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The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted
Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.
PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected size. A standard error within 10° is accepted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| modified anteversion angle placement (( α-15°)±10°) of the acetabular component | Experimental | α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted |
|
| conventional anteversion angle placement ( α±10°) of the acetabular component | Placebo Comparator | α refers to the anatomical preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified anteversion angle placement(( α-15°)±10°) | Behavioral | Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis pre- designed anteversion angle is assembled for reconstruction after tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does. |
| Measure | Description | Time Frame |
|---|---|---|
| The endpoint for patient participation will dislocate | postoperative hip dislocation | followed for 1 years postoperatively for study end points |
| Measure | Description | Time Frame |
|---|---|---|
| MSTS score | The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research | followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints |
| TESS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Qu, MD | Contact | 13666615399 | email@zju.edu.cn | |
| Nong Lin, MD | Contact | 13958195545 | ldoctor@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo No.6 Hospital | Recruiting | Ningbo | Zhejiang | 311200 | China |
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| conventional anteversion angle placement ( α±10°) | Behavioral | Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis with predesigned anteversion angle is assembled for reconstruction following tumor resection. Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does. |
|
Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours |
| followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints |
| Henderson's failure mode | 1: soft tissue failure; 2: aseptic loosening; 3: structural failure; 4: periprosthetic infection; 5: tumor progression | followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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