Trial Outcomes & Findings for Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail (NCT NCT05197335)
NCT ID: NCT05197335
Last Updated: 2026-01-20
Results Overview
Safety measurement outcome: the percentage of patients who, due to serious adverse events related to Chimaera, will have to undergo a second surgery to continue with the treatment of the proximal femur fracture.
Recruitment status
COMPLETED
Target enrollment
206 participants
Primary outcome timeframe
6 months
Results posted on
2026-01-20
Participant Flow
Participant milestones
| Measure |
Study Group
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
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Overall Study
STARTED
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206
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Overall Study
COMPLETED
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131
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Overall Study
NOT COMPLETED
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75
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
Baseline characteristics by cohort
| Measure |
Study Group
n=206 Participants
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=37 Participants
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=37 Participants
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Age, Categorical
>=65 years
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206 Participants
n=37 Participants
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Age, Continuous
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84.5 years
STANDARD_DEVIATION 7.2 • n=37 Participants
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Sex: Female, Male
Female
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171 Participants
n=37 Participants
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Sex: Female, Male
Male
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35 Participants
n=37 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Asian
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=37 Participants
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Race (NIH/OMB)
White
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206 Participants
n=37 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=37 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=37 Participants
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Region of Enrollment
Italy
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206 participants
n=37 Participants
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PRIMARY outcome
Timeframe: 6 monthsPopulation: Adult patients with a previously untreated proximal femur fracture who, in the Investigator's sole judgment, has a standard indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. Eligible patients who meet the following inclusion criteria and none of the exclusion criteria will be considered suitable for participation in this Clinical Investigation.
Safety measurement outcome: the percentage of patients who, due to serious adverse events related to Chimaera, will have to undergo a second surgery to continue with the treatment of the proximal femur fracture.
Outcome measures
| Measure |
Study Group
n=206 Participants
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
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Percentage of Patients Needing a Second Surgery
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0 Participants
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SECONDARY outcome
Timeframe: 12 monthsPopulation: Adult patients with a previously untreated proximal femur fracture who, in the Investigator's sole judgment, has a standard indication for surgical treatment with Chimaera will be considered eligible for participation in the clinical investigation. We report the Bowers \& Parker functional score results at one year after surgery (Visit 6), based on data from 129 patients who completed the assessment at this time point.
Efficacy measurement outcome: the functional score of Bowers \& Parker for the evaluation of the functional recovery of the patient. This score is made of three continuous scales defined for pain, mobility and functional independence. The Pain score is assessed from 0 (Unable to answer) to 8 (Constant and severe pain in the hip requiring regular strong analgesia such as opiates). The Mobility score is assessed from 1 (Never uses any walking aid and no restriction in walking distance) to 10 (Bedbound most or all of the day). The Functional score is assessed from 1 (Completely independent. Requires no assistance in basic or advanced activities of daily living (ADL) including shopping) to 8 (Patient temporarily resident in hospital requiring both nursing and medial care).
Outcome measures
| Measure |
Study Group
n=129 Participants
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
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Functional Score of Bowers & Parker
Mobility
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4.11 score on a scale
Standard Deviation 2.49
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Functional Score of Bowers & Parker
Independence
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3.14 score on a scale
Standard Deviation 1.75
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Functional Score of Bowers & Parker
Pain
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1.73 score on a scale
Standard Deviation 1.36
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Adverse Events
Study Group
Serious events: 79 serious events
Other events: 23 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
Study Group
n=206 participants at risk
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
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Injury, poisoning and procedural complications
Postoperative anemia
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6.8%
14/206 • Number of events 14 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Femur fracture
|
1.5%
3/206 • Number of events 3 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Wrist fracture
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Multiple fractures
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Hip fracture
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Head injury
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Injury, poisoning and procedural complications
Fracture and Fall
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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General disorders
Death
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10.7%
22/206 • Number of events 22 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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General disorders
Disease complication and Peripheral oedema peripheral
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Infections and infestations
COVID-19
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3.9%
8/206 • Number of events 8 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Infections and infestations
Endocarditis
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Infections and infestations
Klebsiella infection
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Infections and infestations
Sepsis
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Infections and infestations
Urinary tract infection
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Angina pectoris
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Atrial fibrillation
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0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Cardiac arrest
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0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Cardiac failure
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1.9%
4/206 • Number of events 4 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Cardio-respiratory arrest
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Cardiac disorders
Supraventricular extrasystoles
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
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Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
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0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Nervous system disorders
Cerebrovascular accident
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Nervous system disorders
Epilepsy
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0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Nervous system disorders
Transient ischaemic attack
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Nervous system disorders
Delirium
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Metabolism and nutrition disorders
Hyperglycaemia
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Metabolism and nutrition disorders
Hypokalaemia
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Metabolism and nutrition disorders
Marasmus
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Metabolism and nutrition disorders
Metabolic alkalosis
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Gastrointestinal disorders
Gastritis
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Gastrointestinal disorders
Intestinal obstruction
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Gastrointestinal disorders
Pancreatitis
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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|
Renal and urinary disorders
Renal failure
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Surgical and medical procedures
Red blood cell transfusion
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Vascular disorders
Arterial haemorrhage
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Vascular disorders
Embolism
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
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Psychiatric disorders
Delirium
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Other adverse events
| Measure |
Study Group
n=206 participants at risk
Age of 65 at the time of signing the informed consent.
Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws: The enrolled patients will proceed by undergoing the surgery necessary for the application of the medical device under observation (Chimaera), which coincides with the start of the treatment period.
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|---|---|
|
Infections and infestations
Urinary Infection
|
2.9%
6/206 • Number of events 6 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
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Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Nervous system disorders
Epilepsy
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
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Injury, poisoning and procedural complications
Anaemia postoperative
|
2.4%
5/206 • Number of events 5 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Renal and urinary disorders
Renal failure
|
0.97%
2/206 • Number of events 2 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
General disorders
Oedema peripheral
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Cardiac disorders
Atrial fibrillation
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
|
|
Psychiatric disorders
Delirium
|
0.49%
1/206 • Number of events 1 • Adverse events were monitored during the postoperative follow-up period of up to 6 months. The safety of the Chimaera device was assessed based on the percentage of patients who required a second surgical procedure due to serious adverse events related to the device.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place