Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery

NCT ID: NCT06169878

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-11-01

Brief Summary

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This study was conducted to evaluate the effect of the adjustable lower extremity abduction apparatus developed after total hip arthroplasty (TKP) surgeries on preventing dislocation and walking.The study is of randomized controlled type. It was held on the inpatient floor of a Training and Research Hospital in Istanbul, between November 2021 and October 16, 2023, with patients undergoing femoral neck fracture surgery.

All patients who were admitted to this clinic for surgical intervention constituted the population of the study. In the research, 30 patients between the ages of 50-80 were included in the experimental group in which the "Adjustable lower extremity abduction apparatus" developed within the scope of the thesis was used, and 30 patients in which this apparatus was not used were included in the control group. As data collection tools in the study, "Patient Introduction Form", "Standardized Mini Mental State Test", "Patient Mobility Scale", "Modified Barthel Activities of Daily Living Index", "Apparatus Quality and Comfort Assessment Form" " and "Harris Hip Score Form" were used. Data were evaluated using IBM SPPS 27.0 statistical package program.

Detailed Description

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This study aimed to evaluate the effect of an adjustable lower extremity abduction apparatus on the prevention of dislocation, activities of daily life and gait after total hip replacement (THR). The study was a randomised controlled trial. It was conducted on the inpatient floor of a Training and Research Hospital in Istanbul between November 2021 and 16 October 2023 with patients who had femoral neck fracture surgery. All patients admitted to this clinic for surgical intervention constituted the population of the study. In the study, 30 patients aged 50-80 years were included in the intervention group using the adjustable lower extremity abduction apparatus developed within the scope of the thesis, and 30 patients using the pillow in routine practice were included in the control group. Patient Introduction Form, Standardized Mini-Mental State Test, Patient Mobility Scale, Modified Barthel Activities of Daily Living Index, Apparatus Quality and Comfort Assessment Form, and Harris Hip Score Form were used as data collection tools. Data were analysed using the IBM SPPS 27.0 software.

Conditions

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Total Hip Replacement

Keywords

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Total Hip Replacement Adjustable Lower Extremity Abduction Apparatus Gait Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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experimental group

After total hip hip replacement surgery, the abduction apparatus, which provides abduction in the lower extremities and can be adjusted according to the height and weight of the patients, was used while lying and walking.

Group Type EXPERIMENTAL

Adjustable lower limb abduction apparatus

Intervention Type DEVICE

To ensure abduction in the lower extremities after total hip replacement surgery, a specially adjustable apparatus developed according to the height and weight of each individual was used.

This developed product was used by patients while they were lying down and walking.

control group

Pillows routinely used in the field were used to ensure abduction after total hip replacement surgery.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Adjustable lower limb abduction apparatus

To ensure abduction in the lower extremities after total hip replacement surgery, a specially adjustable apparatus developed according to the height and weight of each individual was used.

This developed product was used by patients while they were lying down and walking.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Body mass index \< 35 kg/m²,
* Femoral neck fractures,
* Patients who underwent hip arthroplasty due to femoral neck fracture,
* Those between the ages of 50-80,
* Those who do not have communication barriers,
* Patients without mental and cognitive dysfunction (Standardized mini mental state assessment test score between 24-30),
* Patients who agreed to participate in the study were included in the study

Exclusion Criteria

* Patients who underwent hip arthroplasty due to coxarthrosis in advanced age,
* Those who use equipment as a walking aid before surgery,
* Those whose leg length difference is 3 cm or more,
* Patients who were operated on on one side and those with pathology in their other hips,
* Among patients who were operated on bilaterally, those with one side elevated,
* Those who have additional neuromuscular diseases (Multiple sclerosis, myasthenia gravis etc.),
* Those who have cancer,
* Those who are planned to undergo total hip replacement surgery due to pathological fractures,
* Those with diabetic feet that may prevent walking,
* Those who have previously had total hip replacement surgery,
* Other factors that cause dislocation development (Posterior surgical approach, incorrect position of one or both components, attachment of the femur to the pelvis or residual osteophytes, wedging of the neck of the femoral component to the edge of the acetabular component, insufficient soft tissue tension, size of the incision, inadequate or weak abductor muscle group , major trochanter avulsion or pseudoarthrosis, incompatibility and excessive positioning in the perioperative period, patient education, personal circumstances of the surgeon and the patient) were not included in the scope of the study.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bahçeşehir University

OTHER

Sponsor Role lead

Responsible Party

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Tuğba Türkkan

Nurse

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bahcesehir University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BAHCESEHİRU-TTÜRKKAN-005

Identifier Type: -

Identifier Source: org_study_id