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

Not Applicable

Completed

• Conditions: Primary Total Hip Replacement
• Interventions: Device: Delta TT acetabular cup

• Registration Number: NCT02635581
• Lead Sponsor: Limacorporate S.p.a

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2015-12-15
• Study First Submitted QC: 2015-12-16
• Study First Posted: 2015-12-21
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DELTA TT	Delta TT acetabular cup	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Azienda Ospedaliero-Universitaria di Ferrara, Arcispedale S. Anna; 🇮🇹 Cona, Ferrara, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica II; 🇮🇹 Torino, Italy

Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Dipartimento di Ortopedia, Traumatologia e Riabilitazione, Ospedale CTO, Clinica I; 🇮🇹 Torino, Italy

Azienda Ospedaliero-Universitaria di Udine, Santa Maria della Misericordia; 🇮🇹 Udine, Italy