Trial Outcomes & Findings for The CHINA TFNA Study (NCT NCT03635320)

Last Updated: 2023-06-06

Results Overview

The number of achieving fracuture union at 24 weeks of each group will be counted and the percentage will be calculated. Fracture union success is a composite endpoint; in order for an individual subject's surgery implanted with TFNA or PFNA-II to be considered successful he/she must satisfy all of the following criteria: 1. No focal tenderness or lengthwise percussion pain, or abnormal movement 2. The frontal/lateral X-ray examination shows the vague or no fracture gap, or the continuous callus passing across the fracture line 3. No deformation or breakage is found in the test product

Recruitment status

COMPLETED

Study phase

Target enrollment

188 participants

Primary outcome timeframe

24 weeks

Results posted on

2023-06-06

Participant Flow

One hundred eighty-eight subjects were included in this study and randomly assigned to a study group; enrollment included 94 in the study group and 94 in the control group. Subjects were clinically followed after surgery at 1, 6, 12 and 24 weeks at the hospital.

Subjects required to meet inclustion/exclusion prior to receiving device. 4 subjects were screened but not randomized: 1 subject withdrew ICF before randomization, 1 subject didn't meet inclusion criteria 4, 1 subject met exclusion criteria 9 and 10, 1 subject met exclusion criteria 15.

Participant milestones

Participant milestones
Measure	TFNA Group (Study Group) intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Overall Study STARTED	94	94
Overall Study FAS	93	92
Overall Study PPS	81	83
Overall Study COMPLETED	82	86
Overall Study NOT COMPLETED	12	8

Reasons for withdrawal

Reasons for withdrawal
Measure	TFNA Group (Study Group) intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Overall Study not implanted the device	1	2
Overall Study Withdrawal by Subject	11	6

Baseline Characteristics

based on the FAS

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 24 weeks

Population: based on PPS

Outcome measures

Outcome measures
Measure	TFNA Group (Study Group) n=81 Participants intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) n=83 Participants intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Successful Fracture Union Rate 24 Weeks After Surgery	81 Participants	83 Participants

Adverse Events

TFNA Group (Study Group)

Serious events: 18 serious events

Other events: 93 other events

Deaths: 2 deaths

PFNA-II Group (Control Group)

Serious events: 16 serious events

Other events: 89 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	TFNA Group (Study Group) n=93 participants at risk intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) n=92 participants at risk intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Product Issues Device-related	0.00% 0/93 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.	0.00% 0/92 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.
Product Issues Non-device related	19.4% 18/93 • Number of events 22 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.	17.4% 16/92 • Number of events 21 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.

Other adverse events

Other adverse events
Measure	TFNA Group (Study Group) n=93 participants at risk intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) n=92 participants at risk intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
Product Issues Device related	0.00% 0/93 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.	0.00% 0/92 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.
Product Issues Non-device related	100.0% 93/93 • Number of events 362 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.	96.7% 89/92 • Number of events 361 • Adverse events and serious adverse events were recorded starting at the time of subject randomization, until subject completion of study (24 weeks follow-up visit after surgery). All AEs were followed until the AE resolved, stabilized, or the study was completed. Judged the relationship between them and the products, and summarized the occurrence types of AEs for the safety evaluation of the product.

Additional Information

Jie, Zhou

Johnson & Johnson Medical (Shanghai) Ltd.

Phone: +86 18600551010

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Principal investigator and institution will not be able to publish single-center study data until combined results of the multicenter study are published. If multicenter publication is not performed within 12 months after the end or if sponsor notifies principal investigator and institution in writing that the multicenter study results will not be published, the principal investigator and institution may publish the results of their studies separately in accordance with contract.
Publication restrictions are in place

Restriction type: OTHER

Measure	TFNA Group (Study Group) n=93 Participants intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation	PFNA-II Group (Control Group) n=92 Participants intramedullary nail 'Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation	Total n=185 Participants Total of all reporting groups
Age, Continuous	77.8 Years n=5 Participants • based on the FAS	74.1 Years n=7 Participants • based on the FAS	75.9 Years n=5 Participants • based on the FAS
Sex: Female, Male Female	64 Participants n=5 Participants • based on the FAS	59 Participants n=7 Participants • based on the FAS	123 Participants n=5 Participants • based on the FAS
Sex: Female, Male Male	29 Participants n=5 Participants • based on the FAS	33 Participants n=7 Participants • based on the FAS	62 Participants n=5 Participants • based on the FAS
Race/Ethnicity, Customized Han(Asian)	89 Participants n=5 Participants • based on the FAS	91 Participants n=7 Participants • based on the FAS	180 Participants n=5 Participants • based on the FAS
Race/Ethnicity, Customized Others	4 Participants n=5 Participants • based on the FAS	1 Participants n=7 Participants • based on the FAS	5 Participants n=5 Participants • based on the FAS
Medical history Osteoporosis · Yes	56 Participants n=5 Participants • based on the FAS	55 Participants n=7 Participants • based on the FAS	111 Participants n=5 Participants • based on the FAS
Medical history Osteoporosis · No	37 Participants n=5 Participants • based on the FAS	37 Participants n=7 Participants • based on the FAS	74 Participants n=5 Participants • based on the FAS
Medical history Malnutrition · Yes	13 Participants n=5 Participants • based on the FAS	14 Participants n=7 Participants • based on the FAS	27 Participants n=5 Participants • based on the FAS
Medical history Malnutrition · No	80 Participants n=5 Participants • based on the FAS	78 Participants n=7 Participants • based on the FAS	158 Participants n=5 Participants • based on the FAS
Medical history Anemia · Yes	42 Participants n=5 Participants • based on the FAS	38 Participants n=7 Participants • based on the FAS	80 Participants n=5 Participants • based on the FAS
Medical history Anemia · No	51 Participants n=5 Participants • based on the FAS	54 Participants n=7 Participants • based on the FAS	105 Participants n=5 Participants • based on the FAS
Medical history Hormone deficiency · Yes	1 Participants n=5 Participants • based on the FAS	0 Participants n=7 Participants • based on the FAS	1 Participants n=5 Participants • based on the FAS
Medical history Hormone deficiency · No	92 Participants n=5 Participants • based on the FAS	92 Participants n=7 Participants • based on the FAS	184 Participants n=5 Participants • based on the FAS
Medical history Diabetes · Yes	28 Participants n=5 Participants • based on the FAS	18 Participants n=7 Participants • based on the FAS	46 Participants n=5 Participants • based on the FAS
Medical history Diabetes · No	65 Participants n=5 Participants • based on the FAS	74 Participants n=7 Participants • based on the FAS	139 Participants n=5 Participants • based on the FAS
Medical history Smoke within one year · Yes	5 Participants n=5 Participants • based on the FAS	5 Participants n=7 Participants • based on the FAS	10 Participants n=5 Participants • based on the FAS
Medical history Smoke within one year · No	88 Participants n=5 Participants • based on the FAS	87 Participants n=7 Participants • based on the FAS	175 Participants n=5 Participants • based on the FAS
Medical history Drink within one year · Yes	3 Participants n=5 Participants • based on the FAS	5 Participants n=7 Participants • based on the FAS	8 Participants n=5 Participants • based on the FAS
Medical history Drink within one year · No	90 Participants n=5 Participants • based on the FAS	87 Participants n=7 Participants • based on the FAS	177 Participants n=5 Participants • based on the FAS