective and resulted in significantly improved outcomes when com- pared with LIS devices. Introduction Five percent of patients undergoing total knee arthroplasty (TKA) develop severe postoperative motion loss that does not respond to the normal standard of care (Brosseau et al., 2004). The number of TKA procedures expected to be per- formed in the United States in 2010 is more than 660,000 (Kurtz, Ong, Lau, Mowat, & Halpern, 2007), resulting in ap- proximately 33,000 patients who will develop severe postop- erative motion loss. The most common cause for severe post- operative motion loss is the development of intra-articular or extra-articular Arthrofibrosis (Boldt, Munzinger, Zanetti, & Hodler, 2004; Bosch, Zeichen, Skutek, Haeder, & van griens- ven, 2001; Creighton & Bach, 2005; Magit, Wolff, Sutton, & Medvecky, 2007; Maloney, 2002; Mohammed, Syed, & Ahmed, 2009; Seyler et al., 2007). Arthrofibrosis is charac- terized by periarticular fi brosis and the formation of bands of scar tissue between the quadriceps mechanism and the distal femur, and patients often present with de- creased patellofemoral mobi lity (Maloney, 2002). For those TKA patients who have developed postoperative Arthrofibrosis, range of motion (ROM) is limited during knee flexion as these bands of scar tissue prevent excur- sion of the quadriceps mechanism (Maloney, 2002). | Arthrofibrosis may be treated either surgically or conservatively. Surgical interventions are generally successful; however, 20%–25% of patients do not dem- onstrate lasting gains in ROM following motion- restoring surgery and require additional surgical proce- dures (Christensen, Crawford, Olin, & Vail, 2002; Haidukewych, Jacofsky, Pagnano, & Trousdale, 2005). Furthermore, surgical interventions carry slight risks of periprosthetic fracture, quadriceps/patellar tendon rup- ture, or collateral ligament damage, which is considered catastrophic and will likely lead to the need for either revision surgery or knee fusion (Magit et al., 2007). Conservative treatment of Arthrofibrosis often entails intensive outpatient physical therapy. Physical thera- pists use high-intensity overpressure stretching tech- niques to improve joint ROM (Davies & Ellenbecker, 1999; Noyes & Barber-Westin, 2010). Overpressure stretching is performed by applying force to the joint that exceeds the weight of the patient’s limb with the joint at its end ROM. To be effective, these treatments must be performed daily (Davies & Ellenbecker, 1999) to achieve lasting gains in ROM, and daily treatment in an outpatient rehabilitation setting is not often possible. Home mechanical therapy devices can improve ROM and clinical outcomes in patients undergoing TKA by allowing the patient to be treated daily, and patients using home mechanical therapy devices have demon- strated significantly reduced rates of reoperation when compared with patients treated with physical therapy alone (Stephenson, Quimbo, & Gu, 2010). Arthrofibrosis is a diffi cult condition, and daily overpressure stretch- ing may be helpful for improving joint ROM (Davies & Ellenbecker, 1999). By being available to patients with Arthrofibrosis in their own homes, adjunctive use of home mechanical therapy devices allows patients to be treated daily to improve motion and avoid the need for motion-restor- ing surgery (Branch, Karsch, Mills, & Palmer, 2003). Previous authors have demonstrated that home me- chanical therapy devices can be divided into two Treatment of Severe Flexion Defi cits Following Total Knee Arthroplasty A Randomized Clinical Trial Basil A. Papotto ▼ Tim Mills Basil A. Papotto, PT, University Physical Therapy, Decatur, GA. Tim Mills, RN, University Orthopaedics and Sports Medicine, Decatur, GA. The authors declare no confl ict of interest. DOI: 10.1097/NOR.0b013e3182419662 |
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categories: high-intensity stretch (HIS) devices that
apply forces to the joint that mimic the force applied
by physical therapists and low-intensity stretch (LIS)
devices that apply forces similar in magnitude to com-
mon home exercises (Uhl & Jacobs, 2011). The effi cacy
of a stretching regimen has been reported to be related
to the product of the duration of time that stretching is
performed each day, the number of times per day
stretching is performed, and the intensity of the stretch
(Davies & Ellenbecker, 1999; Flowers & LaStayo, 1994;
McClure & Flowers, 1992). Theoretically, both LIS and
HIS devices may improve knee flexion ROM for pa-
tients with Arthrofibrosis following TKA, but the dura-
tion and frequency of stretching will need to be modi-
fi ed to account for differences in the intensity of the
stretch being provided. Low-intensity stretch devices
are generally associated with longer treatment sessions
as well as a greater number of weeks of use than has
been reported with HIS devices (Branch et al., 2003;
Steffen & Mollinger, 1995). As no prospective head-to-
head studies have been performed to date comparing
LIS and HIS mechanical therapy in the treatment of
Arthrofibrosis following TKA, the purpose of this ran-
domized clinical trial was to compare the effi cacy of
adjunctive LIS and HIS home mechanical therapy in a
sample of TKA patients with severe postoperative
Arthrofibrosis.
Materials and Methods Twenty TKA patients older than 65 years who met the inclusion/exclusion criteria volunteered to participate in this institutional review board-approved randomized clinical trial. To test the hypothesis that the change in ROM from baseline to follow-up using an HIS device differs from the ROM and outcomes when using an LIS device, a power analysis suggested that a sample size of 24 would be adequately powered (80%) to detect a mean difference of 12° or more between the two groups speci- fied, assuming a pooled standard deviation of 10° for a two-sided alternative hypothesis and .05. The sam- ple size was calculated using PS: Power and Sample Size, version 3.0 (Department of Biostatistics, Vanderbilt University, Nashville, TN). All patients enrolled were diagnosed with postopera- tive Arthrofibrosis and had f ailed traditional outpatient physical therapy, resulting in knee ROM of 90° or less in the first six postoperative weeks. Participants were recruited from the populations of two board-certified or- thopaedic surgeons and eight licensed physical thera- pists. Patients were excluded if they had sensory deficits that would not allow for the safe use of a home mechani- cal therapy device. Patients were also excluded if they had a history of ipsilateral total hip arthroplasty, as the manu- facturers of the HIS device have indicated that it is con- traindicated for these patients because of the perceived increased risk of hip dislocation due to the axial load being applied to the foot and the flexed position of the hip during treatment. After providing informed consent, sub- jects were randomly assigned to either the HIS or LIS groups (see Figure 1). Random group assignment was de- termined with the use of a computerized random number generator (Excel, Microsoft Corp., Redmond, WA). | HIGH-INTENSITY STRETCH HOME MECHANICAL THERAPY Patients in the HIS group were treated with the ERMI Knee/Ankle Flexionater (ERMI, Inc., Atlanta, GA; see Figure 2). The ERMI Knee/Ankle Flexionater is a seated, hydraulic system that allows patients to apply a great deal of force to the joint with little input force. To use the de- vice, patients pulled a lever to increase the knee flexion angle as well as the amount of torque being applied to the joint. The length of the lever allowed this hydraulic system to amplify the force applied by the patient to the lever into a greater torque being applied to the knee. Patients used the hydraulic pump to move the joint to the end ROM, and the device’s quick-release mechanism gave patients complete control of the intensity of stretch provided. Patients were instructed on the use of the device at the time of study enrollment and were given detailed handouts with both text and visual descriptions of the instructions for use. Patients were asked to use the de- vice multiple sessions per day. Each session was broken into 5- to 10-min increments of stretching followed by 5- to 10-min recovery interval. Stretching was per- formed at the end range of knee flexion, and patients were asked to stretch at an intensity that mimicked the intensity of the stretch being provided by their physical therapists during outpatient therapy sessions. During the recovery interval, patients released the knee back to an extended position. Following the recovery interval, patients performed another stretching interval, again followed by a recovery interval. Patients were asked to repeat the stretch-recovery cycles until 20–30 min had passed, and were asked to repeat treatment sessions until they had achieved 60 min of end-range stretching per day. This treatment protocol has been previously demonstrated to be effective in patients with severe mo- tion loss (Davies & Ellenbecker, 1999; Noyes & Barber- Westin, 2010). LOW-INTENSITY STRETCH HOME MECHANICAL THERAPY Patients in the LIS group were treated with the StaticPro Knee (DeRoyal Industries, Powell, TN; see Figure 3). The brace is applied to thigh and low leg, using a system of cuffs and straps. The patient then increases the torque on the knee, using a hand crank located at the knee. Patients were asked to use the device in three 30-min increments per day and were asked to routinely increase the force applied to the joint every 5 min during each of the 30-min treatment sessions. This device has previ- ously been reported to be a low-intensity device that ap- plies forces to the joint that are far less than that applied by a physical therapist (Uhl & Jacobs, 2011). Both groups were asked to use the devices for a pe- riod of 4–8 weeks. Patients were asked to complete the Western Ontario and MacMaster University (WOMA C) Osteoarthritis Index at both the initial visits at which they were diagnosed with Arthrofibrosis and enrolled in the study, as well as at the visit immediately after the treatment period. The WOMAC Osteoarthritis Index is an outcome-scoring tool that consists of 24 items divided into stiffness (two items), pain (fi ve items), and physical function (17 items) subscales. Using a 5-point |
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| Likert scale, the patient scores each item, and the WOMAC scores range from 0 to 100, with 100 being the best possible score (no pain or disfunction). The WOMAC has been reported to have excellent internal | consistency and test–retest reliability (Bellamy, Buchanan, Goldsmith, Campbell, & Stitt, 1988; Dunbar, Robertsson, Ryd, & Lindgren, 2001; McConnell, Kolopack, & Davis, 2001) and has also been reported to be responsive and valid in studies of both TKA patients (Lingard, Katz, Wright, Wright, Sledge, & The Kinemax Outcomes Group, 2001) and patients undergoing lower |
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| extremity rehabilitation programs (Angst, Aeschlimann, Steiner, & Stucki, 2001). Furthermore, the WOMAC score has been recommended to be used to evaluate joint pain and function in total knee replacement pa- tient populations by the National Institutes of Health (NIH Consensus Development Conference on Total Knee Replacement, 2003). In addition to completing the outcome questionnaire, passive knee flexion was mea- sured at the two study visits using standard goniometry. STATISTICAL ANALYSES Separate 2 2 mixed-model analysis of variances (group time) were used to assess differences in knee ROM and WOMAC scores. In addition, Fisher’s exact test was used to determine whether the groups differed in the number of patients who were able to achieve 110° or more of passive knee flexion. Knee ROM of 110° or more has been previously defi ned as the functional ROM necessary to allow patients to perform common activities of daily living such as navigating stairs, rising up from a low chair or commode, or tying one’s shoes (Branch et al., 2003; Rowe, Myles, Walker, & Nutton, 2000). Pearson’s product-moment correlation coeffi - cients were calculated to determine the relationship be- tween knee ROM and WOMAC scores. All analyses were performed using Statistics version 17.0 (SPSS, Inc., Chicago, IL), with p .05 being considered statistically signifi cant. Results Ten patients were randomized to the HIS group, and 10 patients were randomized to the LIS group. One patient with osteoarthritis of the hand who had been randomized to the LIS group was unable to use the device because of the inability to apply force with the device’s hand crank. That patient was then reassigned to the HIS group, result- ing in 11 patients being treated with the HIS device and nine being treated with the LIS device. The two groups did not differ in age, sex, body mass index, or pretreatment ROM or WOMAC scores (see Table 1). On average, pa- tients in the HIS group used the devices 6.9 weeks, which did not statistically differ from the 7.1 weeks of use for the LIS group (p .97). No patients in either group suffered any complications as a result of using home mechanical | therapy in the treatment of severe knee Arthrofibrosis. No patients developed wound problems or pressure sores as a result of using either of the devices, and no patients suf- fered any other unforeseen adverse events, such as a fall, during the study period. All patients demonstrated signifi cant improvement between the baseline and most recent follow-up in both knee ROM and WOMAC scores. In addition, signifi cant Group Time interactions were noted for both ROM and WOMAC scores, demonstrating that the HIS group demonstrated significantly greater gains in both ROM and WOMAC scores (see Figures 4 and 5). Patients in the HIS group demonstrated significantly greater gains in motion (pre 81.6° 7.6°, post 111.5° 6.7°, change 29.9°) than those in the LIS group (pre 84.9° 6.3°, post 101.9° 6.2°, change 17.0°, p .001). Furthermore, 91% (10/11) of the HIS group pa- tients demonstrated knee flexion of 110° or more at their most recent follow-up compared with only 22% (2/9) of the LIS group (p .001). The HIS group demonstrated significantly greater gains in WOMAC scores (pre 54.1, post 79.7, change 25.6) than the LIS group (pre 60.6, post 73.0, change 12.4, p .048), and posttreatment knee ROM significantly correlated with posttreatment WOMAC scores (r .53, p .02). Discussion The purpose of this randomized clinical trial was to compare the effi cacy of HIS and LIS home mechanical therapy in a sample of TKA patients with severe postop- erative Arthrofibrosis. In this randomized study of TKA patients with postoperative Arthrofibrosis, HIS home mechanical therapy resulted in significantly improved knee ROM and knee-related outcome scores. Furthermore, 91% of patients in the HIS group were able to achieve a functional ROM of 110° or more com- pared with 22% in the LIS group (p .001). Increased |
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| ROM significantly correlated with increased outcome scores, likely because patients were better able to per- form activities of daily living, such as navigating stairs, rising up from a low chair or commode, and tying one’s shoes. As motion increases, so does a person’s ability to perform activities of daily living without pain. Treatment with the HIS device may not only increase ROM and the ability to perform activities of daily living, but this high-intensity treatment has also been reported to reduce the risk of manipulation under anesthesia and/or more invasive motion-restoring surgeries. In a series of 34 patients with a mean follow-up of 4.7 years, Branch et al. (2003) reported that patients treated with the same device utilized in this study demonstrated sig- nifi cant gains in knee ROM and a reduced need for ma- nipulation under anesthesia. Furthermore, in the larg- est comparative study ever performed on Arthrofibrosis, patients treated with the same HIS device utilized in this study demonstrated significantly reduced rates of rehospitalization when compared with patients treated with an LIS device (Stephenson et al., 2010). The re- duced need for rehospitalization was associated with a signifi cant reduction in knee-related medical costs, with mean differences in posttreatment knee-related medical costs of approximately $8,500 (Stephenson et al., 2010). This study was not without limitation. The sample size was lower than what was initially indicated by the a priori power analysis. However, mean differences were similar to the predicted values that, combined with dramatically re- duced pooled standard deviations, allowed for fair and ac- curate analyses. The multicenter nature of this randomized study also introduced the potential for reduced interrater reliability of ROM measurements as multiple researchers were responsible for taking these measurements. In addi- tion, the examiners were not blinded to each patient’s group assignment, which is a limitation of this study. Also, while patients in both groups were instructed to use the | devices per the manufacturer’s recommended treatment protocols, we cannot verify that all patients were compliant during the entire course of the study. Patients were con- tacted weekly by phone and were asked to self-report both the number of stretching sessions performed per day and the duration of each session in minutes. Of the 20 study patients, only 12 routinely responded to the routine phone calls. Of the fi ve patients in the HIS group that responded to the phone calls, average weekly use of the device was 5.9 hr. In the LIS group, the seven respondents reported average weekly device use of 7.2 hr. These calls provided some information about daily use and compliance for these specific patients, but we cannot defi nitively state that all patients complied with the protocol. Finally, as the ma- jority of patients were enrolled in the physical therapy set- ting, information specific to the TKA surgical techniques and implant designs could not be attained. In conclusion, TKA patients with postoperative ar- throfi brosis in the current study treated with the HIS home mechanical therapy devices demonstrated signifi - cantly greater improvements in passive knee flexion and outcome scores when compared with patients treated with an LIS device. Future studies are warranted to de- termine whether these results can be generalized to a larger patient population, including patients being treated for different diagnoses or those who have under- gone other surgical procedures. 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