Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by Sodium Polystyrene Sulfonate -PolyNASS- (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Societe ACTIVBIOMAT
- Enrollment
- 340
- Locations
- 7
- Primary Endpoint
- Osseous-integration of the femoral stem and the acetabular component
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.
The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.
Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.
A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.
No previous clinical trial
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged over 50 and under 75 years OR aged under 50 years with joint lesions not amenable to successful conservative treatment.
- •THA following a primary or secondary osteoarthritis
- •THA following an aseptic osteonecrosis
- •THA following a rapidly destructive osteoarthritis
- •Social insurance
- •Informed and signed consent
Exclusion Criteria
- •Patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment
- •Inflammatory rheumatism
- •Long-term corticosteroid treatment
- •Tumor Pathology of the hip bone
- •Study femoral stem not adapted to the patient's anatomy (verified on preoperative X-rays using Ceraver templates).
- •Loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis
- •Acetabular or femoral bone graft associated
- •Infectious hip arthritis history
- •Evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy
- •Surgical history on the affected hip
Outcomes
Primary Outcomes
Osseous-integration of the femoral stem and the acetabular component
Time Frame: 1 year post-surgery for both groups
(Yes/No). THA will be judged "osseointegrated" if the acetabulum AND the femur meet the following osseous-integration criteria: * femur: score of Engh and Massin strictly greater than 10 * AND acetabulum: Implant migration less than 5 mm AND no total radiolucent line and no osteocondensation at the bone-cup interface in the 3 zones of Gruen
Secondary Outcomes
- Mid-term survival rate of the hip prosthesis(15 years post-surgery for CERAFIT group and 16 years post-surgery for ACTISURF group)
- Score ARA femur of Epinette(1 year post-surgery for both groups)
- Hip prosthesis infection rate defined according to the 2011 criteria of the Musculoskeletal Infection Society (MSIS). In case of suspicion of infection, a hip joint aspiration with synovial fluid culture will be performed.(2 years post-surgery for both groups)
- Postel Merle d'Aubigné (PMA) score(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Harris Hip Score (HHS)(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Forgotten Hip Score (FHS)(2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- Osseous-integration of the femoral stem and the acetabular component based on radiographies(2 years post-surgery for both groups. 5 and 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.)
- THA survival(6 years post-surgery for ACTISURF group. 10 years post-surgery for both groups.)
- Adverse and serious adverse events evaluation(For ACTISURF group: at 4, 6, 8, 10, 12, 14, 16 years post-surgery. For CERAFIT group: at 5, 10, and 15 years post-surgery.)