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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Total Hip Replacement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DELTA TT

Group Type EXPERIMENTAL

Delta TT acetabular cup

Intervention Type DEVICE

Interventions

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Delta TT acetabular cup

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No