Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

Prospective, Multicenter, Randomized Controlled Clinical Study of Medial Enhancement Technique for the Treatment of Old Femoral Neck Fractures

A prospective, multi-center, randomized controlled study was conducted to validate the safety and effectiveness of employing the medial augmentation technique (incorporating the dynamic condylar screw and medial support plate) supplemented with bone grafting for the treatment of old femoral neck fractures.

Study Overview

• Status: Not yet recruiting
• Conditions: Fracture of Neck of Femur
• Intervention / Treatment: Procedure: cannulated compression screws + iliac bone graft; Procedure: DCS + medial support plate + iliac bone graft

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Zhang; Phone Number: +8612409252; Email: bszw@hotmail.com

Study Locations

• China
  • Beijing, China
    • Chinese PLA General Hosptial

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age >= 18 years, gender not specified;
2. Patients with femoral neck fractures who have not undergone surgery for more than 3 weeks, or patients with persistent non-union following internal fixation of femoral neck fractures;
3. Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
4. Participants or their legal representatives are informed about the nature of this study and agree to participate.

Exclusion Criteria:

1. Participants who have not reached the primary endpoint of other drug, biological agent, or medical device clinical trials prior to enrollment;
2. Known history of hypersensitivity to one or more implanted materials by the patient;
3. Judged by the investigator as physically frail or unable to tolerate surgery due to other systemic diseases;
4. Active infectious foci in the hip joint or other parts of the body, as judged by the investigator;
5. Diagnosed with metabolic bone disease, radiation-induced bone disease, etc.;
6. Severe hip contracture deformity or severe muscle weakness that has been immobilized in functional position for a long time and painless;
7. Suffering from inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. Patients who lack the mental capacity or understanding to meet the requirements of participating in the study, or are difficult to cooperate with;
9. Other situations where the investigator deems the participant unsuitable for inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Cannulated compression screws + iliac bone graft group	Procedure: cannulated compression screws + iliac bone graft; Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures
Experimental: DCS + medial support plate + iliac bone graft group	Procedure: DCS + medial support plate + iliac bone graft; Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fracture healing rate	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral head necrosis	Commonly used imaging tools include X-rays, Magnetic Resonance Imaging (MRI), and Computerized Tomography (CT). X-rays are the most commonly employed assessment tool, capable of displaying the morphology of the femoral head and whether the bone structure is normal. MRI and CT can provide more detailed images, aiding in the determination of the extent and range of femoral head necrosis.	1 year
Harris score	The Harris Score (Harris Hip Score, HHS) is a widely used scale for evaluating hip joint function and patient quality of life, often applied to assess the outcomes of hip replacement surgery or other treatments for hip joint diseases. It covers four main aspects: pain level, functional activity, joint range of motion, and hip joint deformity. The total score ranges from 0 to 100, with 100 being the best possible condition, indicating complete normalcy of hip joint function.	1 year
VAS score	The VAS score (Visual Analog Scale) is a commonly used tool for quantifying pain assessment that is suitable for measuring various degrees of pain. The VAS score typically employs a straight line 10 centimeters long (or an equivalent visual scale), with each end marked as "No Pain" and "Most Intense Pain" respectively. A straight line 10 centimeters long (or an equivalent visual scale) is often utilized, with each end labeled as "No Pain" and "Most Intense Pain."	1 year
Complications	Focusing on perioperative complications in patients, indications and symptoms of incision infection, including redness, swelling, drainage, and fever, should be carefully monitored. The incidence and severity of infection cases should be recorded and analyzed to evaluate the risk factors for postoperative infection and the effectiveness of preventive strategies. Unplanned reoperations should be recorded, including cases of primary surgery failure, development of complications, or other situations necessitating further surgical intervention. Detailed records of the causes, timing, and outcomes of reoperations will help evaluate the reliability of surgical techniques and internal fixation devices. Additionally, other postoperative complications, such as femoral head necrosis, repositioning of fracture ends, fixation loosening and breakage, should be meticulously recorded and observed.	1 year

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: November 16, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: cannulated compression screws with iliac bone graft; Medial enhancement technique with iliac bone graft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Hip Fractures; Fractures, Bone; Femoral Neck Fractures
• Other Study ID Numbers: S2024-342-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No