Hip Arthroplasty Replacement Clinical Trial
Official title:
Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate
| NCT number | NCT01454271 |
| Other study ID # | CERAVERBIO11 |
| Secondary ID | 2011-A00597-34 |
| Status | Withdrawn |
| Phase | Phase 1/Phase 2 |
| First received | |
| Last updated |
| Verified date | August 2018 |
| Source | Laboratoire Ceraver-Osteal |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Age less than 75 years old - Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis Exclusion Criteria: - Previous infectious hip arthritis - Previous surgeries on the operated hip - Revision of THA |
| Country | Name | City | State |
|---|---|---|---|
| France | Ambroise Paré Hospital. Orthopaedic surgery department | Boulogne-Billancourt | Ile De France |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratoire Ceraver-Osteal |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Femoral component osseous-integration | Scoring system of Engh | 1 year after surgery | |
| Secondary | Infection rate | Infection (yes/no) : Clinical, biological or radiological THA infection signs. In the case of infection suspicion, hip aspiration will be performed with joint fluid culture |
1 year after surgery | |
| Secondary | Quality of Life | SF-36 score | One, three, six and twelve months after surgery |