Femur Intertrochanteric FracturesrandomizedNCT05602155
Partial Weight Bearing Proximal Femoral Nail Due to Intertrochanteric Fracture.
An observational study of Femur Intertrochanteric Fractures, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial summary
Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Femur Intertrochanteric Fractures
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Surgery or procedure
- How many people
- 133 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2018to 30 Aug 2022
- Phase
- Observational
- 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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: 1. Patients over 65 years of age who underwent proximal femoral nail due to femoral intertrochanteric fracture
Who may be able to join
- Patients over 65 years of age with intertrochanteric femoral fractures
- Patients treated with proximal femoral nail
- Patients able to walk before treatment
- Patients who can be contacted
Who cannot join
- Patients without regular follow-up for 1 year
- Patients who do not walk before or after fracture
- who have a neurological disease
- Patients with partial hip replacement after fracture
- Patients who cannot be contacted after treatment
- Patients who died within 1 year after treatment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Duran Topak
Kahramanmaraş, Eyalet/Yerleşke, 46040
About this study
Official title: Comparison of Full-Weight and Partial-Weight-Bearing Patient Groups in Patients Over 65 Years of Age Who Underwent Proximal Femoral Nail Due to Intertrochanteric Fracture of the Femur
Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. After surgical fixation with PFN, patients are mobilized by placing full weight, but some complications can be seen due to the patients being osteoporotic. In this study, the investigators planned to investigate the effect of full weight bearing and partial weight bearing on complications, which were not previously described in the literature.
Read the detailed description
Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates, Barthel Index and harris hip scores in the follow-up of the patients.
- Conditions
- Femur Intertrochanteric Fractures
- Being tested
- Group 1, Group 2
- Keywords
- intertrochanteric fracture, elderly fractures, weight bearing
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Procedure or surgery
Also called partial weight bearing
Even numbered patients will partial weight bearing after treatment,
Group 2Procedure or surgery
Also called full weight bearing
patients with odd numbers will walk with full weight bearing after treatment
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | weight bearing situation: patients with partial weight bearing after treatment Receives: Procedure: Group 1; Procedure: Group 2 | |
| Group 2 | weight bearing: patients with full weight bearing after treatment Receives: Procedure: Group 1; Procedure: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
demographic datas
Descriptive statistical data
Measured: August 2018
comparison of groups
harris hip score: The Turkish version of the Harris hip score with adequate internal consistency (Cronbach's alpha, 0.70) and test-retest reliability (ICC = 0.91) was used for functional outcomes. It is evaluated with scores ranging from 0 to 100. The higher the score, the better the hip function.
Measured: 1 year after surgery
comparison of groups
Barthel Index: The Turkish version of the Barthel index, which was developed by Mahoney and Barthel in 1965, and edited by Küçükdeveci et al., was used to evaluate the degree of independence of patients in activities of daily living. In this scale, where the possible score is between 0-100, the high score means that the patient is independent from other people and can run his own business; 0-20 points are defined as fully dependent, 21-61 points severely dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, and 100 points fully independent
Measured: 6 month after operative treatment
comparison of groups
age (year)
Measured: At the beginning of the study
comparison of groups
Vit D (microgram\L)
Measured: before surgery
comparison of groups
Complication (cut out, Z effect, infection, implant failure)
Measured: august 2022
comparison of groups
Union time (week): Fracture union was defined radiologically as visible callus formation and reduction in pain in the groin.
Measured: On completion of the study, an average of 1 year
comparison of groups
Following time (month): The time elapsed between the date the patient came for the last control and the first application
Measured: patient's last control date, at least 1 year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Aug 2018
- Primary completion30 Mar 2021
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Femur Intertrochanteric FracturesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duran Topak, Kahramanmaras Sutcu Imam University
- Investigators
- Ökkeş Bilal, 3., Study chair, Assistant researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602155
- Sponsor's protocol ID
- 13.07.2018\16
- Acronym
- randomized
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates and harris hip scores in the follow-up of the patients.
Publications
Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
PubMed 10853723Jensen JS. Classification of trochanteric fractures. Acta Orthop Scand. 1980 Oct;51(5):803-10. doi: 10.3109/17453678008990877.
PubMed 7468173
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Full-Weight and Partial-Weight-Bearing Patient Groups in Patients Over 65 Years of Age Who Underwent Proximal Femoral Nail Due to Intertrochanteric Fracture of the Femur
- ClinicalTrials.gov ID
- NCT05602155
- Acronym / sponsor ID
- randomized / 13.07.2018\16
- Conditions
- Femur Intertrochanteric Fractures
- Keywords
- intertrochanteric fracture, elderly fractures, weight bearing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 1 Nov 2022 (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.
Femur intertrochanteric fractures (FITC) are one of the most common fractures of the lower extremity, caused by osteoporosis, caused by minor trauma in elderly patients. Today, it is successfully treated with proximal femoral nails (PFN) designed in different ways. After surgical fixation with PFN, patients are mobilized by placing full weight, but some complications can be seen due to the patients being osteoporotic. In this study, the investigators planned to investigate the effect of full weight bearing and partial weight bearing on complications, which were not previously described in the literature.
Detailed description
Participants over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates, Barthel Index and harris hip scores in the follow-up of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Group 1, Procedure: Group 2weight bearing situation: patients with partial weight bearing after treatment |
| Group 2 | – | Procedure: Group 1, Procedure: Group 2weight bearing: patients with full weight bearing after treatment |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 1. Patients over 65 years of age who underwent proximal femoral nail due to femoral intertrochanteric fracture
Key inclusion criteria (4 listed)
- Patients over 65 years of age with intertrochanteric femoral fractures
- Patients treated with proximal femoral nail
- Patients able to walk before treatment
- Patients who can be contacted
Key exclusion criteria (6 listed)
- Patients without regular follow-up for 1 year
- Patients who do not walk before or after fracture
- who have a neurological disease
- Patients with partial hip replacement after fracture
- Patients who cannot be contacted after treatment
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 |
|---|---|---|
| Group 1Also: partial weight bearingEven numbered patients will partial weight bearing after treatment, | Procedure or surgery | Group 1, Group 2 |
| Group 2Also: full weight bearingpatients with odd numbers will walk with full weight bearing after treatment | Procedure or surgery | Group 1, Group 2 |
Primary outcome
demographic datas
Time frame: August 2018
Descriptive statistical data
comparison of groups
Time frame: 1 year after surgery
harris hip score: The Turkish version of the Harris hip score with adequate internal consistency (Cronbach's alpha, 0.70) and test-retest reliability (ICC = 0.91) was used for functional outcomes. It is evaluated with scores ranging from 0 to 100. The higher the score, the better the hip function.
comparison of groups
Time frame: 6 month after operative treatment
Barthel Index: The Turkish version of the Barthel index, which was developed by Mahoney and Barthel in 1965, and edited by Küçükdeveci et al., was used to evaluate the degree of independence of patients in activities of daily living. In this scale, where the possible score is between 0-100, the high score means that the patient is independent from other people and can run his own business; 0-20 points are defined as fully dependent, 21-61 points severely dependent, 62-90 points moderately dependent, 91-99 points mildly dependent, and 100 points fully independent
comparison of groups
Time frame: At the beginning of the study
age (year)
comparison of groups
Time frame: before surgery
Vit D (microgram\L)
comparison of groups
Time frame: august 2022
Complication (cut out, Z effect, infection, implant failure)
comparison of groups
Time frame: On completion of the study, an average of 1 year
Union time (week): Fracture union was defined radiologically as visible callus formation and reduction in pain in the groin.
comparison of groups
Time frame: patient's last control date, at least 1 year later
Following time (month): The time elapsed between the date the patient came for the last control and the first application
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 2 Nov 2022.
- Results publication: PubMed 10853723Kucukdeveci AA, Yavuzer G, Tennant A, Suldur N, Sonel B, Arasil T. Adaptation of the modified Barthel Index for use in physical medicine and rehabilitation in Turkey. Scand J Rehabil Med. 2000 Jun;32(2):87-92.
- Results publication: PubMed 7468173Jensen JS. Classification of trochanteric fractures. Acta Orthop Scand. 1980 Oct;51(5):803-10. doi: 10.3109/17453678008990877.
- Barthel indexLink provided by the sponsor.
- Fracture classificationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patients over the age of 60 who underwent PFN with the diagnosis of FITK were randomized (double-blinded consecutive full load on one patient and partial weight on one patient), and mobilized a group with full weight with the help of a walker after surgical fixation, and the other group with the help of a walker to give partial weight (balance). We planned to follow up his treatment prospectively. The compatibility of the groups will be evaluated by comparing the bone mineral density, calcium, alkaline phosphatase, phosphate, vitamin D levels and ages of the patients. Fracture types and post-treatment reduction quality of patients in both groups will be compared. We planned to compare the complication rates and harris hip scores in the follow-up of the patients.
Related trials for Femur Intertrochanteric Fractures
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
RecruitingObservational study
Cohort Study on the Prognosis and Influencing Factors in Elderly Patients With Hip Fractures in Multicenter of China
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Recruiting
Influence of Cemented Cephalic Augmentation on the Outcome of Intramedullary Nailing in Pertrochanteric Hip Fractures
Hip Fracture of Intertrochanteric Type
Not yet recruiting
FICB for Hip Fracture Pain in Elderly
Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures), Postoperative Pain
Recruiting
Robot-Assisted Closed Reduction and Internal Fixation for Intertrochanteric Femoral Fractures
Intertrochanteric Fractures, Intertrochanteric Fractures of the Hip
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.
Ökkeş Bilal, 3. study chair
Assistant researcher
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Intertrochanteric Fractures, run by Kahramanmaras Sutcu Imam 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 4 inclusion and 6 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 2 Nov 2022. 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?
demographic datas (time frame: August 2018). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05602155, which also lists 2 linked publications.
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 2 Nov 2022.