Efficacy and Safety of Cemented and Cementless Prostheses for Unstable Intertrochanteric Fractures in the Elderly

NCT03193697 | Completed DMC

• 1 other identifier: HarrisonIPH_01
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief Summary

This trial explores the application of different hip replacement materials in elderly patients with unstable intertrochanteric fracture, and aims to provide the experience and basis for hip arthroplasty in elderly osteoporosis patients with unstable intertrochanteric fracture.

Conditions

Intertrochanteric Fractures

Outcome Measures

Primary Outcomes (1)

• Harris hip scores

  To assess the recovery of hip function.The number of patients with excellent and good Harris hip scores/total number of patients × 100%. High excellent and good rate indicates good hip function.

  at postoperative 6 months

Secondary Outcomes (1)

• X-ray

  Changes from preoperative 6 months to postoperative 6 months

Study Arms (2)

control group

EXPERIMENTAL

Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).

Device: cemented SPII prosthesis

trial group

EXPERIMENTAL

Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).

Device: cementless Wagner prosthesis

Interventions

cemented SPII prosthesis DEVICE

Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).

Also known as: control group

control group

cementless Wagner prosthesis DEVICE

Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).

Also known as: trial group

trial group

Eligibility Criteria

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

You may qualify if:

• Unstable intertrochanteric fractures identified by imaging and laboratory examination
• Age: Greater than 65 years old
• Irrespective of sex
• Volunteered to participate in this test, and signed informed consent

You may not qualify if:

• Replacement contraindications, such as acute myocardial infarction
• Obvious obstacles in language communication and communication

Sponsors & Collaborators

• Harrison International Peace Hospital: lead

MeSH Terms

Conditions

Hip Fractures

Interventions

Control Groups

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

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

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2017
• Last Updated: February 12, 2018

Record last verified: 2018-02