1.1 Inclusion and exclusion criteria
Inclusion criteria: 1) The patient had previously undergone tumor segmental resection and prosthesis replacement due to bone tumors in the distal femur, and the fixation method was bone cement fixation; 2) Revision surgery was performed due to aseptic loosening, and the prosthesis was fixed with bone cement; 3) The appearance of aseptic loosening was supported by clinical symptoms and imaging studies; 4) There are full-length anteroposterior X-rays of both lower limbs after revision surgery.
Exclusion criteria: 1) Existence of tumor recurrence, periprosthetic infection, structural failure (prosthetic fracture, periprosthetic fracture, polyethylene liner wear, and so on), soft tissue failure (joint dislocation, incision aseptic dehiscence, and so on.); 2) Full-length anteroposterior X-ray film of both lower limbs was not standard and could not be effectively measured; 3) The last operation was followed up on in less than a year.
1.2 Patients
A total of 23 patients who underwent revision surgery of distal femur prosthesis due to aseptic loosening from June 2002 to June 2021 in PLA's 960th Hospital were selected. The mean age of the patients was (44.39±12.41) years old, including 15 males and 8 females, with a male-to-female ratio of 1.875: 1. There were 13 cases of giant cell tumor of bone, 7 cases of osteosarcoma, 2 cases of malignant fibrous histiocytoma, and 1 case of chondrosarcoma. 7 patients underwent chemotherapy and 7 patients had leg unequal length (affected limb shortening > 3cm) before revision. At the end of the study, all 23 patients survived, including 1 patient who underwent knee arthrodesis 5 years after revision surgery due to aseptic loosening. 9 of the 23 patients had aseptic loosening after revision surgery and were, therefore, included in the loosening group. The remaining 14 patients in this study had no complications such as aseptic loosening by the end of the follow-up period and were classified as control group.
1.3 Prosthesis
All of the knee prostheses were tumor-type, with 15 customized prostheses (manufactured by Beijing Lidakang Company) and 8 combined prostheses (provided by Shandong Weigao Company). There were 2 fixed hinge knee prostheses and 21 rotary hinge knee prostheses. There were 2 curved stem cases and 21 straight stem cases. Bone cement was used to secure all prostheses.
1.4 Surgical methods
The patient was placed in a supine position after a successful general anesthesia, and the surgical area was routinely disinfected, draped, and covered with a protective film. The original surgical incision was made and extended to the proximal end of the femur. The skin, subcutaneous tissue and fascia layer were cut layer by layer, the scar tissue around the knee joint was cut, the joint capsule was cut medial to the patellar, the space between the vastus lateralis and the rectus femoris muscle was separated, the intermedius femoris muscle was split, and the femoral shaft and the artificial knee joint were exposed by pushing and stripping. It was discovered that formation of grayish yellow boundary membrane tissue around the prosthesis, obvious loosening of the femur end, abnormal activity, the presence of bone cement and cortical space, the formation of callus at the distal femur end, covering part of the stem. After the dislocation of the knee prosthesis, the femur end was lifted retrograde, the callus around the prosthesis was chiseled out, and the femoral bone marrow stem prosthesis was removed. The intramedullary boundary membrane tissue and residual bone cement were thoroughly removed with curettage, and the proximal end was expanded along the longitudinal axis of the femoral shaft to the position of the intertrochanteric fossa. After the tibia was treated, the tibia prosthesis was retrogradely punched out in the medial foramen of the tibia nodule and the bone cement in the tibia medullary cavity was further scraped. After the distal medullary cavity was expanded, the hydrogen hydroxide and normal saline were rinsed repeatedly, the medullary cavity and incision were rinsed with pulse pressure, and the bone cement was injected into the bone marrow cavity of the tibia and femur, new tibia prosthesis and femur prosthesis of appropriate length and thickness were inserted. Following the solidification of the bone cement, the knee prostheses were reset, the polyethylene meniscus pad was placed, and the flexion and extension mobile knee joints demonstrated good force lines and activities. After the hemostatic was completely removed, hydrogen peroxide and a large amount of normal saline were rinsed, patella was trimmed, the instruments and dressing were checked, two drainage tubes were placed, the surgical incision was closed layer by layer, and sterile dressing was bound and fixed.
1.5 Imaging evaluation
1. The length and diameter of the intramedullary stem of the prosthesis after the initial replacement.
2. Osteotomy length, femoral length, extramedullary length of femoral prosthesis, femoral prosthesis intramedullary stem length, intramedullary stem diameter, femoral diameter, HKAA, mLDFA, mLDFA, the deviation angle between the force line of the lower limb and the longitudinal axis of the femoral prosthesis, and the deviation angle between the force line of the lower limb and the longitudinal axis of the tibial prosthesis after the revision surgery.
1.6 Measurement method
The standard full-length anteroposterior X-ray of both lower limbs of the patient was measured using Picture Archiving and Communication System (PACS, Qingdao Medicom Digital Engineering Company) with built-in length and angle. During measurement, the femoral head center (concentric circle method), the knee joint center (the midpoint of the intercondylar fossa of the femur and the tibial crest), and the ankle joint center (the midpoint of the line between the surface of the medial and lateral malleolus through the articular surface of the distal tibia) were marked.
Statistical analysis
Statistical analysis was performed using SPSS 25.0 (IBM Corporation, USA) statistical software. Normally distributed measurement data were expressed as mean ± standard deviation ( ±S), and analyzed using the T test on two independent samples; non-normally distributed measurement data were analyzed using the Kruskal-Wallis multiple independent samples method. Fisher's chi-square test was used to analyze the count data.