Trial Outcomes & Findings for Symmetric on Total Knee Arthroplasty (TKA) (NCT NCT03305887)

NCT ID: NCT03305887

Last Updated: 2020-01-13

Results Overview

The total time required to close the surgical incisions between treatment groups.

Recruitment status

COMPLETED

Study phase

Target enrollment

184 participants

Primary outcome timeframe

During Surgery

Results posted on

2020-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	STRATAFIX Symmetric PDS Plus an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)	Conventional Sutures Conventional Sutures is VICRYL Plus(Polyglactin 910)
Overall Study STARTED	91	93
Overall Study COMPLETED	80	83
Overall Study NOT COMPLETED	11	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Symmetric on Total Knee Arthroplasty (TKA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	STRATAFIX Symmetric PDS Plus n=91 Participants an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)	Conventional Sutures n=93 Participants Conventional Sutures is VICRYL Plus(Polyglactin 910)	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	30 Participants n=7 Participants	65 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	63 Participants n=7 Participants	119 Participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants	68 Participants n=7 Participants	138 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	25 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	91 Participants n=5 Participants	93 Participants n=7 Participants	184 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: During Surgery

Population: total 184 patients enrolled in this study, and 5 patients have no suture time, because they withdrawn from study before surgery or violated protocol, etc.

The total time required to close the surgical incisions between treatment groups.

Outcome measures

Outcome measures
Measure	STRATAFIX Symmetric PDS Plus n=90 Participants an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)	Conventional Sutures n=89 Participants Conventional Sutures is VICRYL Plus(Polyglactin 910)
Suturing Time	15.516 minuts Interval 3.083 to 30.2	20.864 minuts Interval 10.267 to 43.617

Adverse Events

STRATAFIX Symmetric PDS Plus

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Conventional Sutures

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	STRATAFIX Symmetric PDS Plus n=90 participants at risk an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone) total 90 patients had been collected Adverse Events(AE) related data, and 1 patient has no data in this group.	Conventional Sutures n=89 participants at risk Conventional Sutures is VICRYL Plus (Polyglactin 910) total 89 patients had been collected Adverse Events(AE) related data, and 4 patient has no AE data in Conventional Sutures group.
Musculoskeletal and connective tissue disorders Postoperative pain/postoperative exudation	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders Incision subcutaneous hemorrhage and Incision exudate	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders inflammatory reaction	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Incision infection	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Pain after knee replacement	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.

Other adverse events

Additional Information

Xiaolei, Wang

Johnson & Johnson Medical Shanghai Ltd.

Phone: +86 21 33378749

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The disclosure restriction on the principal investigator(PI) is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER

Measure	STRATAFIX Symmetric PDS Plus n=90 participants at risk an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone) total 90 patients had been collected Adverse Events(AE) related data, and 1 patient has no data in this group.	Conventional Sutures n=89 participants at risk Conventional Sutures is VICRYL Plus (Polyglactin 910) total 89 patients had been collected Adverse Events(AE) related data, and 4 patient has no AE data in Conventional Sutures group.
Blood and lymphatic system disorders white blood cell increment	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Blood and lymphatic system disorders red blood cell decrement	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Blood and lymphatic system disorders monocytes increment	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders inflammatory reaction	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	2.2% 2/89 • Number of events 2 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders Incision inflammation	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	2.2% 2/89 • Number of events 2 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Limb swelling （left）	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Hemorrhagic seepage of wound	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Tension vesicle around the wound	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders seepage of wound	2.2% 2/90 • Number of events 2 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders Hemorrhagic infiltration of wound	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders Hemorrhagic seepage of wound	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Musculoskeletal and connective tissue disorders lower limb swelling	1.1% 1/90 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	0.00% 0/89 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Blood and lymphatic system disorders hypokalemia	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Skin and subcutaneous tissue disorders Contagious eczema rash	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Immune system disorders drug fever	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.
Blood and lymphatic system disorders hypoalbuminemia	0.00% 0/90 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.	1.1% 1/89 • Number of events 1 • 42 days An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.