Surgical Approach in Fast Track Knee Arthroplasty
Condition: Knee Arthroplasty, Total
Study type: Interventional

Summary: 
      Nowadays, due to the demands to improve life and health conditions of osteoarthritis
      patients, more effective surgical treatment methods are needed to obtain satisfactory results
      when performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence
      based multidisciplinary approaches targeted on multimodal patient care and primarily focused
      on enhancing rapid functional recovery of the patients. These protocols recommend use of
      minimal invasive approaches for TKA patients to enhance rapid recovery. Although studies in
      the literature has been reported similar results in medial para-patellar approach (MPP) and
      minimal invasive approaches in long terms, better surgical outcomes in short term in favor of
      minimal invasive approaches also encouraged fast-track protocol builders to prefer minimal
      invasive approaches. However, this recommendation is not evidence based and there is no study
      comparing surgical outcomes between minimal invasive approaches and MPP approach in terms of
      pain, length of hospital stays and functional recovery in fast-track TKA patients. Therefore,
      we aimed to compare the effects of mini mid-vastus (MMV) and MPP approaches on postoperative
      clinical results (pain, quality of life, functional outcome, and length of hospital stay) in
      fast-track TKA patients, and to decide whether any additional achievements are obtained with
      MMV approach in this patient group.
    

Detailed description: 
      Nowadays, due to the demands to improve life and health conditions of OA patients, more
      effective surgical treatment methods are needed to obtain satisfactory results when
      performing total knee arthroplasty (TKA). Fast-track surgical protocols are evidence based
      multidisciplinary approaches targeted on multimodal patient care and primarily focused on
      enhancing rapid functional recovery of the 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, and eventually hospital costs while obtaining maximum patient
      satisfaction.

      Surgical approaches when performing TKA operations includes standard medial parapatellar
      (MPP) approach and minimal invasive approaches such as mini midvastus (MMV) and subvastus
      (SV) approaches. 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 ROM) convinced surgeons to prefer minimal invasive approaches to MPP
      approach when performing rapid recovery protocols in TKA patients. In addition, better
      surgical outcomes with traditional protocols in short term reports in favor of minimal
      invasive approaches also encouraged fast-track protocol builders to prefer minimal invasive
      approaches. 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, length of hospital stay and functional recovery in fast-track TKA
      patients. Therefore, we aimed to compare the effects of MMV and MPP approaches on
      postoperative clinical results (pain, quality of life, functional outcome, and length of
      hospital stay) in fast-track TKA patients, and to decide whether any additional achievements
      are obtained with MMV approach in this patient group. Our secondary outcome measures were
      length of operation time, blood loss and postoperative component alignments.

      Clinical and demographic variables of the participants were recorded and patients were
      evaluated preoperatively, at postoperative fourth and twelfth week by a blinded observer.
      Knee range of motion was assessed with digital goniometer (HALO Medical Devices, Australia);
      quadriceps muscle strength was measured (unit=newton(N)) with hand-held dynamometer
      (Commander Muscle Tester, J Tech, USA); The Western Ontario and McMaster Universities
      Arthritis Index (WOMAC) and Knee injury and Osteoarthritis Outcome Score (KOOS) was used to
      determine patient-reported activity limitations; 30-sec 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.

      Alignment analysis Long leg radiographs of the patients were evaluated preoperatively and
      postoperatively by using a digital orthopedic templating software-Materialise OrthoView
      (OrthoView version 7, Materialise HQ, Technologielaan 15 3001 Leuven, Belgium).
      Hip-knee-ankle angles (HKA), femorotibial angles, lateral proximal femoral angles (LPFA),
      lateral distal femoral angles (LDFA), medial proximal tibial angles (MPTA), lateral distal
      tibial angles (LDTA), tibial posterior slope angles were all measured and recorded by a
      blinded observer.

      Preoperative patient education classes All the patients were received preoperative
      informative classes about TKA procedure, nutritional and nursing support, physical therapy
      and rehabilitation applications. Booklets concerning all these classes were also handed out
      to all patients.

      Anesthesia Protocol Excluding diabetics, all the patients were received oral carbohydrate
      (%12.5 carbohydrate liquid solution-Fantomalt, Nutricia) loading on the night before the
      operation (between 19:00 and 23:00) and 2 hours before the operation. Solid foods were
      allowed up to 6 hours before the operation and liquids allowed up to 2 hours preoperatively.
      Early oral feeding was started at 4 to 6 hours postoperatively 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 lumber fusion and 5 patients due to personal preference were received general
      anesthesia.

      Surgical Technique All the 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.
      All the patients received posterior stabilized fixed bearing TKA (NexGen Legacy® Posterior
      Stabilized Knee-Fixed Bearing, Zimmer-Biomet Inc., Warsaw, Indiana 46580, ABD), and high
      viscosity polymethyl methacrylate (PMMA) bone cement (Oliga-G21 srl-Vias. Pertini, 8-41039
      San Posidonia (MO)-Italy). All the operations were performed without using tourniquet.

      Local infiltration anesthesia (LIA) (20 cc bupivacaine hydrochloride, 1 gr fentanyl, 1 gr
      cefazolin sodium, 0.3 ml epinephrine, and dilute volume of physiologic serum (%0,9 NaCl) to
      50 cc) to posterior capsule just before the application of permanent implants, and to
      anterior capsule, prepatellar fat pad and peri ligamentous nociceptive receptors following
      consolidation of bone cement was injected.

      One gram of tranexamic acid was injected intravenously (iv) at least 30 minutes before the
      incision, 1 gr diluted to 30 cc by physiologic serum (%0,9 NaCl) was given intraarticularly
      following the closure of the wound, and another 1 gr was infused 2 hours after the operation.

      Preoperative and postoperative analgesia protocol For preemptive analgesia, paracetamol 500
      mg tablets were prescribed 3 times 2 tablets per day beginning from 3 days before the
      operation. One gram of iv infusion of paracetamol was given just after the operation in
      postoperative care unit and continued as 3 times 1gr iv infusion. First line rescue analgesic
      was intramuscular 75 mg diclofenac sodium and second line analgesic was iv 100 mg tramadol
      hydrochloride.

      Antibiotic and thrombosis prophylaxis protocol One gr of cefazolin sodium iv was applied 30
      minutes before the incision as antibiotic prophylaxis. Low molecular weight
      heparin-enoxaparin sodium 4000 iu/0.8 ml/day was used subcutaneously as thromboembolic
      prophylaxis starting at the 6-8 hours postoperatively and continued for 20 days.

      Rehabilitation protocol and discharge criteria The patients were mobilized at the 4th hour
      following surgery and standard physiotherapy program was scheduled during hospitalization
      (cold-pack -once 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/3 sets×10 repeats). The patients were evaluated regularly every two hours during
      postoperative period and those fulfilling discharge criteria were released from the hospital
      and length of hospital stay was recorded for every patient. The standard discharge criteria
      were as follows: VAS score at rest <3, VAS score during mobilization <5, able to get dressed
      independently, able to get in and out of bed, able to sit and rise from a chair/toilet seat,
      independence in personal care, mobilization with walker/crutches, able to walk >70 meters
      without risk of fall with walking aid, no incision problem.

      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 8 weeks. 15-40 minutes of walking exercises were also prescribed for 5
      days/week between 9th and 12th weeks.

      Statistical analysis Priori power analysis concerning quadriceps muscle strength 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 data was analyzed using SPSS 24.0 (IBM Corp. Released 2016. IBM SPSS Statistics for
      Windows, Version 24.0. Armonk, NY: IBM Corp.) package program. 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 normal 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 ANOVA was
      used to compare the normally distributed data from the parameters repeatedly measured in the
      inner-group analysis, and Friedman analysis of variance was performed for the remaining data
      set. Statistical significance was set at p ≤ 0.05.
    

Intervention name(s): Total knee arthroplasty
Intervention type(s): Procedure
Intervention description(s): Total knee arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients planned for fast track protocol applied total knee arthroplasty randomized into two groups by a computer program to generate random numbers and assign participants to either to mini mid-vastus or medial para-patellar surgical approach group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee arthroplasty; Surgical approach; Fast track