ATX Register Accolade Stem & Trident/Tritanium Cup With X... | NCT02520544

NCT02520544

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Accolade stem	Active Comparator	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.	Device: Accolade stem Device: Trident/Tritanium cup
Accolade II stem	Active Comparator	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner.	Device: Accolade II stem Device: Trident/Tritanium cup

Name	Type	Description	Arm Group Labels	Other Names
Accolade stem	Device	Total hip replacement	Accolade stem
Accolade II stem

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survivorship of the Device	Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).	10 years Follow-up

Secondary Outcomes

Measure	Description	Time Frame
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire	Scores can range from 0 to 100 with 0 being the worst and 100 being the best score. A score of 80-100 is considered good-excellent and a score of less than or equal to 79 is considered fair-poor. 90-100 = excellent 80-89 = good 70-79 = fair 0-69 = poor	pre-operative, 1, 3, 5, 7 and 10 years follow-up

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male and non-pregnant female patients between 18-75 years of age.
Patients requiring uncemented primary Total Hip Arthroplasty (THA), suitable for the use of the Accolade stem and Trident/Tritanium cup.
Patients with a diagnosis of osteoarthritis (OA).
Patients who understand the conditions of the study and are willing and able to comply with the post-operative scheduled clinical and radiographic evaluations and the prescribed rehabilitation.
Patients who signed the Ethics Committee approved Informed Consent Form prior to surgery.

Exclusion Criteria:

Patients who require revision of a previously implanted hip prosthesis.
Patients who had a THA on contralateral side within the last 6 months.
Patients who had a THA on contralateral side more than 6 months ago and the rehabilitation period outcome was considered unsatisfactory or not good (Harris Hip Score < 85).
Patients who will need lower limb joint replacement for another joint within one year.
Patients requiring bilateral hip replacement.
Patients who have had a prior procedure of acetabular osteotomy.
Patients with acute femoral fractures
Obese patients where obesity is severe enough to affect subject's ability to perform activities of daily living (body mass index, kg/m2: BMI ≥ 35).
Patients with active or suspected infection.
Patients with malignancy - active malignancy.
Patients with severe osteoporosis, rheumatoid arthritis (RA), Paget's disease or renal osteodystrophy.
Patients immunologically suppressed, or receiving steroids in excess of physiologic dose requirements.
The patient has a neuromuscular or neurosensory deficit which would limit the ability to assess the performance of the device or the patient has a neurological deficit which interferes with the patient's ability to limit weight bearing or places an extreme load on the implant during the healing period.
Female patients planning a pregnancy during the course of the study.
Patients with systemic or metabolic disorders leading to progressive bone deterioration.
Patients, who as judged by the surgeon, are mentally incompetent or are unlikely to be compliant with the prescribed post-operative routine and follow-up evaluation schedule.
Patients with other severe concurrent joint involvements, which can affect their outcome.
Patients with other concurrent illnesses, which are likely to affect their outcome such as sickle cell anaemia, systemic lupus erythematosus or renal disease requiring dialysis.
Patient with a known sensitivity to device materials.
Patients under the protection of law (e.g. guardianship).

Name	Affiliation	Role
Stefan Bolder, MD	Amphia Zieknhuis Breda	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ziekenhuis Netwerk Antwerpen		Antwerp			Belgium
St. Antonius Ziekenhuis

Arm/Group Information

ID	Title	Description
FG000	Accolade Stem	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner. Accolade stem: Total hip replacement Trident/Tritanium cup: Total hip replacement
FG001	Accolade II Stem	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner. Accolade II stem: Total hip replacement Trident/Tritanium cup: Total hip replacement

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Accolade Stem	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner. Accolade stem: Total hip replacement Trident/Tritanium cup: Total hip replacement
BG001

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Survivorship of the Device

Survivorship shown in Kaplan Meier survival curves (statistic used to estimate the survival function from lifetime data).

Outcome value for the 10-year post-operative timepoint is provided.

Posted

Number

95% Confidence Interval

percentage of participants not revised

10 years Follow-up

ID	Title	Description
OG000	Accolade Stem	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner. Accolade stem: Total hip replacement Trident/Tritanium cup: Total hip replacement
OG001	Accolade II Stem

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Accolade Stem	All patients in a participating centre matching all of the inclusion criteria and none of the exclusion criteria and who receive the Accolade or Accolade II stem and Trident/Tritanium cup with X3 liner. Accolade stem: Total hip replacement Trident/Tritanium cup: Total hip replacement

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Acetabular Insert Crack / Fracture - Operative Site	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Musculoskeletal	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Non-systematic Assessment