A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™
1 other identifier
interventional
84
1 country
4
Brief Summary
The purpose of this clinical trial is to evaluate the osteointegrative potential of the Trabecular TitaniumTM and to measure the pattern of changing in bone mineral density (BMD) around an uncemented acetabular cup, manufactured in Trabecular Titanium™ , during 60 months after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2008
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
December 15, 2015
CompletedFirst Posted
Study publicly available on registry
December 21, 2015
CompletedMarch 2, 2016
March 1, 2016
7 years
December 15, 2015
March 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan
From baseline to 5 year Follow-up
Secondary Outcomes (2)
Harris Hip Score (HHS)
From baseline to 5 year Follow-up
SF-36 score
From baseline to 5 year Follow-up
Study Arms (1)
DELTA TT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- BMI\< 40 kg/m2
- Indication suitable to the implantation of Delta TT acetabular cup (First implant)
- Idiopathic osteoarthritis
- Avascular necrosis
- Post-traumatic arthritis
- Presence of sufficient periacetabular bone stock
- Ability to understand the investigation, cooperate with the investigational procedure and willing to return to the hospital for the required post-operative follow-ups
- Written informed consent
You may not qualify if:
- Patients found unsuitable for an implantation of Delta TT acetabular cup (Revision)
- Patients aged 76 or older
- Haemophilic disease
- Femur neck fracture
- Insulin Dependent Diabetes Mellitus (IDDM)
- Severe kidney failure (grade 4)
- Not responder Hypo- or Hyperthyroidism
- Paget's disease
- Tumours
- Active or suspicious infections
- Neurosensory deficits or neuromuscular diseases
- Severe and impairing vascular diseases
- Known incompatibility or allergy to products materials
- Woman with pregnancy or childbearing capacity or breast-feeding
- Subjects already enrolled in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
Cona, Ferrara, 44124, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica II
Torino, 10126, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica I
Torino, 10126, Italy
Azienda Ospedaliero-Universitaria di Udine, Santa Maria della Misericordia
Udine, 33100, Italy
Study Officials
- PRINCIPAL INVESTIGATOR
Leo Massari
Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2015
First Posted
December 21, 2015
Study Start
December 1, 2008
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 2, 2016
Record last verified: 2016-03