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Observational Clinical Study on Elderly Patients With Fracture of the Proximal Femur Treated With the Chimaera Nail
trial testing Chimaera short nail (length = 180 mm) in combination with one or two telescopic cephalic screws in Hip Fractures in 206 participants. Completed in 31 July 2022.
| Lead sponsor | Orthofix s.r.l. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 206 |
| Start date | 9 July 2020 |
| Primary completion | 31 March 2022 |
| Estimated completion | 31 July 2022 |
| Sites | 8 locations across Italy |
Orthofix s.r.l.
65 and older, any sex, with Hip Fractures or Subtrochanteric Fractures. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 0 |
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. Requi
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 4.11 | ± 2.49 |
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 3.14 | ± 1.75 |
| Group | Value | 95% CI |
|---|---|---|
| Study Group | 1.73 | ± 1.36 |
Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Study Group |
|---|---|---|
| Death | General disorders | — |
| Postoperative anemia | Injury, poisoning and procedural complications | — |
| COVID-19 | Infections and infestations | — |
| Cardiac failure | Cardiac disorders | — |
| Femur fracture | Injury, poisoning and procedural complications | — |
| Angina pectoris | Cardiac disorders | — |
| Atrial fibrillation | Cardiac disorders | — |
| Cardiac arrest | Cardiac disorders | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Wrist fracture | Injury, poisoning and procedural complications | — |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | — |
| Multiple fractures | Injury, poisoning and procedural complications | — |
| Hip fracture | Injury, poisoning and procedural complications | — |
| Head injury | Injury, poisoning and procedural complications | — |
| Fracture and Fall | Injury, poisoning and procedural complications | — |
| Disease complication and Peripheral oedema peripheral | General disorders | — |
| Endocarditis | Infections and infestations | — |
| Klebsiella infection | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Cardio-respiratory arrest | Cardiac disorders | — |
| Supraventricular extrasystoles | Cardiac disorders | — |
| Reaction | System | Study Group |
|---|---|---|
| Urinary Infection | Infections and infestations | — |
| Anaemia postoperative | Injury, poisoning and procedural complications | — |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — |
| Renal failure | Renal and urinary disorders | — |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | — |
| Epilepsy | Nervous system disorders | — |
| Metabolic alkalosis | Metabolism and nutrition disorders | — |
| Oedema peripheral | General disorders | — |
| Head injury | Injury, poisoning and procedural complications | — |
| Hip fracture | Injury, poisoning and procedural complications | — |
| Atrial fibrillation | Cardiac disorders | — |
| Delirium | Psychiatric disorders | — |
Most-reported serious reactions: Death, Postoperative anemia, COVID-19, Cardiac failure, Femur fracture, Angina pectoris, Atrial fibrillation, Cardiac arrest.
Data from ClinicalTrials.gov NCT05197335 adverse events section.
This is an observational, prospective and multicenter clinical investigation that is part of the active materiovigilance plan that Orthofix Srl, in agreement with its Notified Body. The sponsor has planned to actively collect clinical data relating to the use of Chimaera Intramedullary Nail in a representative number of users and elderly patients with fractures of the proximal femur. The data obtained from this clinical investigation will be used to complete the pre-market clinical evaluation carried out on the Chimaera with post-market clinical data from the use of the device in normal clinical practice.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing