A DEXA Clinical Study to Evaluate the Osteointegrative Potential of Trabecular Titanium™

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02635581

Enrollment

Registered

2015-12-21

Start date

2008-12-31

Completion date

2015-12-31

Last updated

2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Total Hip Replacement

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.

Interventions

DEVICEDelta TT acetabular cup

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan	From baseline to 5 year Follow-up

Secondary

Measure	Time frame
Harris Hip Score (HHS)	From baseline to 5 year Follow-up
SF-36 score	From baseline to 5 year Follow-up

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026