Trial Outcomes & Findings for Retrospective Study Chimaera Long Nail in Adult Patient (NCT NCT06285981)

Last Updated: 2025-09-15

Results Overview

The clinical benefit of CHIMAERATM will be assessed by the percentage of patients in which bone union has been achieved within 12 months from the nail implant.

Recruitment status

COMPLETED

Target enrollment

44 participants

Primary outcome timeframe

12 months

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With Femur Fractures adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Overall Study STARTED	44
Overall Study COMPLETED	44
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Retrospective Study Chimaera Long Nail in Adult Patient

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Femur Fractures n=44 Participants adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur Chimaera Long Nail: The CHIMAERATM, is an internal fixation system intended intended for insertion into the medullary canal of a femur in individuals suffering from stable and unstable pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur alone or when these fractures occur in combination with shaft fractures extending distally to a point approximately 10cm proximal to the intercondylar notch.
Age, Customized Age	74 years STANDARD_DEVIATION 14.5 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Only 42 out of 44 enrolled patient were analysed for the performance endpoint because Two patients did not meet the CIP criteria for the primary endpoint evaluation and were not included in the efficacy analysis of clinical benefit, but were included in study evaluation for safety.

The clinical benefit of CHIMAERATM will be assessed by the percentage of patients in which bone union has been achieved within 12 months from the nail implant.

Outcome measures

Outcome measures
Measure	Patients With Femur Fractures n=42 Participants adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Percent of Patients in Which Bone Union Has Been Achieved	42 Participants

SECONDARY outcome

Timeframe: 6 months

The safety profile of CHIMAERATM will be assessed through the percentage of patients that required a reoperation (i.e., additional surgery).

Outcome measures

Outcome measures
Measure	Patients With Femur Fractures n=44 Participants adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Percent of Patients That Required a Reoperation	0 Participants

Adverse Events

Patients With Femur Fractures

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Patients With Femur Fractures n=44 participants at risk adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Infections and infestations Deep infection	2.3% 1/44 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Fracture	2.3% 1/44 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Patients With Femur Fractures n=44 participants at risk adult patients with pertrochanteric, intertrochanteric and subtrochanteric fractures of the femur
Infections and infestations Covid Infection	2.3% 1/44 • Number of events 1 • 1 year
Surgical and medical procedures Anemia	2.3% 1/44 • Number of events 1 • 1 year

Additional Information

Clinical Program Manager

Orthofix

Phone: 0456719077

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place