Primary Total Hip Replacement Clinical Trial
| Verified date | March 2016 |
| Source | Limacorporate S.p.a |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Italy: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 84 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | 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 I | Torino | |
| 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 di Udine, Santa Maria della Misericordia | Udine |
| Lead Sponsor | Collaborator |
|---|---|
| Limacorporate S.p.a |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The percentage change of the bone mineral density (BMD) around the acetabular cups with DEXA scan | From baseline to 5 year Follow-up | No | |
| Secondary | Harris Hip Score (HHS) | From baseline to 5 year Follow-up | No | |
| Secondary | SF-36 score | From baseline to 5 year Follow-up | No |