This study data were collected from the Department of Orthopedics, the Third Affiliated Hospital of Kunming Medical University (Yunnan Provincial Cancer Hospital) from 2006 to 2016, and the patients received either "smear removal + intramedullary nail fixation + bone cement filling" or "tumor lesion resection + customized tumor artificial half-hip joint replacement." A propensity score-matched study in patients with proximal femoral metastases treated with hemiarthroplasty was carried out to explore the surgical treatment of metastatic carcinoma of the proximal femur, its clinical effect, and the prognostic analysis. The curative effects of intramedullary nail placement and arthroplasty for the treatment of metastatic carcinoma of the proximal femur were compared, and the factors that affected the survival rate of patients were analyzed retrospectively.
Data screening criteria
1 Inclusion criteria
(1) Clinical and imaging diagnoses of metastatic carcinoma of the proximal femur, with pain in the proximal femur as the main clinical manifestation;
(2) The Mirels score (see table below) was 9 or more points, or pathological fracture occurred;
(3) The expected survival time was >3 months;
(4) Fair general body condition; patients could tolerate the operation;
(5) The informed consent form was signed, and surgery was performed;
(6) All patients received routine chemotherapy and other comprehensive treatments according to the original scheme;
(7) Patients who could return to the hospital regularly after the operation for review, and patients who could be followed in a clinic or by telephone.
2 Exclusion criteria
(1) Primary bone tumors;
(2) The patient's general condition was poor, or there were serious systemic diseases so that the patients could not undergo anesthesia or surgery;
(3) Patients and their families refused surgical treatment;
(4) The postoperative treatment plan could not be completed according to the treatment plan;
(5) Rejected for objective reasons, patients who did not have complete clinical data or patients lost to follow-up.
Grouping and Surgical Methods
Patients were divided into two groups:
(1) Intramedullary nail fixation group (nailing group): the patients were treated with curettage + intramedullary nail fixation + bone cement filling.
(2) Joint replacement group: the patients were treated with tumor segment resection + customized tumor artificial hemiarthroplasty.
Research method
1 Preoperative examination
All patients required routine examination before the operation, including routine blood, urine, and stool examinations; liver and kidney function, electrolyte, and coagulation measurements; dynamic electrocardiogram; lung function tests; and DR, CT, MRI, and SPECT. PET-CT examination was utilized if permitted by the economic condition of the patient. If the patient had a history of hypertension or hyperglycemia, blood pressure and blood sugar were measured before the operation.
2 Preoperative and postoperative treatments
Antibiotics were injected intravenously 30 minutes before the surgery, and all the examination results, including routine blood, liver and kidney function, electrolytes, and infection indicators, were reviewed. Postoperatively, the affected limbs were elevated, and negative pressure drainage was continued. The antibiotics were continued for 5 to 7 days after the operation. When the color of the drainage fluid was pale and amounted to less than 30 ml for 3 consecutive days, the tube was removed. Patients were instructed to perform early limb functional exercises to prevent the adhesion of muscles and nerves, to strengthen the muscles of the lower limbs, and to avoid atrophy of the lower limb muscles.
3 Follow-up content and indicators for observation
3.1 Follow-up content
All the patients included in the study as well as their respective surgery times and intraoperative bleeding levels and whether they experienced postoperative hospital follow-up, follow-up by telephone or outpatient follow-up were recorded. The follow-up assessments included those of pain, limb function, quality of life, complications, and survival in the patients.
Table 1
The Revised Musculoskeletal Tumor Society Rating Scale
Score
|
Pain
|
Function
|
Emotional
|
Supports
|
Walking
|
Gait
|
5
|
No pain
|
No restriction
|
Enthused
|
None
|
Unlimited
|
Normal
|
4
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
3
|
Modest
|
Recreational restriction
|
Satisfied
|
Brace
|
Limited
|
Minor cosmetic
|
2
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
Intermediate
|
1
|
Moderate
|
Partial restriction
|
Accepts
|
One cane or crutch
|
Inside only
|
Major cosmetic
|
0
|
Severe disabling
|
Total restriction
|
Dislikes
|
Two canes or crutches
|
Not independent
|
Major handicap
|
3.2 Observation indicators
(1) VAS scores were used to assess pain before as well as 1, 3, 6 and 12 months after the operations, and the VAS score ranged from 0-10. The higher the VAS score of the patient was, the more severe the pain.16
(2) The MSTS score was used to test the functional status of an affected limb before and 1, 3, 6, and 12 months after the operations17 (Table 1).
(3) The ECOG score was used to test the quality of life of the patients before and 1, 3, 6 and 12 months after the operation (Table 2).
(4) The presence of intraoperative hemorrhage, operative time, postoperative complications and survival time were recorded.
Table 2
ECOG performance status
Grade
|
ECOG
|
0
|
Full active, able to carry on all pre-disease performance without restriction
|
1
|
Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work
|
2
|
Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of walking hours
|
3
|
Capable of only limited selfcare, confined to bed or chair more than 50% of walking hours
|
4
|
Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair
|
5
|
Dead
|
Statistical methods
The propensity matching score18 was used to create two comparable groups. The intramedullary nailing group was considered the "treatment group", and the hip replacement group was considered the "control group". The patient's sex and age, location of the metastases, presence or absence of pathological fractures, number of metastases, primary tumor type, primary surgery type, preoperative VAS score, preoperative ECOG score, and preoperative MSTS score were used for the logistic regression analysis of covariates to estimate propensity scores for each eligible case. The logistic regression procedure created a probability score for each subject. Then, he nearest neighbor was matched unsubstituted,19-21 the tolerance was matched to 0.03, and the score was manually matched.
Data analysis was performed using SPSS 24.0 software. The continuous data were reported as the mean ± standard deviation and were compared with t-tests; the classified data were expressed as the count and percentage and were compared with the chi-square test. P<0.05 was statistically significant. The Kaplan-Meier log-rank test was used to analyze the survival rate of patients with single-factor analysis. Cox regression multiple factor analysis was used to analyze the factors affecting the survival rate of patients with proximal femoral metastases.