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

Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by Sodium Polystyrene Sulfonate -PolyNASS- (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Osteoarthritis, Hip; Hip Arthroplasty Replacement; Hip Arthroplasty; Osteonecrosis; Aseptic, Idiopathic; Coxarthrosis; Primary; Coxarthrosis; Secondary; Hip Arthroplasty, Total
• Intervention / Treatment: Device: Total Hip Arthroplasty

• Study Type: Interventional
• Enrollment (Actual): 340
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33076
    • CHU de Bordeaux Site Pellegrin
  • Boulogne-Billancourt, France, 92000
    • Hôpital Ambroise Paré
  • Brest, France, 29200
    • CH Privé Brestois et Clinique Pasteur
  • Brest, France, 29200
    • CHU Cavale Blanche
  • Paris, France, 75010
    • Hopital Lariboisière
  • Quimper, France, 29107
    • CH de Cornouaille
  • Strasbourg, France, 67200
    • HUS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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
• Immunocompromised patients
• Difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation) or understanding of the protocol
• Patient Refusal
• Pregnant and lactating women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ACTISURF-CERAFIT; Total hip arthroplasty (CERAFIT) grafted by PolyNass	Device: Total Hip Arthroplasty; Implanting THA grafted with PolyNass or not
Active Comparator: CERAFIT; Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) not grafted by PolyNass	Device: Total Hip Arthroplasty; Implanting THA grafted with PolyNass or not

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mid-term survival rate of the hip prosthesis	Based on the unipolar or bipolar change of the femoral head regardless of the cause, septic or mechanical.	15 years post-surgery for CERAFIT group and 16 years post-surgery for ACTISURF group
Score ARA femur of Epinette	Adaptation criteria of the bone to the cementless stem	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.	yes/no	2 years post-surgery for both groups
Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	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)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	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)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	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	Subsidence of the femoral stem, presence of periprosthetic radiolucent lines in the Gruen and Amstutz zones (femur) and in the DeLee and Charnley zones (acetabulum), Brooker score	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	Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)	6 years post-surgery for ACTISURF group. 10 years post-surgery for both groups.
Adverse and serious adverse events evaluation	Occurrence of related to THA serious adverse events after 2 post-operative years	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.

Collaborators and Investigators

• Sponsor: Societe ACTIVBIOMAT
• Collaborators: Slb Pharma
• Investigators: Principal Investigator: Thomas Bauer, MD, PhD, Hospital Ambroise Paré Paris

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2017
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): December 1, 2039

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Estimated): December 22, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Bone Diseases; Musculoskeletal Diseases; Pathologic Processes; Neoplasms; Arthritis; Joint Diseases; Rheumatic Diseases; Necrosis; Neoplastic Processes; Osteoarthritis; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Infertility; Osteoarthritis, Hip; Osteonecrosis; Surgical Procedures, Operative; Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Plastic Surgery Procedures; Prosthesis Implantation; Arthroplasty, Replacement, Hip
• Other Study ID Numbers: ACTISURF-OI-16; 2015-A01919-40 (Other Identifier: ID RCB - ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No