Feasibility of Implantation of Cemented Femoral Stem for Osteoporotic Femoral Neck Fracture in Elderly Patients

NCT02901938 | Unknown DMC

• 1 other identifier: QinghaiUH_004
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will investigate the effects of implantation of cemented femoral stem versus percutanous internal fixation with cannulated compression screws on hip joint function recovery, pains, femoral head collapse and sterile prosthesis loosening, peri-prosthesis infection, and the histocompatibility of prosthesis material with host tissue in the elderly patients with osteoporotic fracture of proximal femoral neck complicated by avascular necrosis of the femoral head, which will provide scientific evidence for selecting surgical methods and internal fixation/artificial prosthesis material for osteoporotic fracture of proximal femoral neck in the elderly patients.

Conditions

Femoral Neck Fracture

Outcome Measures

Primary Outcomes (1)

• Changes of Harris hip scores

  To evaluate the recovery of hip joint function from the domains covering pain, function, absence of deformity, and range of motion, with higher scores indicating better hip joint function. Hip joint function is scored as follows: ≥ 90 is excellent, 80-89 very good, 70-79 good, and \< 70 poor.

  at baseline, 1, 6 and 12 months after surgery

Secondary Outcomes (1)

• Changes of VAS scores

  at baseline, 1, 6 and 12 months after surgery

Study Arms (2)

cemented femoral stem group

EXPERIMENTAL

The patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to undergo implantation of cemented femoral stem.

Procedure: cemented femoral stem

cannulated compression screws group

EXPERIMENTAL

The patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to undergo percutaneous internal fixation with cannulated compression screws.

Device: cannulated compression screws

Interventions

cemented femoral stem PROCEDURE

The patients assigned even numbers will undergo implantation of cemented femoral stem.

cemented femoral stem group

cannulated compression screws DEVICE

The patients assigned even numbers will undergo percutaneous internal fixation with cannulated compression screws.

cannulated compression screws group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with avascular necrosis of the femoral head diagnosed according to the previous criteria: Bone nonunion as indicated by a clear fracture line on X-ray images 12 months after femoral neck fracture; cystic degeneration, sclerosis, and uneven density on X-ray images and CT scans
• Patients with osteoporosis diagnosed according to a previous report: Bone density T value \< -2.5 or bone mass decrease by 25%
• Patients with femoral neck fracture diagnosed according to the previous criteria (Chen and Wang, 2013): Presence of a fracture line on anterior- posterior X-ray images of the hip joint, and CT and MRI examination in combination with clinical symptoms and physical sign are necessary if no fracture line appears
• Age 60-80 years
• Healthy and able to tolerate anesthesia and surgery
• Provision of informed consent about participation and trial procedure

You may not qualify if:

• Alcohol abuse or long-term use of hormone drugs
• Infection of tissue around the hip joint
• Bone metabolism disorders other than osteoporosis, such as renal osteodystrophy and osteomalacia
• Heart, lung, brain, or other systemic diseases
• Advanced malignant tumor
• Recent cerebral hemorrhage, myocardial infarction, or failure of important organs
• Injured limb with deep venous thrombosis
• Inability to tolerate surgery

Sponsors & Collaborators

• Qinghai University: lead

MeSH Terms

Conditions

Femoral Neck Fractures

Condition Hierarchy (Ancestors)

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

Study Officials

• Rong Ren, Master

  Affiliated Hospital of Qinghai University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 15, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2018
• Last Updated: September 15, 2016

Record last verified: 2016-09