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Prospective, multicenter, randomized controlled clinical study of a novel sliding compression locking plate in the treatment of fresh femoral neck fractures

Prospective, multicenter, randomized controlled clinical study of a novel sliding compression locking plate in the treatment of fresh femoral neck fractures

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092302
Enrollment
Unknown
Registered
2024-11-14
Start date
2024-11-18
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fracture of neck of femur

Interventions

sliding compression locking plate group:Patients with femoral neck fracture were treated with sliding compression locking plate internal fixation
three cannulated compression screws group:The patients with femoral neck fracture were treated with three cannulated compression screws

Sponsors

The First Medical Center of Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age >=18 years old, gender is not limited; (2) Patients diagnosed with femoral neck fracture; (3) Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery; (4) The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion criteria

Exclusion criteria: (1) Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit; (2) The patient is known to have a history of allergy to one or more implanted materials; (3) Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases; (4) Active infection of the hip joint or other parts of the body is determined by the investigator; (5) Diagnosed as metabolic bone disease, radiation bone disease, etc.; (6) Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain; (7) have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.; (8) The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate; (9) Other conditions deemed unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Femoral neck shortened;

Secondary

MeasureTime frame
Neck shaft angle;Guide needle implantation effect;time of operation;blood loss;bone union;Zarit nursing score;Harris Score;SF-36 Score;

Countries

China

Contacts

Public ContactWei Zhang

Chinese PLA General Hosptial

bszw@hotmail.com+86 186 1240 9252

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026