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NCT Number: NCT03113981

Osseointegration of THA Grafted by 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.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Diseases Coxarthrosis; Primary Coxarthrosis; Secondary Genital Diseases Hip Arthroplasty Hip Arthroplasty Replacement Hip Arthroplasty, Total Infertility Joint Diseases Musculoskeletal Diseases Necrosis Neoplasm Metastasis Neoplasms Neoplastic Processes Osteoarthritis Osteonecrosis Osteonecrosis; Aseptic, Idiopathic Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Urogenital Diseases

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux Site Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Total hip arthroplasty

Device

Implanting THA grafted with PolyNass or not

Primary outcomes

  1. 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

  1. Mid-term survival rate of the hip prosthesis

    Time frame: 15 years post-surgery for CERAFIT group and 16 years post-surgery for ACTISURF group

    Based on the unipolar or bipolar change of the femoral head regardless of the cause, septic or mechanical.

  2. Score ARA femur of Epinette

    Time frame: 1 year post-surgery for both groups

    Adaptation criteria of the bone to the cementless stem

  3. 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.

    Time frame: 2 years post-surgery for both groups

    yes/no

  4. Postel Merle d'Aubigné (PMA) score

    Time frame: 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.

    From 18 (perfect) to 0 (worst)

  5. Harris Hip Score (HHS)

    Time frame: 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.

    10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

  6. Forgotten Hip Score (FHS)

    Time frame: 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.

    12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)

  7. Osseous-integration of the femoral stem and the acetabular component based on radiographies

    Time frame: 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.

    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

  8. THA survival

    Time frame: 6 years post-surgery for ACTISURF group. 10 years post-surgery for both groups.

    Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)

  9. Adverse and serious adverse events evaluation

    Time frame: 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.

    Occurrence of related to THA serious adverse events after 2 post-operative years

Sponsors and collaborators

Lead sponsor

Societe ACTIVBIOMAT

Industry

Collaborators

  • Slb Pharma

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2024
Study completion
2039
First posted
Apr 14, 2017
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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