NCT06713031

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
6mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2024Oct 2026

First Submitted

Initial submission to the registry

November 16, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 3, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

December 10, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2026

Expected
Last Updated

December 4, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

November 16, 2024

Last Update Submit

December 3, 2024

Conditions

Fracture of Neck of Femur

Keywords

cannulated compression screws with iliac bone graftMedial enhancement technique with iliac bone graft

Outcome Measures

Primary Outcomes (1)

  • Fracture healing rate

    1 year

Secondary Outcomes (4)

  • Femoral head necrosis

    1 year

  • Harris score

    1 year

  • VAS score

    1 year

  • Complications

    1 year

Study Arms (2)

Cannulated compression screws + iliac bone graft group

PLACEBO COMPARATOR
Procedure: cannulated compression screws + iliac bone graft

DCS + medial support plate + iliac bone graft group

EXPERIMENTAL
Procedure: DCS + medial support plate + iliac bone graft

Interventions

cannulated compression screws + iliac bone graftPROCEDURE

Using "cannulated compression screws + iliac bone graft" technique to treat old femoral neck fractures

Cannulated compression screws + iliac bone graft group
DCS + medial support plate + iliac bone graftPROCEDURE

Using "DCS + medial support plate + iliac bone graft" technique to treat old femoral neck fractures

DCS + medial support plate + iliac bone graft group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 18 years, gender not specified;
  • 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;
  • Have indications for internal fixation surgery for femoral neck fractures and are able to tolerate the surgery;
  • Participants or their legal representatives are informed about the nature of this study and agree to participate.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hosptial

Beijing, China

Location

MeSH Terms

Conditions

Femoral Neck Fractures

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

Hip FracturesFemoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsOxazolidinonesOxazolesSerineAmino Acids, NeutralAmino AcidsAmino Acids, Peptides, and Proteins

Central Study Contacts

Wei Zhang

CONTACT

+8612409252bszw@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy head of orthopedics

Study Record Dates

First Submitted

November 16, 2024

First Posted

December 3, 2024

Study Start

December 10, 2024

Primary Completion

December 10, 2024

Study Completion (Estimated)

October 31, 2026

Last Updated

December 4, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)