Evaluation of bone remodeling in THA with Trabecular Metal Primary Hip Prosthesis

UMIN ID: UMIN000008991

Registered date:01/10/2012

Basic Information

• Recruitment status: Complete: follow-up continuing
• Health condition(s) or Problem(s) studied: secondary coxarthrosis with developmental dysplasia of the hip (DDH)
• Date of first enrollment: 2012/10/20
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

THA with Trabecular Metal™ Primary Hip Prosthesis
THA with VerSys HA-TCP Fiber Metal Taper Stem

Outcome(s)

• Primary Outcome: Bone mineral density (BMD) assessments: BMD around stem with Gruen classification and around cup with 4 ROIs will be measured within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. The change of BMD from immediately post-operation will be calculated at each visit.
• Secondary Outcome: Clinical Assessment: JOA Score will be evaluated at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively. Radiographic Assessment: X-ray will be taken before operation, within 1 week after operation, at the time of discharge, 12, 24, 52 and 104 weeks postoperatively. Evaluation of stress shielding, spot welds or others will be performed around stem with Gruen classification and around cup with DeLee & Charenly classification. If there is a gap between shell covered with Trabecular Metal™ and acetabulum, the time will be investigated until the gap is completely filled with bone. Questionnaire: Health status will be investigated with EQ-5D at the time of pre-operation, discharge, 12, 24, 52 and 104 weeks postoperatively. Safety Evaluation: When an adverse event or a product failure for which a causal relationship to the investigational or comparative device cannot be ruled out occurs, principal investigator or sub-investigator should report the event or the failure in accordance with the procedure outlined in section 14 of the protocol.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1) Patient who is skeletally immature 2) Patient with loss of abductor musculature in the affected limb 3) Patient with poor bone stock (e.g., steroid-induced metabolic bone disease) 4) Patient with poor skin coverage around the hip joint 5) Patient with neuromuscular disease (e.g., Charcot's joint) in the affected limb 6) Patient with infection symptoms (e.g., osteomyelitis in proximal femur, pyrogenetic infection of the hip) 7) Patient with stove pipe Dorr type C femur 8) Patient with osteoradionecrosis of the acetabulum 9) Patient with systematic or local infection 10) Patient with vascular deficiency in the affected limb that may lead to inadequate skeletal fixation 11) Patient who is not able to independently walk before THA 12) Patient who is suspected to have metal allergy 13) Patient who is pregnant, suspected pregnancy or planned to get pregnant during the study period 14) Patient with any comorbidity (e.g. dementia, schizophrenia, depression, panic disorder, generalized anxiety disorder, etc.) which may affect the ability of informed consent or completion of assessments 15) Patient who have planned to undergo THA, TKA, osteotomy or any operation of lower extremities within 6 months after enrollment 16) Patient who underwent THA, TKA, osteotomy or any operation of lower extremities less than 6 months before enrollment 17) Patient having other medical condition who is considered to be inappropriate by the investigator to participate in the study

Related Information

• Primary Sponsor: Zimmer K.K.
• Source(s) of Monetary Support: Zimmer K.K.