Anterior Advantage With KINCISE

Mean femoral broach time (in minutes) was collected intraoperatively and begun at the time the box osteotome first enters the femoral canal and ended with seating of the final broach trial within the femoral canal.

Time frame: Day 0 (operative day)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not have any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

The FJS was a 12 question form that asks the participants their level of awareness of their artificial joint in 12 scenarios commonly encountered in daily life. Response to each question was individually scored (0 to 4, where 0=never, 1=almost never, 2=seldom, 3=sometimes and 4=mostly) and summed to create a raw composite score that was normalized to a range of 0 to 100 with a higher score indicating a better outcome (high degree of forgetting the artificial joint in everyday life).

Time frame: 6-week post-operative to 24 weeks post-operatively

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed)=who were evaluable for this outcome measure.

EQ-5D-5L was a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a vertical line VAS with scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). A higher score indicates better health and positive changes from baseline indicate improvement of health status.

Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D-5L dimensions were scored using a utility-weighted algorithm to derive an EQ-5D-5L health status index score between 0 (death) to 100 (full health). Higher score indicated better QoL.

Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

The HHS was developed for the assessment of the results of hip surgery. HHS was intended to evaluate various hip disabilities and methods of treatment in an adult population. It consisted of 10 items covering four domains: pain (1 item, 0-44 points), function ( 7 items \[limb, support, distance walked, stairs, socks/shoes, sitting and public transportation\], 0-47 points), deformity (1 item, 4 points) and range of hip motion (1 items, 5 points). HHS total score was the sum of 10 items scores and ranged from 0 (worse disability) to 100 (less disability). The higher score indicated better outcome for the participant. The scores were interpreted as follows: \< 70 = poor, 70-79 = fair, 80-89 = good and 90-100 = excellent. Day 0 was the operative day.

Time frame: Pre-operative baseline (6 months before operative day), 6 weeks and 24 weeks post-operative

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Length of hospital stay (in days) after index THA was calculated from date of discharge minus date of surgery.

Time frame: From operative day (Day 0) to date of discharge (any time from Day 0 to Day 5)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data.

Number of participants who received any narcotic pain medication to manage study hip pain was reported.

Time frame: From post operation (Day 0) to Week 24

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data.

Number of participants with optimal acetabular cup (a socket of the hip joint) abduction angle (movement of the leg away from the midline of the body) within +/- 10 degree of plan at Week 6 was reported.

Time frame: At Week 6 (post operative)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with optimal acetabular cup (a socket of the hip joint) version angle (rotation of leg in hip joint) within +/- 10 degrees of plan at Week 6 was reported.

Time frame: At Week 6 (post operative)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

Number of participants with pain (Groin, and Buttock) at Weeks 6 and 24 was reported. Participant's groin pain and buttock pain was reported either as none, mild, moderate, or severe.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants who experienced post-operative complication was reported.

Time frame: Day 0 (operative day) up to Week 24

Population: The safety population set consisted of all participants in the enrolled population set for whom treatment was attempted, according to the actual treatment received.

Participants were asked the following questions: Can you walk without an aid?, Do you drive?, Can you perform basic activities of daily living without assistance?, Can you perform light household duties?, Can you perform moderate to heavy household duties?, Can you go up and down a flight of stairs using a handrail?, Can you put on socks/stockings without someone's assistance?, Can you bend down to pick up an object on the floor?, Can you stand up from a chair without assistance?, Can you participate in leisure recreational activities?, Do you work? and When were you first able to accomplish the primary goal you identified after surgery?. Participants were asked to respond either as yes or No, because of study hip. Number of participants who reported response as yes at Week 6 were reported in this outcome measure.

Time frame: Week 6 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with post-operative satisfaction with the procedure at Weeks 6 and 24 was reported. Participants were asked a question that How satisfied do you anticipate you will be with this procedure? and participant responded on a 5-point scale (1=extremely satisfied, 2=very satisfied, 3=moderately satisfied, 4=slightly satisfied, 5=not at all satisfied). Higher score indicated low post-operative satisfaction.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcomes (acetabular cup migration, acetabular cup radiolucency, acetabular cup progressive radiolucency, acetabular cup osteolysis, acetabular cup sclerotic lines, acetabular cup porous coating integrity, femoral stem subsidence, femoral stem radiolucency, femoral stem osteolysis, calcar resorption, calcar fracture, femoral stem tilt and femoral stem porous coating integrity) were reported. In this outcome measure, only those timepoints in which participants had data were reported. In this outcome measure, each radiographic outcome assessment was reported either as present or absent in the analyzed participants.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (device/anatomy condition) were reported. Assessments were reported as intact or not intact.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (femoral stem position) were reported. Femoral stem position was assessed as neutral, varus and valgus.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with radiographic outcome (heterotopic ossification) were reported. Ossification is defined as formation of extraskeletal bone in muscle and soft tissues. Heterotopic ossification is the presence of bone in soft tissue where bone normally does not exist. Heterotopic ossification was classified as Class 0, I, II, III and IV where Class 0 indicates no evidence heterotopic bone formation, Class I indicates islands of bone within the soft tissue about the hip, Class II indicates bone spurs from the pelvis or proximal end of the femur, leaving at least a centimeter (cm) between opposing bone surfaces, Class III indicates bone spurs from the pelvis or proximal end of the femur, reducing the space between opposing bone surfaces to less than 1 cm, and Class IV indicates apparent bone ankylosis of the hip.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Number of participants with re-hospitalizations during the study was reported.

Time frame: Day 0 (operative day) to Day 90 (post-operative)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data.

Radiographic outcome was assessed on acetabular cup version (hip) and acetabular cup inclination and reported in this outcome measure.

Time frame: Weeks 6 and 24 (post-operative)

Population: Per protocol population set consisted of all participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, who did not had any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data. Here, 'N'(number of participants analyzed)=who were evaluable for this outcome measure, 'n'(number analyzed)=participant who were evaluated at specified timepoint.

Skin-to-skin is the time (in minutes) duration of the surgery procedure.

Time frame: Day 0 (operative day)

Population: Per protocol population set consisted of all enrolled participants who successfully received planned treatment, who met all inclusion/exclusion criteria, who were seen at least once at post-operative visit, and who did not have any protocol deviation which were prospectively determined to potentially had influence on scientific validity of data.