Total Hip ReplacementNCT06169878
Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery
A study testing Adjustable lower limb abduction apparatus in people with Total Hip Replacement, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Total Hip Replacement
- What is being tested?
- Adjustable lower limb abduction apparatus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.),
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery
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.
Read the 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.
- Conditions
- Total Hip Replacement
- Being tested
- Adjustable lower limb abduction apparatus
- Keywords
- Total Hip Replacement, Adjustable Lower Extremity Abduction Apparatus, Gait, Dislocation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjustable lower limb abduction apparatusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
dislocation
Dislocation was determined by the patients electronic records and classified as "yes" or "no" depend on the presence or absence of the status
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Nov 2021
- Primary completion16 Oct 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Türkkan, Bahçeşehir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06169878
- Sponsor's protocol ID
- BAHCESEHİRU-TTÜRKKAN-005
- Status last verified
- Dec 2023
- First submitted
- 25 Nov 2023
- Last updated
- 14 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Adjustable Lower Extremity Abduction Apparatus After Total Hip Replacement Surgery
- ClinicalTrials.gov ID
- NCT06169878
- Acronym / sponsor ID
- BAHCESEHİRU-TTÜRKKAN-005
- Conditions
- Total Hip Replacement
- Keywords
- Total Hip Replacement, Adjustable Lower Extremity Abduction Apparatus, Gait, Dislocation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Adjustable lower limb abduction apparatusAfter 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. |
| control group | No intervention | –Pillows routinely used in the field were used to ensure abduction after total hip replacement surgery. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (11 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adjustable lower limb abduction apparatusTo 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. | Device | experimental group |
Primary outcome
dislocation
Time frame: 4-6 weeks
Dislocation was determined by the patients electronic records and classified as "yes" or "no" depend on the presence or absence of the status
Activities of daily living
Time frame: 4-6 weeks
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.
Gait
Time frame: 4-6 weeks
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.
Length of hospital stay
Time frame: 1-2 weeks
The hospital stay was calculated from the patients hospitalized untill the discharged. The lenght of hospital was calculated as days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adjustable lower limb abduction apparatus in people with Total Hip Replacement, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dislocation (time frame: 4-6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2023.