Trial Outcomes & Findings for Large Head X3 Study (NCT NCT02543437)

Results Overview

Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

Recruitment status

UNKNOWN

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Intraoperative

Results posted on

2018-10-15

Participant Flow

117 participants / 120 hips enrolled in study.

Participant milestones

Participant milestones
Measure	Trident Acetabular X3 Insert Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
Overall Study STARTED	117
Overall Study COMPLETED	117
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Large Head X3 Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	X3 Liner n=117 Participants X3 28mm, 32mm and 36mm liner Trident Acetabular X3 Insert
Age, Continuous	63.3 years STANDARD_DEVIATION 9.1 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Japan	117 participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative

Population: Comparison between 28mm liner and 36mm line. Participants with available data : 119 hips in 117 participants.

Measure and compare the ROM using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

Outcome measures

Outcome measures
Measure	X3 Liner n=119 Hips X3 28mm, 32mm and 36mm liner Trident Acetabular X3 Insert
Range of Motion(ROM) (Degree) Maximam Flexion	2.6 Degree Standard Deviation 4.5
Range of Motion(ROM) (Degree) Maximam Extension	2.6 Degree Standard Deviation 4.7
Range of Motion(ROM) (Degree) Maximam Abduction	2.6 Degree Standard Deviation 4.5

PRIMARY outcome

Timeframe: Intraoperative

Population: participants with available data : 100 hips in 100 participants.

Measure and compare the lift off distance in dislocation maneuver using femoral head trials of 36mm- and 28mm-diameter during intraoperative confirmation.

Outcome measures

Outcome measures
Measure	X3 Liner n=100 Hips X3 28mm, 32mm and 36mm liner Trident Acetabular X3 Insert
Lift Off Distance in Dislocation Maneuver(mm) Cup inclination	-0.2 mm Standard Deviation 3.5
Lift Off Distance in Dislocation Maneuver(mm) Cup anteversion	1.4 mm Standard Deviation 5.3
Lift Off Distance in Dislocation Maneuver(mm) Stem anteversion	-1.2 mm Standard Deviation 6.4

SECONDARY outcome

Timeframe: 1 year, 2 years, 3 years and 5 years after surgery

Retrospective comparison of the wear amount over time between X3 liner and Crossfire insert.

Outcome measures

Outcome data not reported

Adverse Events

X3 Liner

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yasuyuki Inatsugu, Associate manager of clinical affairs

Stryker Japan

Phone: 81 3 6894 8394

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place