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

February 8, 2018 updated by: Tiemiao Yu, Harrison International Peace Hospital

Efficacy and Safety of Cemented and Cementless Prostheses in the Repair of Unstable Intertrochanteric Fractures in the Elderly: a Prospective, Single-center, Non-randomized, Controlled, Clinical Trial With 6-month Follow-up

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Background Intertrochanteric fractures are common types of hip fractures. With the growth of the global aging population, the elderly fracture patients with osteoporosis are increasing. Thus, the difficulty of treating intertrochanteric fractures increases accordingly. Unstable intertrochanteric fractures refer to the fractures from femoral neck base to lesser trochanter level. With the continuous development of China's aging trend, the number of aging population is increasing gradually; the incidence of unstable intertrochanteric fractures is increasing year by year. Clinically, more than 90% of intertrochanteric fractures occur in the elderly over 65 years of age, and the mortality rate is at a high level. Patients with unstable intertrochanteric fractures are older, and body function gradually degrades. The reduction and fixation of this disease are difficult. Therefore, early to find timely and effective treatment is of great significance to patients with unstable intertrochanteric fractures.

Clinically, internal fixation and artificial joint replacement are the primary methods of treating unstable intertrochanteric fractures. The surgical approach of internal fixation is easily affected by the bone quality of the patients. If the patient has different degrees of osteoporosis, it will lead to the failure of the first operation, affecting the prognosis of the patient. Therefore, this kind of operation method is not accepted gradually in clinical practice. The efficacy of joint replacement for treatment of intertrochanteric fracture is remarkable. It can make the patient obtain the immediate stability and reduce complications, so it is very popular with the patients and physicians in the clinic. The most commonly used artificial joint replacement materials in clinic have two types: cemented and cementless prostheses, but the difference in their efficacies and safeties remains poorly understood.

Adverse events To record adverse events, including incision pain, bone cement poisoning, pulmonary infection, mental disorders and acute cerebral infarction.

If severe adverse events occurred, investigators reported details, including the date of occurrence and measures taken to treat the adverse events, to the principle investigator and the institutional review board within 24 hours.

Data collection, management, analysis and open-access Data collection: Records of all cases reported in the trial were complete, clear and true. The case reports were consistent with the patient's original data and the declared data. The collected data were input to the computer in the record room of Harrison International Peace Hospital.

Data management: Data were processed by a special person, and aggregated once a month. During clinical trials, hospital clinic visits were conducted periodically by the clinical ombudsman to ensure that all the contents of the protocols were strictly observed. Simultaneously, raw data were checked to ensure the consistency with the case report form.

Data analysis: Statistical analysis was performed by professional statisticians. The statisticians wrote the research report and submitted it to the researcher for review.

Data open-access: Anonymized trial data will be published at www.figshare.com.

Statistical analysis Statistical analysis was performed using SPSS 19.0 software (IBM, Armonk, NY, USA) and followed the intention-to-treat principle.

Normally distributed measurement data were expressed as means ± standard deviation and minimums and maximums. Non-normally distributed measurement data were expressed as the lower quartile (q1) and median and upper quartiles (q3). Count data were expressed as the percentage. Two-sample t-test was performed for comparison of Harris hip scores, operation time, intraoperative blood loss, postoperative blood transfusion volume, ambulation time and postoperative amount of drainage in both groups. Repeated measures analysis of variance was conducted for intragroup comparison of Harris hip scores at various time points. Pearson X2 test was carried out for comparison of excellent and good rate of Harris hip scores and incidence of adverse reaction in both groups.

The significance level was α = 0.05.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: control group
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
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).
Other Names:
  • control group
EXPERIMENTAL: trial group
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
Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).
Other Names:
  • trial group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Harris hip scores
Time Frame: at postoperative 6 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
X-ray
Time Frame: Changes from preoperative 6 months to postoperative 6 months
To observe morphological changes in the hip.Morphology of the hip was observed in the anteroposterior and lateral images. Heterotopic ossification was classified via the Brooker classification system.
Changes from preoperative 6 months to postoperative 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Harrison International Peace Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 19, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 21, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HarrisonIPH_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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