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

NCT06169878 | Completed

• 1 other identifier: BAHCESEHİRU-TTÜRKKAN-005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Hip Replacement

Keywords

Total Hip Replacement; Adjustable Lower Extremity Abduction Apparatus; Gait; Dislocation

Outcome Measures

Primary Outcomes (4)

• dislocation

  Dislocation was determined by the patients electronic records and classified as "yes" or "no" depend on the presence or absence of the status

  4-6 weeks

• Activities of daily living

  Daily living activities was assessed by using modified barthel actirivites of daily living index The modified Barthel Activities of Daily Living Index (MBGADLI) was developed by Barthel and Mahoney in 1965. Küçükdeveci et al. conducted a validity and reliability study of the index for the Turkish society with neurological patients in 2000. The Modified Barthel Index is an unbiased, easy-to-apply, understandable and causal relationship scale. The scores of the Modified Barthel Index for Activities of Daily Living range from 0 to 100. Higher scores indicate a greater level of independence.

  4-6 weeks

• Gait

  Harris Hip Score was used to assess the patients gait Harris Hip Score (HHS): The Harris Hip Score, developed by W.H. Harris in 1969, evaluates patients who have undergone total hip replacement. Çelik et al. (2014) reported that the Turkish version of the Harris Hip Score is reliable and valid. The Harris hip score scale is composed of ten items and divided into four sub-scales: pain, function, absence of deformity, and range of motion. It is scored between 0 and 100 points. The criteria for evaluation are as follows: A score of less than 70 is considered poor, 70 to 80 is fair, 80 to 90 is good, and a score between 90 and 100 is excellent. To measure the range of motion sub-step of the Harris hip score, a universal goniometer was utilized in the investigation.

  4-6 weeks

• Length of hospital stay

  The hospital stay was calculated from the patients hospitalized untill the discharged. The lenght of hospital was calculated as days.

  1-2 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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.

Device: Adjustable lower limb abduction apparatus

control group

NO INTERVENTION

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

Interventions

Adjustable lower limb abduction apparatus 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.

experimental group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bahçeşehir University: lead

Study Sites (1)

Bahcesehir University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 14, 2023
• Study Start: November 1, 2021
• Primary Completion: October 16, 2023
• Study Completion: November 1, 2023
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)