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

Limacorporate

Status

Completed

Conditions

Primary Total Hip Replacement

Treatments

Device: Delta TT acetabular cup

Study type

Interventional

Funder types

Industry

Identifiers

NCT02635581

TT-01

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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