Safety and Effectiveness of Proximal Femoral Nail Antirotation for the Treatment of Intertrochanteric Femoral Fracture

NCT02880501 | Unknown DMC

• 1 other identifier: ChaohuH_001
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Minimally invasive PFNA fixation for the treatment of intertrochanteric femoral fracture will be used in 20 patients within 2 years to objectively validate the safety and effectiveness of PFNA in the treatment of fracture of long tube-like bone.

Conditions

Intertrochanteric Femoral Fracture

Outcome Measures

Primary Outcomes (1)

• Complications

  pains on the affected region, wound nonunion, incision infection

  6 months after surgery

Secondary Outcomes (4)

• Fracture healing

  baseline, at 3 and 6 months after surgery

• Hip joint function

  baseline, at 3 and 6 months after surgery

• Patient's quality of life

  baseline, at 3 and 6 months after surgery

• Barthel Index of Activities of Daily Living (Barthel ADL Index)

  baseline, at 3 and 6 months after surgery

Study Arms (1)

proximal femoral nail antirotation

EXPERIMENTAL

Twenty patients with intertrochanteric femoral fracture scheduled will undergo proximal femoral nail antirotation (PFNA) implantation.

Device: proximal femoral nail antirotation

Interventions

proximal femoral nail antirotation DEVICE

Twenty patients with intertrochanteric femoral fracture scheduled to undergo proximal femoral nail antirotation (PFNA) implantation.

proximal femoral nail antirotation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intertrochanteric femoral fracture diagnosed by anterior-posterior and lateral X-ray images, CT and MRI scans
• Types II-IV intertrochanteric femoral fracture in Evans-Jensen classification (Fung et al., 2007)
• Osteoporosis-caused intertrochanteric femoral fracture
• Fresh closed fracture (surgery performed within 2 weeks after fracture)
• Surgery performed for the first time after fracture
• Healthy and able to tolerance to anesthesia and surgery
• Age \>18 years
• Provision of informed consent about participation and trial procedure

You may not qualify if:

• Not suitable to undergo internal fixation (such as severe osteoarthritis, rheumatoid arthritis and pathological fracture)
• Has installed other auxiliary devices in injured hip joint
• Infection of tissue around the hip joint
• With bone metabolism disorders besides osteoporosis, such as renal osteodystrophy and osteomalacia
• With heart, lung, brain and other systemic diseases
• With advanced malignant tumor
• Recently suffering from cerebral hemorrhage, myocardial infarction, and failure of important organs which are difficult to be corrected
• With injured limb deep venous thrombosis
• With mental disorders
• Unable to tolerance to surgery

Sponsors & Collaborators

• Chaohu Hospital of Anhui Medical University: lead

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Officials

• Junjie Xu, MD

  Chaohu Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 26, 2016
• Study Start: January 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 26, 2016

Record last verified: 2016-08