Methods
tumor, allergic, femoroacetabular impingement, synovitis, radiculopathy, intra-articular hip disorders, TCTR, infection, FAI, pain, hip flexion, neurological deficits, osteolytic, vasovagal
TUMOR, FEMOROACETABULAR IMPINGEMENT, SYNOVITIS, OSTEOARTHRITIS, DEGENERATIVE, RADICULOPATHY, RECRUITMENT, INFECTION, SECONDARY, STERILE, COMPLICATION, PATHOLOGY, COMPLICATIONS
The patient recruitment was performed at Thammasat University Hospital in January 2020 after approval by the ethics committee. All procedures performed in studies involving human participants were approved by the ethics committee of Thammasat University (Registration no. MTU-EC-OT-1-184/62) on 20/01/2020. The study protocol was registered and submitted to the Thai Clinical Trials Registry (TCTR) with the TCTR identification number TCTR20200722002. The date of the first registration was 22/07/2020. All methods were performed in accordance with the relevant guidelines and regulations.A prospective randomized controlled trial of hip intra-articular injection was started from 01/08/2020 to 31/03/2022 after the protocol had been registered and approved in the clinical trial registry. The inclusion criteria included patients with intra-articular hip disorders from osteoarthritis, femoroacetabular impingement (FAI), synovitis, and labral lesions who indicated an intra-articular steroid injection. The exclusion criteria included significant degenerative spine pathology with radiculopathy or significant neurological deficits, previous hip surgery of the injection side, presence of an osteolytic or osteoblastic lesion on imaging suspected tumor or infection origins, active infection around the hip, allergic to steroid or contrast media, and body mass index (BMI) more than 35 kg/mThe term “efficacy” in this study was primarily defined as the success of “one attempt of fluoroscopy-guided injection”. The secondary outcomes of efficacy included pain during injection, radiation doses and time, complications, and short-term functional score improvement using the modified Harris hip score (mHHS)From the pilot study, the resulting efficacy defined by “single attempt of injection” for the anterior, anterolateral, and proximal anterolateral approaches in 30 patients were 70%, 70%, and 90% respectively. Based on a non-inferiority trail with a 10% non-inferiority limit, the significance level (alpha) was 0.05, and the power was 90%. The output of the sample size calculation from n4Studies was 29 samples per group, with a total of 87 patients.After patient screening and recruitment by eligible criteria, all patients were advised of the procedures, risks, and benefits of the research, thereafter the patients were informed and signed the consent form. The pre-injection mHHS was evaluated on recruitment day. On the injection day, patients stayed in a supine position and put the pillow underneath the patient’s knees to provide about 20 degrees of hip flexion. The injection site was prepared in a standard sterile fashion. The approach of injection was random using computerized randomization with the block of 6 and allocated with a sealed opaqued envelope before injection. The injection was performed by a single fellowship-trained surgeon in hip arthroscopy under fluoroscopic guidance to enhance visual clarity, in the operation room without the pre-medication. The surface landmark of each injection approach on the right hip is shown in Fig. Demonstrated the surface landmark of each injection approach on the right hip. The first line was drawn from ASIS down to the center of the patella (line 1), the second line was drawn from the superior edge of the greater trochanter (GT) to intersect with line 1 perpendicularly (line 2), and the third line was drawn from the anterosuperior iliac spine (ASIS) directed inferolateral to the tip of GT (line 3). The entry point for the anterior approach (A) is the intersection between lines 1 and 2 (blue X mark). The entry point for the anterolateral approach (AL) is about 1 centimeter superior and anterior to the tip of GT (green X mark). The entry point for the proximal anterolateral approach (PAL) is about 1/3 upper portion of line 3 (red X mark).The intra-articular injection was performed using needle No.25, and a local anesthetic solution of 1% xylocaine without adrenaline 3 mL was injected. The Visual analog scale (VAS) during local anesthetic injection was evaluated. Then, using spinal needle No. 20 (Length of 90 mm) to inject the hip joint following protocol for each approach, the mixture of “Triamcinolone acetonide (40 mg) 1 mL plus an OmniplaqueTM (350mg/mL) 1 mL plus the 1% Xylocaine without adrenaline 8 mL” were injected into the hip joint. Fluoroscopic imaging (PHILIPS BV Pulsera) was used in the anteroposterior (AP) view to identify whether the approach was successful. “Success” is defined by the contrast media filled inside the hip capsule.“Single attempt” was defined as the single shot in injection without redirection of the spinal needle (redirection was defined by changing the direction by pulling back the needle more than half of the needle length). “More than one attempt or multiple attempts” was defined as the need for redirection by pulling a spinal needle out for more than 40 mm (half of the needle length). VAS during intra-articular hip injection was recorded.Radiation exposure was recorded as doses and radiation time. Complication such as infection or vasovagal symptoms was recorded (if occurred). The patients were made appointments for subsequence follow-ups at 2 weeks intervals and were evaluated for post-injection mHHS.