Osteoarthritis, HipNCT03113981
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip and Coxarthrosis; Primary, run by Societe ACTIVBIOMAT at 7 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Osteoarthritis, Hip, Coxarthrosis; Primary, Coxarthrosis; Secondary
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 7 sitesFrance
- Study dates
- 8 May 2017to Dec 2039
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU de Bordeaux Site Pellegrin
Bordeaux, 33076
Hopital Ambroise Pare
Boulogne-Billancourt, 92000
CH Privé Brestois et Clinique Pasteur
Brest, 29200
CHU Cavale Blanche
Brest, 29200
Hôpital Lariboisière
Paris, 75010
CH de Cornouaille
Quimper, 29107
HUS
Strasbourg, 67200
About this study
Official title: 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.
Read more
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
- Osteoarthritis, Hip, Coxarthrosis; Primary, Coxarthrosis; Secondary, Osteonecrosis; Aseptic, Idiopathic, Hip Arthroplasty Replacement, Hip Arthroplasty, Total
- Being tested
- Total Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Hip, Neoplasm Metastasis, Osteonecrosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyDevice
Implanting THA grafted with PolyNass or not
| Study group | Role | What they receive |
|---|---|---|
| ACTISURF-CERAFIT | Experimental | Total hip arthroplasty (CERAFIT) grafted by PolyNass Receives: Device: Total Hip Arthroplasty |
| CERAFIT | Active comparator | Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) not grafted by PolyNass Receives: Device: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year post-surgery for both groups
Secondary outcomes (9)
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.
Measured: 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
Measured: 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
Measured: 2 years post-surgery for both groups
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start8 May 2017
- Primary completion31 Dec 2024
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe ACTIVBIOMAT
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Slb Pharma
- Responsible party
- Sponsor
- Investigators
- Thomas Bauer, MD, PhD, Principal investigator, Hospital Ambroise Paré Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113981
- Sponsor's protocol ID
- ACTISURF-OI-16
- Other IDs
- 2015-A01919-40
- Status last verified
- Dec 2025
- First submitted
- 5 Apr 2017
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No