Pelvic defects
Conditions
Interventions
3d titanium printed pelvic implant
Sponsors
none
Eligibility
Inclusion criteria
Inclusion criteria: • Patients eligible to be treated with a 3DPI for: o Pelvic tumour resection o Failed total hip arthroplasty with Paprosky type 2C, 3A and 3B defects o Severe acetabular bone loss due to other reasons with Paprosky type 2C, 3A and 3B defects • Patients aged 18 years and older • Patient is able and willing to consent and participate in the study by signing and dating and IRB-approved consent form • Patient is willing to attend the follow-up evaluations at the LUMC (these evaluations will take place during regular clinical follow-up moments), for a minimum of two years post-operatively.
Exclusion criteria
Exclusion criteria: Primary exclusion criteria: • Patients who are unable or unwilling to cooperate in routine follow-up program • Patients who are mentally or cognitively disturbed • No written and signed Informed Consent • Active local or systemic infection • Insufficient Dutch language proficiency Secondary exclusion criteria: • Insufficient or poorly distributed RSA markers visible on baseline RSA radiographs which does not improve after repositioning the patient (2 attempts): the patient will be excluded from the RSA study, but patients will have regular clinical follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is migration assessment of the 3DPI implant, measured with model-based RSA. Migration is defined as movement (mm / degrees) of the component along and about the three orthogonal axes (x-, y- and z-axes) for translation and rotation. Migration patterns are obtained/calculated at 2 years (short-term), 5 and 10 years (mid-term) and 20 years (long-term). | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical parameters • Patients demographics: age, gender, weight, length, BMI, indication for surgery, Charnley score, pelvic/hip medical history; previous surgery. • Hip range of motion will be recorded during routine pre- and postoperative follow-up and noted according to common ROM examination: Flexion/Extension, Abduction/Adduction, Internal rotation/External rotation. • If 3DPI for tumour; tumour and oncological related characteristics: Enneking tumour stage, tumour histology, tumour resection margins, (neo) adjuvant therapy, local recurrences, metastatic status pre and post-operatively, patient survival. • Surgical data: Type/location of pelvic resection (according to Enneking pelvic resection classification), surgery date, surgical time, blood loss, transfusion requirements. • Implant specifics: details and type of 3DPI (as described in paragraph 7.1), if applicable: type, make and fixation of used acetabular shell and femoral stem (including bearing materials and head size). • Complications o Implant specific complications / (serious) adverse events and patient survival will be recorded according to appearance, severity and management. o For tumour related cases, the Henderson complication classification (53) will be used. • 3DPI Revision/mechanical failure; type of revision (total, partial), date, reason for revision. o A 3DPI revision/mechanical failure will be classified as any operative amendment to the implant, replacement of screws, change of any arthroplasty component or removal/exchange due to (a)septic loosening of the implant. Radiological parameters Based on pre-operative x-ray and CT scan: • For THA revision cases: Paprosky acetabular defect classification score (41) Based on post-operative x-rays: • 3DPI implant status: intact screws, signs of loosening based on gross implant migration, acetabular/femoral periprosthetic osteolysis according to the DeLee and Charnley zones (54). PROMS | — |
Contacts
Public ContactDemien Broekhuis
LUMC
Outcome results
None listed