Trial Outcomes & Findings for Secur-Fit Advanced Outcomes Study (NCT NCT01917929)

NCT ID: NCT01917929

Last Updated: 2025-07-23

Results Overview

The primary objective is to determine the success rate at 5 years postoperative with the Secur-Fit Advanced Hip Stem in the cementless application. Success is defined as absence of femoral stem revision and/or removal for aseptic loosening or device-related femoral fracture at 5 years postoperative.

Recruitment status

TERMINATED

Study phase

Target enrollment

326 participants

Primary outcome timeframe

5 years

Results posted on

2025-07-23

Participant Flow

There were 326 hips/participants enrolled in this study (no bilateral cases).

Of the 326 hips/participants enrolled and consented, there were 12 cases that were censored due to not having the study device implanted, surgery cancelled or due to an inclusion or exclusion violation. Therefore, 314 hips/participants (there were no bilateral cases) are followed who did receive the study device and met protocol criteria. Those applicable data are reflected in this record.

Participant milestones

Participant milestones
Measure	Secur-Fit Advanced Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Overall Study STARTED	326
Overall Study COMPLETED	38
Overall Study NOT COMPLETED	288

Reasons for withdrawal

Reasons for withdrawal
Measure	Secur-Fit Advanced Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Overall Study Death	8
Overall Study Lost to Follow-up	19
Overall Study Withdrawal by Subject	33
Overall Study Adverse Event	6
Overall Study Investigative Site Terminated	35
Overall Study Censored because study device not implanted	6
Overall Study Censored because surgery not performed	3
Overall Study Censored because of inclusion exclusion violation	3
Overall Study Sponsor terminated study	175

Baseline Characteristics

Secur-Fit Advanced Outcomes Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Secur-Fit Advanced n=314 Participants Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Age, Continuous	61.81 years n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants
Sex: Female, Male Male	163 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	286 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Participants/hips with available data up to 5 years or at the time of early study termination.

Outcome measures

Outcome measures
Measure	Secur-Fit Advanced n=314 Participants Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Rate of Revision for Aseptic Loosening or Device-related Femoral Fracture	0 Participants

SECONDARY outcome

Timeframe: 10 years

Population: Participants/hips with available data up to 10 years or at the time of early study termination.

To evaluate all-cause revision and removal rates with the Secur-Fit Advanced Hip Stem and compare with those reported for other primary hip stems in the literature.

Outcome measures

Outcome measures
Measure	Secur-Fit Advanced n=314 Participants Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
All-cause Revision and Removal Rate	6 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Participants/hips with available data from surgery to 30 days postoperative.

To evaluate rate of device-related femoral fracture among patients implanted with the Secur-Fit Advanced Hip Stem within 30 days postoperative, and compare with rates reported for other primary hip stems in the literature.

Outcome measures

Outcome measures
Measure	Secur-Fit Advanced n=314 Participants Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Rate of Device-related Femoral Fracture	1 Participants

SECONDARY outcome

Timeframe: Intraoperative

Population: Participants/hips with available data intraoperatively.

To demonstrate the close relationship between the seating height of the Secur-Fit Advanced Hip Stem and its associated femoral broach by intraoperatively measuring the component exposure or countersink upon final seating.

Outcome measures

Outcome measures
Measure	Secur-Fit Advanced n=314 Participants Secur-Fit Advanced Hip Stem Secur-Fit Advanced Hip Stem: Straight femoral stem intended for cementless, press-fit application.
Final Seating of Femoral Stem Flush seating on femoral stem	223 Participants
Final Seating of Femoral Stem Proud seating of femoral stem	82 Participants
Final Seating of Femoral Stem Countersunk seating of femoral stem	9 Participants

Adverse Events

Operative Site Events

Serious events: 14 serious events

Other events: 27 other events

Deaths: 0 deaths

Non Operative Site Events (Systemic)

Serious events: 4 serious events

Other events: 0 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	Operative Site Events n=314 participants at risk All adverse events whether serious or not that occurred within the study population of 314 participants/hips (there were no bilateral cases).	Non Operative Site Events (Systemic) n=314 participants at risk All serious systemic adverse events that occurred in the study population in the perioperative period (intraoperative to hospital discharge) in 314 participants/hips.
Blood and lymphatic system disorders Systemic Other	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.64% 2/314 • Number of events 2 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Renal and urinary disorders Urogenital	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Surgical and medical procedures Systemic Other	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Infections and infestations Deep Joint Infection	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Infections and infestations Superficial Wound Infection	0.64% 2/314 • Number of events 2 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Injury, poisoning and procedural complications Femoral Crack	0.64% 2/314 • Number of events 2 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Injury, poisoning and procedural complications Femoral Fracture	0.96% 3/314 • Number of events 3 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Musculoskeletal and connective tissue disorders Dislocation	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Musculoskeletal and connective tissue disorders Femoral Component Subsidence	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Musculoskeletal and connective tissue disorders Femoral Fracture	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Musculoskeletal and connective tissue disorders Tendonitis	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Injury, poisoning and procedural complications Operative Site Other	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.
Surgical and medical procedures Operative Site Other	0.32% 1/314 • Number of events 1 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.

Other adverse events

Other adverse events
Measure	Operative Site Events n=314 participants at risk All adverse events whether serious or not that occurred within the study population of 314 participants/hips (there were no bilateral cases).	Non Operative Site Events (Systemic) n=314 participants at risk All serious systemic adverse events that occurred in the study population in the perioperative period (intraoperative to hospital discharge) in 314 participants/hips.
Musculoskeletal and connective tissue disorders Bursitis	8.6% 27/314 • Number of events 29 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.	0.00% 0/314 • The study period during which the AEs must be reported is defined as the period from the initiation of any study procedures to the end of the study treatment follow-up at 10-years or study closure. The start of study procedures is considered to be the date of consent. Any AEs that met the protocol defined reportable events were required to be reported from the time of consent until study completion. Serious systemic adverse events that occurred within the perioperative period (intraoperative to hospital discharge) were required to be reported. All operative site events, regardless of seriousness or time of occurrence were required to be reported.

Additional Information

Kevin Barga, Senior Manager, Clinical Affairs

Stryker Orthopaedics

Phone: 201-831-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Each study investigator has independent publication privileges for their own center's results after multi-center publications are submitted. Sponsor requires review of publications. Sponsor shall not edit or influence the publications except to ensure that confidential information is not disclosed, no off-label device use is promoted, and that data is accurately represented. Any publications must be submitted to Stryker for review at least 60 days prior to submission of publication.
Publication restrictions are in place

Restriction type: OTHER