Osseointegration of THA Grafted by PolyNASS (ACTISURF-CER... | NCT03113981

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

NCT03113981

Sponsor

Societe ACTIVBIOMAT

Status

Active, not recruiting

Last Update Posted

Dec 22, 2025Actual

Enrollment

340Actual

Phase

Not Applicable

Conditions

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

Interventions

Total Hip Arthroplasty

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
2015-A01919-40	Other Identifier	ID RCB - ANSM

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2017Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Dec 2039Estimated

First Submitted Date

Apr 5, 2017

First Submission Date that Met QC Criteria

Apr 10, 2017

First Posted Date

Apr 14, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2025

Last Update Posted Date

Dec 22, 2025Actual

Name	Class
Slb Pharma	OTHER

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

340Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Total Hip Arthroplasty	Device	Implanting THA grafted with PolyNass or not	ACTISURF-CERAFIT CERAFIT

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

74 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Bordeaux Site Pellegrin		Bordeaux		33076	France
Hopital Ambroise Pare

ID	Term
D015207	Osteoarthritis, Hip
D009362	Neoplasm Metastasis
D010020	Osteonecrosis
D007246	Infertility

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases
D009385	Neoplastic Processes
D009369	Neoplasms
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D001847	Bone Diseases
D009336	Necrosis
D000091662	Genital Diseases
D000091642	Urogenital Diseases

ID	Term
D019643	Arthroplasty, Replacement
D001178	Arthroplasty
D019637	Orthopedic Procedures
D013514	Surgical Procedures, Operative
D019651	Plastic Surgery Procedures
D019919	Prosthesis Implantation