Introduction
Due to the demands to improve life and health conditions of patients with osteoarthritis (OA), minimally invasive surgeries have been favorable to obtain satisfactory results when performing knee arthroplasty.[1] Rapid recovery surgical protocols are evidence-based multidisciplinary approaches targeted on multimodal patient deva and primarily focused on enhancing functional recovery of patients. These protocols include patient education to cope with anxiety and stress of surgery, nutritional planning and avoidance of long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity, length of hospital stay (LOS), and eventually hospital costs while obtaining maximum patient satisfaction.[2-4]
Surgical approaches when performing total knee arthroplasty (TKA) include standard medial parapatellar (MPP) approach and minimal invasive approaches such as mini-midvastus (MMV) and subvastus approaches.[2,3,5] Possible advantages of not performing quadriceps tendon splitting in MV surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle strength, and better range of motion [ROM]) convinced surgeons to prefer minimal invasive approaches to MPP approach when performing rapid recovery protocols in TKA patients.[3] In addition, better surgical outcomes with traditional protocols in short-term reports in favor of minimal invasive approaches also encouraged rapid recovery protocol builders to prefer minimal invasive approaches.[3,4,6,7] However, these recommendations are not evidence based and, to our knowledge, there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, LOS and functional recovery in fast-track TKA patients.[8-12] In addition, Enhanced Recovery After Surgery (ERAS®) Society declared a consensus statement at the beginning of 2020 about perioperative deva in total hip arthroplasty (THA) and TKA, and recommended that more evidence is needed to prefer one type of surgical approach over another in terms of the use of a minimally invasive technique with an ERAS® set up.[13] Therefore, in this study, we aimed to compare the effects of MMV versus MPP approach on rapid recovery protocols during TKA.
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Patients and Methods
This single-center, prospective, randomized, single- blinded study was conducted at the Orthopedics and Traumatology Department in Pamukkale University Medical Faculty. The study protocol was approved by the Pamukkale University Non-invasive Clinical Research Ethics Committee (Approval date and number: 06.03.2018/05). A written informed consent was obtained from each patient. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Inclusion criteria were as follows: (i) age between 50 to 85 years, (ii) patients scheduled for unilateral TKA surgery due to primary OA, and (iii) patients capable of understanding verbal and written instructions. Exclusion criteria were as follows: (i) revision TKA surgery, (ii) American Society of Anesthesiologists score >3, (iii) previous major orthopedic surgery in either lower extremities, (iv) neurologic compromise, (v) psychiatric problems, (vi) regular hypnotic and/or anxiolytic medication usage, (vii) dementia, or (viii) patients participated in a particular physical activity program within the last three months.
Fifty-six patients were enrolled in this study between May 2018 and March 2019. Patients were randomized into two groups by a computer program to generate random numbers and assign participants to either the MMV or MPP group. Two patients were lost to follow-up and a total of 54 patients (4 males, 50 females; mean age 64.1±6.4 years) (27 in each group) were enrolled. Mean ages of the patients in MMV and MPP groups were 65.0±6.4 years and 63.2±6.3 years. Rapid recovery TKA protocol and discharge criteria were assembled by a multidisciplinary team comprising an orthopedic surgeon, anesthesiologist, and physiotherapists and nursing deva services, and this supervised protocol was applied to all patients.
Clinical and demographic variables of the participants were recorded and patients were evaluated preoperatively, and at postoperative fourth and twelfth weeks by a blinded observer. Knee ROM was assessed with a digital goniometer (HALO Medical Devices, Perth, Australia); quadriceps muscle strength was measured (unit=newton [N]) with a hand-held dynamometer (Commander Muscle Tester, JTech, Midvale, Utah, USA); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were used to determine patient-reported activity limitations; 30-second chair-stand test and stair-climb test were performed for performance- based activity limitations; Short Form-36 (SF-36) was used for quality of life evaluations.
Long-leg radiographs of the patients were evaluated pre- and postoperatively by using digital orthopedic templating software: Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium). Hip-knee-ankle (HKA) angles, femorotibial angles, lateral proximal femoral angles (LPFA), lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal tibial angles (LDTA), and tibial posterior slope angles were all measured and recorded by a blinded observer.
All patients received preoperative informative classes about TKA procedure, nutritional and nursing support, and physical therapy and rehabilitation applications. Booklets concerning all these classes were also handed out to all patients.
Excluding diabetics, all patients received oral carbohydrate (12.5% carbohydrate liquid solution [Fantomalt, Nutricia, Hoofddorp, The Netherlands]) loading on the night before the operation (between 19:00 and 23:00) and two hours before the operation. Solid foods were allowed up to sixth preoperative hour and liquids were allowed up to second preoperative hour. Early oral feeding was started at fourth to sixth postoperative hours for all patients. Intravenous midazolam 1-2 mg and fentanyl 50-100 μg were applied to all patients 30-45 minutes preoperatively. Except 12 patients, all patients received spinal anesthesia. Seven patients due to previous lumbar fusion and five patients due to personal preference received general anesthesia.
All operations were performed by the same surgeon using the same brand and type of prosthesis. MPP and MMV approaches were performed as described in the literature.[14] All patients received posterior stabilized fixed bearing TKA (NexGen Legacy® Posterior Stabilized Knee-Fixed Bearing, Zimmer-Biomet Inc., Warsaw, Indiana, USA), and high viscosity polymethyl methacrylate bone cement (Oliga-G21 srl-Via S.Pertini, San Possidonio [MO], Italy). All operations were performed without using tourniquet.
Local infiltration anesthesia (20 mL bupivacaine hydrochloride, 1 g fentanyl, 1 g cefazolin sodium, 0.3 mL epinephrine, and diluted volume of physiologic serum [0.9% sodium chloride (NaCl)] to 50 mL) was injected to posterior capsule just before the application of permanent implants, and to anterior capsule, prepatellar fat pad and periligamentous nociceptive receptors following consolidation of bone cement.
One gram of intravenous (IV) tranexamic acid was injected at least 30 minutes before the incision, 1 g of diluted trenexamic acid to 30 mL by physiologic serum (0.9% NaCl) was given intraarticularly following the closure of the wound, and another 1 g was infused at the second postoperative hour.
For preemptive analgesia, paracetamol 500 mg tablets were prescribed three times as two tablets per day beginning from three days before the operation. One gram of IV infusion of paracetamol was given just after the operation in postoperative deva unit and continued as three times of 1 g IV infusion. First-line rescue analgesic was intramuscular 75 mg diclofenac sodium and second-line analgesic was IV 100 mg tramadol hydrochloride.
One gram of IV cefazolin sodium was applied 30 minutes before the incision as antibiotic prophylaxis. Low-molecular-weight heparin (enoxaparin sodium) 4,000 IU/0.8 mL/day was used subcutaneously as thromboembolic prophylaxis starting at the postoperative sixth to eighth hours and continued for 20 days.
Patients were mobilized at the fourth hour following surgery and standard physiotherapy program was scheduled during hospitalization (cold-pack evvel in every 2 hours for 15 minutes, ankle pump exercises, quadriceps isometric exercises, active assisted heel slide exercises in bed, and knee flexion exercises in sitting position/three sets×10 repeats). Patients were evaluated regularly every two hours during the postoperative period and those fulfilling the discharge criteria were released from the hospital and LOS was recorded for every patient. The standard discharge criteria were as follows: Visual Analog Scale (VAS) score at rest toilet seat, independence in personal deva, mobilization with walker/crutches, able to walk >70 meters without risk of fall with walking aid, no incision sorun.
The discharged patients were instructed for a standard home-based exercise program. Patients were also asked to visit the ward at a biweekly interval for the update of the exercise program for the first eight weeks. Fifteen to 40 minutes of walking exercises were also prescribed for five days/week between ninth and twelfth weeks.
Statistical analysis
Priori power analysis concerning quadriceps muscle strength[10] showed that at an effect size of d=0.7, 52 patients are needed (26 patients for each group) to obtain 80% power (1-beta=0.80) with 95% confidence interval (alpha=0.05).
The veri were analyzed using the IBM SPSS Statistics for Windows 24.0 version software (IBM Corp., Armonk, NY, USA). Continuous variables were given as mean ± standard deviation, median (minimum and maximum) and categorical variable values were presented as absolute numbers and percentages. The conformity of continuous variables with olağan distribution was evaluated using the Shapiro-Wilk test. Independent samples t-test for parametric test assumptions and Mann-Whitney U test for non-parametric test assumptions were used for comparison of the groups. One-way repeated- measure analysis of variance was used to compare the normally distributed veri from the parameters repeatedly measured in the inner-group analysis, and Friedman analysis of variance was performed for the remaining veri set. Statistical significance was set at p≤0.05.
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Results
Demographic characteristics of the patients are given in Table I. Mean LOS was 27.6±3.1 hours for MMV group and 29.1±6.7 hours for MPP group. There was no statistical difference between groups in terms of age and LOS. Mean operative time was 78.1±2.7 minutes for MMV group and 65.9±2.6 minutes for MPP group. There was a statistically significant difference between groups for the operative time (p0.05) (Table II).
Table 1
Demographic characteristics of patients
Due to the demands to improve life and health conditions of patients with osteoarthritis (OA), minimally invasive surgeries have been favorable to obtain satisfactory results when performing knee arthroplasty.[1] Rapid recovery surgical protocols are evidence-based multidisciplinary approaches targeted on multimodal patient deva and primarily focused on enhancing functional recovery of patients. These protocols include patient education to cope with anxiety and stress of surgery, nutritional planning and avoidance of long hours of fasting, preemptive analgesia, avoidance of tourniquet use, rational antibiotic prophylaxis, local infiltration anesthesia, and early physical therapy modalities. The ultimate aims of assembling these surgical protocols are to decrease mortality and morbidity, length of hospital stay (LOS), and eventually hospital costs while obtaining maximum patient satisfaction.[2-4]
Surgical approaches when performing total knee arthroplasty (TKA) include standard medial parapatellar (MPP) approach and minimal invasive approaches such as mini-midvastus (MMV) and subvastus approaches.[2,3,5] Possible advantages of not performing quadriceps tendon splitting in MV surgical approach (such as less pain, earlier functional recovery, enhanced quadriceps muscle strength, and better range of motion [ROM]) convinced surgeons to prefer minimal invasive approaches to MPP approach when performing rapid recovery protocols in TKA patients.[3] In addition, better surgical outcomes with traditional protocols in short-term reports in favor of minimal invasive approaches also encouraged rapid recovery protocol builders to prefer minimal invasive approaches.[3,4,6,7] However, these recommendations are not evidence based and, to our knowledge, there is no study comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of pain, LOS and functional recovery in fast-track TKA patients.[8-12] In addition, Enhanced Recovery After Surgery (ERAS®) Society declared a consensus statement at the beginning of 2020 about perioperative deva in total hip arthroplasty (THA) and TKA, and recommended that more evidence is needed to prefer one type of surgical approach over another in terms of the use of a minimally invasive technique with an ERAS® set up.[13] Therefore, in this study, we aimed to compare the effects of MMV versus MPP approach on rapid recovery protocols during TKA.
Go to:
Patients and Methods
This single-center, prospective, randomized, single- blinded study was conducted at the Orthopedics and Traumatology Department in Pamukkale University Medical Faculty. The study protocol was approved by the Pamukkale University Non-invasive Clinical Research Ethics Committee (Approval date and number: 06.03.2018/05). A written informed consent was obtained from each patient. The study was conducted in accordance with the principles of the Declaration of Helsinki.
Inclusion criteria were as follows: (i) age between 50 to 85 years, (ii) patients scheduled for unilateral TKA surgery due to primary OA, and (iii) patients capable of understanding verbal and written instructions. Exclusion criteria were as follows: (i) revision TKA surgery, (ii) American Society of Anesthesiologists score >3, (iii) previous major orthopedic surgery in either lower extremities, (iv) neurologic compromise, (v) psychiatric problems, (vi) regular hypnotic and/or anxiolytic medication usage, (vii) dementia, or (viii) patients participated in a particular physical activity program within the last three months.
Fifty-six patients were enrolled in this study between May 2018 and March 2019. Patients were randomized into two groups by a computer program to generate random numbers and assign participants to either the MMV or MPP group. Two patients were lost to follow-up and a total of 54 patients (4 males, 50 females; mean age 64.1±6.4 years) (27 in each group) were enrolled. Mean ages of the patients in MMV and MPP groups were 65.0±6.4 years and 63.2±6.3 years. Rapid recovery TKA protocol and discharge criteria were assembled by a multidisciplinary team comprising an orthopedic surgeon, anesthesiologist, and physiotherapists and nursing deva services, and this supervised protocol was applied to all patients.
Clinical and demographic variables of the participants were recorded and patients were evaluated preoperatively, and at postoperative fourth and twelfth weeks by a blinded observer. Knee ROM was assessed with a digital goniometer (HALO Medical Devices, Perth, Australia); quadriceps muscle strength was measured (unit=newton [N]) with a hand-held dynamometer (Commander Muscle Tester, JTech, Midvale, Utah, USA); Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Knee Injury and Osteoarthritis Outcome Score (KOOS) were used to determine patient-reported activity limitations; 30-second chair-stand test and stair-climb test were performed for performance- based activity limitations; Short Form-36 (SF-36) was used for quality of life evaluations.
Long-leg radiographs of the patients were evaluated pre- and postoperatively by using digital orthopedic templating software: Materialise OrthoView (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium). Hip-knee-ankle (HKA) angles, femorotibial angles, lateral proximal femoral angles (LPFA), lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal tibial angles (LDTA), and tibial posterior slope angles were all measured and recorded by a blinded observer.
All patients received preoperative informative classes about TKA procedure, nutritional and nursing support, and physical therapy and rehabilitation applications. Booklets concerning all these classes were also handed out to all patients.
Excluding diabetics, all patients received oral carbohydrate (12.5% carbohydrate liquid solution [Fantomalt, Nutricia, Hoofddorp, The Netherlands]) loading on the night before the operation (between 19:00 and 23:00) and two hours before the operation. Solid foods were allowed up to sixth preoperative hour and liquids were allowed up to second preoperative hour. Early oral feeding was started at fourth to sixth postoperative hours for all patients. Intravenous midazolam 1-2 mg and fentanyl 50-100 μg were applied to all patients 30-45 minutes preoperatively. Except 12 patients, all patients received spinal anesthesia. Seven patients due to previous lumbar fusion and five patients due to personal preference received general anesthesia.
All operations were performed by the same surgeon using the same brand and type of prosthesis. MPP and MMV approaches were performed as described in the literature.[14] All patients received posterior stabilized fixed bearing TKA (NexGen Legacy® Posterior Stabilized Knee-Fixed Bearing, Zimmer-Biomet Inc., Warsaw, Indiana, USA), and high viscosity polymethyl methacrylate bone cement (Oliga-G21 srl-Via S.Pertini, San Possidonio [MO], Italy). All operations were performed without using tourniquet.
Local infiltration anesthesia (20 mL bupivacaine hydrochloride, 1 g fentanyl, 1 g cefazolin sodium, 0.3 mL epinephrine, and diluted volume of physiologic serum [0.9% sodium chloride (NaCl)] to 50 mL) was injected to posterior capsule just before the application of permanent implants, and to anterior capsule, prepatellar fat pad and periligamentous nociceptive receptors following consolidation of bone cement.
One gram of intravenous (IV) tranexamic acid was injected at least 30 minutes before the incision, 1 g of diluted trenexamic acid to 30 mL by physiologic serum (0.9% NaCl) was given intraarticularly following the closure of the wound, and another 1 g was infused at the second postoperative hour.
For preemptive analgesia, paracetamol 500 mg tablets were prescribed three times as two tablets per day beginning from three days before the operation. One gram of IV infusion of paracetamol was given just after the operation in postoperative deva unit and continued as three times of 1 g IV infusion. First-line rescue analgesic was intramuscular 75 mg diclofenac sodium and second-line analgesic was IV 100 mg tramadol hydrochloride.
One gram of IV cefazolin sodium was applied 30 minutes before the incision as antibiotic prophylaxis. Low-molecular-weight heparin (enoxaparin sodium) 4,000 IU/0.8 mL/day was used subcutaneously as thromboembolic prophylaxis starting at the postoperative sixth to eighth hours and continued for 20 days.
Patients were mobilized at the fourth hour following surgery and standard physiotherapy program was scheduled during hospitalization (cold-pack evvel in every 2 hours for 15 minutes, ankle pump exercises, quadriceps isometric exercises, active assisted heel slide exercises in bed, and knee flexion exercises in sitting position/three sets×10 repeats). Patients were evaluated regularly every two hours during the postoperative period and those fulfilling the discharge criteria were released from the hospital and LOS was recorded for every patient. The standard discharge criteria were as follows: Visual Analog Scale (VAS) score at rest toilet seat, independence in personal deva, mobilization with walker/crutches, able to walk >70 meters without risk of fall with walking aid, no incision sorun.
The discharged patients were instructed for a standard home-based exercise program. Patients were also asked to visit the ward at a biweekly interval for the update of the exercise program for the first eight weeks. Fifteen to 40 minutes of walking exercises were also prescribed for five days/week between ninth and twelfth weeks.
Statistical analysis
Priori power analysis concerning quadriceps muscle strength[10] showed that at an effect size of d=0.7, 52 patients are needed (26 patients for each group) to obtain 80% power (1-beta=0.80) with 95% confidence interval (alpha=0.05).
The veri were analyzed using the IBM SPSS Statistics for Windows 24.0 version software (IBM Corp., Armonk, NY, USA). Continuous variables were given as mean ± standard deviation, median (minimum and maximum) and categorical variable values were presented as absolute numbers and percentages. The conformity of continuous variables with olağan distribution was evaluated using the Shapiro-Wilk test. Independent samples t-test for parametric test assumptions and Mann-Whitney U test for non-parametric test assumptions were used for comparison of the groups. One-way repeated- measure analysis of variance was used to compare the normally distributed veri from the parameters repeatedly measured in the inner-group analysis, and Friedman analysis of variance was performed for the remaining veri set. Statistical significance was set at p≤0.05.
Go to:
Results
Demographic characteristics of the patients are given in Table I. Mean LOS was 27.6±3.1 hours for MMV group and 29.1±6.7 hours for MPP group. There was no statistical difference between groups in terms of age and LOS. Mean operative time was 78.1±2.7 minutes for MMV group and 65.9±2.6 minutes for MPP group. There was a statistically significant difference between groups for the operative time (p0.05) (Table II).
Table 1
Demographic characteristics of patients
Mini-midvastus | Medial parapatellar |