Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

NCT03113981 | Active Not Recruiting

• 2 other identifiers: ACTISURF-OI-162015-A01919-40
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 7

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

Conditions

Coxarthrosis; Primary; Osteonecrosis; Aseptic, Idiopathic; Hip Arthroplasty Replacement; Hip Arthroplasty, Total; Hip Arthroplasty; Osteoarthritis, Hip; Coxarthrosis; Secondary

Outcome Measures

Primary Outcomes (1)

• Osseous-integration of the femoral stem and the acetabular component

  (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

  1 year post-surgery for both groups

Secondary Outcomes (9)

• 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.

Study Arms (2)

ACTISURF-CERAFIT

EXPERIMENTAL

Total hip arthroplasty (CERAFIT) grafted by PolyNass

Device: Total Hip Arthroplasty

CERAFIT

ACTIVE COMPARATOR

Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) not grafted by PolyNass

Device: Total Hip Arthroplasty

Interventions

Total Hip Arthroplasty DEVICE

Implanting THA grafted with PolyNass or not

ACTISURF-CERAFIT; CERAFIT

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Allergy known to any component of prostheses
• Known hypersensitivity to polystyrene sulfonate resins
• Native cotyl with a diameter of less than 42mm or greater than 68mm
• Significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb
• Charcot's disease

Sponsors & Collaborators

• Societe ACTIVBIOMAT: lead
• Slb Pharma: collaborator

Study Sites (7)

CHU de Bordeaux Site Pellegrin

Bordeaux, 33076, France

Location

Hopital Ambroise Pare

Boulogne-Billancourt, 92000, France

Location

CH Privé Brestois et Clinique Pasteur

Brest, 29200, France

Location

CHU Cavale Blanche

Brest, 29200, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

CH de Cornouaille

Quimper, 29107, France

Location

HUS

Strasbourg, 67200, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip; Neoplasm Metastasis; Osteonecrosis; Infertility

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bone Diseases; Necrosis; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Thomas Bauer, MD, PhD

  Hospital Ambroise Paré Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 14, 2017
• Study Start: May 8, 2017
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 1, 2039
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)