Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®
Primary Purpose
Osteoarthritis, Hip
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Total Hip Arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Hip
Eligibility Criteria
Inclusion Criteria:
- THA following a primary or secondary osteoarthritis
- THA following an aseptic osteonecrosis
- 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
- Rheumatoid arthritis
- Steroid treatment on-going
- Tumor Pathology of the hip bone
- 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
Sites / Locations
- Hopital Ambroise PareRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ACTISURF-CERAFIT
CERAFIT
Arm Description
Total hip arthroplasty (CERAFIT) grafted by PolyNass
Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) no grafted by PolyNass
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Infection rate
yes/no
Score ARA femur of Epinette
Adaptation criteria of the bone to the cementless stem
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Harris Hip Score (HHS)
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Postel Merle d'Aubigné (PMA) score
From 18 (perfect) to 0 (worst)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Forgotten Hip Score (FHS)
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
THA survival
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
THA survival
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
THA survival
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
Full Information
NCT ID
NCT03113981
First Posted
April 5, 2017
Last Updated
April 12, 2022
Sponsor
Laboratoire Ceraver-Osteal
1. Study Identification
Unique Protocol Identification Number
NCT03113981
Brief Title
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®
Official Title
Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2017 (Actual)
Primary Completion Date
May 1, 2023 (Anticipated)
Study Completion Date
May 1, 2036 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laboratoire Ceraver-Osteal
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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, biocompatibility, 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Hip
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ACTISURF-CERAFIT
Arm Type
Experimental
Arm Description
Total hip arthroplasty (CERAFIT) grafted by PolyNass
Arm Title
CERAFIT
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) no grafted by PolyNass
Intervention Type
Device
Intervention Name(s)
Total Hip Arthroplasty
Intervention Description
Implanting THA grafted with PolyNass or not
Primary Outcome Measure Information:
Title
Osseous-integration of the femoral stem and the acetabular component
Description
(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
Time Frame
1-year
Secondary Outcome Measure Information:
Title
Infection rate
Description
yes/no
Time Frame
2-year
Title
Score ARA femur of Epinette
Description
Adaptation criteria of the bone to the cementless stem
Time Frame
1-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
2-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
4-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
6-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
8-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
10-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
12-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
14-year
Title
Harris Hip Score (HHS)
Description
10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Time Frame
16-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
2-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
4-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
6-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
8-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
10-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
12-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
14-year
Title
Postel Merle d'Aubigné (PMA) score
Description
From 18 (perfect) to 0 (worst)
Time Frame
16-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
2-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
4-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
6-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
8-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
10-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
12-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
14-year
Title
Forgotten Hip Score (FHS)
Description
12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Time Frame
16-year
Title
THA survival
Description
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
Time Frame
6-year
Title
THA survival
Description
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
Time Frame
10-year
Title
THA survival
Description
Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
Time Frame
16-year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
THA following a primary or secondary osteoarthritis
THA following an aseptic osteonecrosis
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
Rheumatoid arthritis
Steroid treatment on-going
Tumor Pathology of the hip bone
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahnaz Klouche, MD
Phone
+628350478
Email
klouche_shahnaz@yahoo.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bauer, MD, PhD
Organizational Affiliation
Hospital Ambroise Paré Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Ambroise Pare
City
Boulogne-Billancourt
ZIP/Postal Code
92000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Bauer, MD, PhD
Email
thomas.bauer@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®
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