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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03113981
• Other study ID #: ACTISURF-OI-16
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 8, 2017
• Est. completion date: May 1, 2039

Study information

• Verified date: December 2023
• Source: Laboratoire Ceraver-Osteal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 380
• Est. completion date: May 1, 2039
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Device:
• Total Hip Arthroplasty
Implanting THA grafted with PolyNass or not

Locations

Country	Name	City	State
France	Hopital Ambroise Pare	Boulogne-Billancourt

Sponsors (1)

Lead Sponsor	Collaborator
Laboratoire Ceraver-Osteal

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Infection rate	yes/no	2-year
Secondary	Score ARA femur of Epinette	Adaptation criteria of the bone to the cementless stem	1-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	2-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	4-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	6-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	8-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	10-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	12-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	14-year
Secondary	Harris Hip Score (HHS)	10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.	16-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	2-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	4-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	6-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	8-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	10-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	12-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	14-year
Secondary	Postel Merle d'Aubigné (PMA) score	From 18 (perfect) to 0 (worst)	16-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	2-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	4-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	6-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	8-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	10-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	12-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	14-year
Secondary	Forgotten Hip Score (FHS)	12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)	16-year
Secondary	THA survival	Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)	6-year
Secondary	THA survival	Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)	10-year
Secondary	THA survival	Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)	16-year