Trial Outcomes & Findings for ATX Register Accolade Stem & Trident/Tritanium Cup With X3 Insert (NCT NCT02520544)

NCT ID: NCT02520544

Last Updated: 2026-01-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 472 participants
• Primary outcome timeframe: 10 years Follow-up
• Results posted on: 2026-01-26

Participant Flow

There were 472 participants that were enrolled into the study between January 2012 and February 2015.

Of the 472 participants enrolled, 49 cases were censored and excluded from the final analysis. 23 cases did not have a study device implanted, 4 cases did not have their surgery performed, 1 case voluntarily withdrew, 1 case had surgery performed after enrolment window, and 20 cases had inclusion/exclusion criteria violations. Of the remaining 423 participants, there were no bilateral cases.

Participant milestones

Measure	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	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
Overall Study STARTED	289	134
Overall Study COMPLETED	229	102
Overall Study NOT COMPLETED	60	32

Reasons for withdrawal

Measure	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	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
Overall Study Death	18	8
Overall Study Lost to Follow-up	8	8
Overall Study Withdrawal by Subject	23	11
Overall Study Revision/Removal of Study Device	11	5

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Accolade Stem n=289 Participants 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	Accolade II Stem n=134 Participants 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	Total n=423 Participants Total of all reporting groups
Age, Continuous	60.71 years STANDARD_DEVIATION 7.46 • n=289 Participants	59.76 years STANDARD_DEVIATION 8.01 • n=134 Participants	60.41 years STANDARD_DEVIATION 7.66 • n=423 Participants
Sex: Female, Male Female	161 Participants n=289 Participants	72 Participants n=134 Participants	233 Participants n=423 Participants
Sex: Female, Male Male	128 Participants n=289 Participants	62 Participants n=134 Participants	190 Participants n=423 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Netherlands	267 participants n=289 Participants	45 participants n=134 Participants	312 participants n=423 Participants
Region of Enrollment Sweden	0 participants n=289 Participants	32 participants n=134 Participants	32 participants n=423 Participants
Region of Enrollment Belgium	22 participants n=289 Participants	24 participants n=134 Participants	46 participants n=423 Participants
Region of Enrollment United Kingdom	0 participants n=289 Participants	33 participants n=134 Participants	33 participants n=423 Participants

PRIMARY outcome

Timeframe: 10 years Follow-up

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

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

Outcome measures

Measure	Accolade Stem n=289 Participants 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	Accolade II Stem n=134 Participants 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
Survivorship of the Device	97.03 percentage of participants not revised Interval 94.15 to 98.51	98.27 percentage of participants not revised Interval 93.19 to 99.57

SECONDARY outcome

Timeframe: pre-operative, 1, 3, 5, 7 and 10 years follow-up

Population: Outcome values for the modified HHS provided at pre-operative and all post-operative timepoints.

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

Outcome measures

Measure	Accolade Stem n=289 Participants 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	Accolade II Stem n=134 Participants 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
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire Preoperative	59.73 units on a scale Standard Deviation 11.60	58.47 units on a scale Standard Deviation 11.08
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire 1 year	95.08 units on a scale Standard Deviation 8.58	93.34 units on a scale Standard Deviation 9.61
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire 3 years	94.89 units on a scale Standard Deviation 8.10	95.07 units on a scale Standard Deviation 7.69
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire 5 years	95.37 units on a scale Standard Deviation 8.32	95.39 units on a scale Standard Deviation 8.10
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire 7 years	94.08 units on a scale Standard Deviation 9.19	94.24 units on a scale Standard Deviation 8.93
Investigation of Clinical Performance and Patient Outcome With Modified Harris Hip Score (HHS) Patient Questionnaire 10 years	93.73 units on a scale Standard Deviation 9.77	94.23 units on a scale Standard Deviation 9.20

SECONDARY outcome

Timeframe: pre-operative, 1, 3, 5, 7 and 10 years follow-up

Population: OHS values provided for pre-operative and all post-operative follow up timepoints.

Outcome instrument which contains 12 questions on activities of daily living that assess function and residual pain in patients undergoing total hip replacement (THR) surgery, each scored from 0-4 (worst to best), giving a final score with a total range of 0-48. A final score of 0 to 19 indicates severe hip arthritis, 20-29 indicates moderate to severe symptoms, 30-39 indicates mild to moderate symptoms, and 40 to 48 indicates satisfactory joint function.

Outcome measures

Measure	Accolade Stem n=289 Participants 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	Accolade II Stem n=134 Participants 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
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire Pre-operative	24.55 units on a scale Standard Deviation 8.06	22.47 units on a scale Standard Deviation 7.54
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire 1 year	43.98 units on a scale Standard Deviation 5.60	44.20 units on a scale Standard Deviation 5.25
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire 3 years	44.70 units on a scale Standard Deviation 5.36	44.84 units on a scale Standard Deviation 4.72
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire 5 years	45.16 units on a scale Standard Deviation 5.23	45.79 units on a scale Standard Deviation 3.82
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire 7 years	45.14 units on a scale Standard Deviation 4.97	44.49 units on a scale Standard Deviation 5.91
Investigation of Clinical Performance and Patient Outcome With Oxford Hip Score Patient Questionnaire 10 years	44.98 units on a scale Standard Deviation 4.66	44.75 units on a scale Standard Deviation 5.05

SECONDARY outcome

Timeframe: pre-operative, 1, 3, 5, 7 and 10 years follow-up

Population: EQ-5D values are provided for the VAS and TTO scores at the preoperative and all postoperative follow up timepoints.

The EQ-5D is a subject-completed questionnaire designed to assess subject health state values. The EQ-5D consists of 2 areas: the EQ visual analogue scale (EQ VAS) and the EQ-5D descriptive system, time trade-off (TTO).

The EQ VAS collects health state values using a 20 cm visual analogue scale with the endpoints labeled best imaginable health state at the top and worst imaginable health state at the bottom, having numeric values of 100 to 0 respectively.

The EQ-5D Time Trade-off (TTO) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/comfort and anxiety/depression. Each dimension has three levels: no problems, some problems and extreme problems. The TTO index values on a scale between -1(low) and 1(high) show the average health status according to the 5 dimensions. A low score shows worse health, and a high score shows better health.

Outcome measures

Measure	Accolade Stem n=289 Participants 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	Accolade II Stem n=134 Participants 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
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS Preoperative	66.8 units on a scale Standard Deviation 16.9	66.9 units on a scale Standard Deviation 19.0
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 1 year follow up	81.3 units on a scale Standard Deviation 12.4	83.1 units on a scale Standard Deviation 14.8
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 3 years follow up	79.7 units on a scale Standard Deviation 13.1	81.0 units on a scale Standard Deviation 14.5
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 5 years follow up	79.8 units on a scale Standard Deviation 14.2	81.1 units on a scale Standard Deviation 15.3
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 7 years follow up	78.3 units on a scale Standard Deviation 14.2	79.6 units on a scale Standard Deviation 15.2
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D VAS 10 years follow up	77.7 units on a scale Standard Deviation 14.3	78.2 units on a scale Standard Deviation 13.8
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO Preoperative	0.505 units on a scale Standard Deviation 0.260	0.471 units on a scale Standard Deviation 0.284
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO 1 year follow up	0.871 units on a scale Standard Deviation 0.185	0.866 units on a scale Standard Deviation 0.201
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO 3 years follow up	0.874 units on a scale Standard Deviation 0.185	0.846 units on a scale Standard Deviation 0.218
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO 5 years follow up	0.865 units on a scale Standard Deviation 0.210	0.891 units on a scale Standard Deviation 0.180
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO 7 years follow up	0.849 units on a scale Standard Deviation 0.201	0.866 units on a scale Standard Deviation 0.213
Investigation of Clinical Performance and Patient Outcome With EuroQuol-5 Dimension (EQ-5D) Patient Questionnaire EQ-5D TTO 10 years follow up	0.846 units on a scale Standard Deviation 0.227	0.867 units on a scale Standard Deviation 0.195

Adverse Events

Accolade Stem

Serious events: 92 serious events

Other events: 36 other events

Deaths: 18 deaths

Accolade II Stem

Serious events: 56 serious events

Other events: 41 other events

Deaths: 8 deaths

Serious adverse events

Measure	Accolade Stem n=289 participants at risk 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	Accolade II Stem n=134 participants at risk 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
Vascular disorders Cardiovascular - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Acetabular Insert Crack / Fracture - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Dislocation - Operative Site	1.0% 3/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	3.0% 4/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Excessive Hip Pain - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Femoral Component Loosening - Operative Site	1.7% 5/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Surgical and medical procedures Femoral Component Subsidence - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Femoral Crack / Fracture - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Infections and infestations Superficial Wound Infection - Operative Site	0.69% 2/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Skin and subcutaneous tissue disorders Superficial Wound Infection - Operative Site	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Tendonitis - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Injury, poisoning and procedural complications Wound Hematoma - Operative Site	1.0% 3/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Infections and infestations Wound Related - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Skin and subcutaneous tissue disorders Wound Related - Operative Site	0.69% 2/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Osteolysis - Operative Site	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pseudotumour - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Infections and infestations Other - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Other - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Impingement - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Injury, poisoning and procedural complications Other - Operative Site	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Operative Site - Other	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary / Respiratory - Systemic	3.5% 10/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Carcinoma / Cancer - Systemic	7.3% 21/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	9.7% 13/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Cardiac disorders Cardiovascular - Systemic	5.2% 15/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	3.7% 5/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Skin and subcutaneous tissue disorders Dermatological - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Vascular disorders Deep Vein Thrombosis (DVT) - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Gastrointestinal disorders Gastrointestinal / Digestive - Systemic	2.4% 7/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	4.5% 6/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Renal and urinary disorders Genitourinary / Urogenital - Systemic	2.1% 6/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	1.5% 2/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Musculoskeletal - Systemic	4.5% 13/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	8.2% 11/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Nervous system disorders Musculoskeletal - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Nervous system disorders Neurosensory / Neurological - Systemic	3.1% 9/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	3.7% 5/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Vascular disorders Neurosensory / Neurological - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Vascular disorders Pulmonary Embolism - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	1.5% 2/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Vascular disorders Thrombophlebitis - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Injury, poisoning and procedural complications Trauma - Systemic	1.0% 3/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
General disorders Death, Cause Unknown - Systemic	1.0% 3/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	2.2% 3/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Gastrointestinal disorders Abdominal Pain - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	1.5% 2/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Infections and infestations Infection, Non-operative site - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	2.2% 3/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Necrotizing Fascitis, Non-operative site - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Musculoskeletal and connective tissue disorders Haematoma, Non-operative site - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Injury, poisoning and procedural complications Epistaxis, Non-operative site - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Injury, poisoning and procedural complications Wound Related, Non-operative site - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Vascular disorders Giant Cell Artheritis - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Product Issues Bearing Wear, Non-operative Side - Systemic	0.35% 1/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.00% 0/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.
Reproductive system and breast disorders Gynaecological - Systemic	0.00% 0/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	0.75% 1/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.

Other adverse events

Measure	Accolade Stem n=289 participants at risk 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	Accolade II Stem n=134 participants at risk 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
Musculoskeletal and connective tissue disorders Musculoskeletal	12.5% 36/289 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.	30.6% 41/134 • The study period during which AEs must be reported is defined as the period from the initiation of any study procedures to end of the study treatment follow-up. The start of study procedures is considered to be the date of consent. Adverse events were collected pre-operatively after enrolment and prior to surgery, intra-operatively, and over the 10-year post-operative time period up until the point of study termination.

Additional Information

Kevin Barga, Director, Clinical Affairs

Stryker Orthopaedics

Phone: 201-831-5000

Email: kevin.barga@stryker.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may publish after study completion and prior multi-center publication, provided Sponsor reviews materials at least 15 working days before submission. Reasonable comments will be incorporated. Sponsor may request a delay of up to 1 month to protect proprietary information. For multi-center trials, site-specific publications cannot occur before the first multi-center publication unless otherwise agreed
• Publication restrictions are in place

Restriction type: OTHER