Clinical trial NCT06169878: Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery
Official title: Evaluation of the Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Hip Replacement
Keywords: Total Hip Replacement
Adjustable Lower Extremity Abduction Apparatus
Gait
Dislocation
Lead sponsor: Bahçeşehir University
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: dislocation
timeFrame: 4-6 weeks
measure: Activities of daily living
timeFrame: 4-6 weeks
measure: Gait
timeFrame: 4-6 weeks
measure: Length of hospital stay
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahcesehir University
Study officials:
References: