Neck of Femur FractureNCT05587660
Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
A study testing Fully threaded cannulated screws in people with Neck of Femur Fracture, run by Nishtar Medical University at 1 site in Pakistan.
Trial summary
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Neck of Femur Fracture
- What is being tested?
- Fully threaded cannulated screws
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2021to 30 Jul 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of garden type I or II fractures.
- All patients to be mobile before femoral neck fracture.
Who cannot join
- Patients having open fracture.
- Patients with present or past history of chronic kidney disorder.
- Patients presenting with hemorrhage.
- Patient with nervous stroke
- Patients unwilling to be part of this study.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Nishtar Medical University Hospital
Multan Khurd, Punjab Province, 63100
About this study
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.
Read the detailed description
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.
- Conditions
- Neck of Femur Fracture
- Being tested
- Fully threaded cannulated screws
- Keywords
- Cannulated screw, fracture, Hip Harris score
- Medical subject headings
- Femoral Neck Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fully threaded cannulated screwsProcedure or surgery
The most popular method in undisplaced neck of femur fracture include internal fixation by cannulated screws in which screws can be inserted relatively simply and atraumatically as compared to other methods. Screws can be used partially threaded or fully threaded; however studies on fully threaded screw fixation method are inconclusive.
| Study group | Role | What they receive |
|---|---|---|
| Partially threaded cannulated screw fixation | Experimental | In Group-A patients, cannulated screw fixation was done using partially threaded screws. In this procedure, first step was insertion of three guide wires under image. The 1st guide wire was inserted immediately above calcar and into femoral head. The second wire was placed posteriorly adjacent to posterior cortex of neck on lateral view. Finally, third guide wire was placed anteriorly and superiorly. Drilling of lateral cortex was done before insertion of screws. Then partially threaded screw fixation was done before removal of guide wires using washers. Receives: Procedure: Fully threaded cannulated screws |
| Fully threaded cannulated screws fixation | Experimental | The surgical approach in fully thread cannulated screws fixation group will remain same but instead of partially threaded screwsm fully threaded screws to be used in this group. Receives: Procedure: Fully threaded cannulated screws |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harris Hip Score (RUSH SCORE)
Harris Hip Score (RUSH SCORE) is the method to assess the result of hip surgery and is intended to evaluate various hip disabilities and methods of treatment. RUSH Score was calculated with "Rradiographic Union Score for Hip (RUSH)", designed to improve intra-and inter-observer reliability when describing the radiographic healing.
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jul 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neck of Femur FractureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Randomization to be done through lottery method and then the allocation to be made in both study groups.
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nishtar Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rashida Parveen, Nishtar Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587660
- Sponsor's protocol ID
- NishtarMU123
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Awais MZ, Salik E, Bokhari SHR, Iqbal MT. A comparative study of early functional outcomes in undisplaced neck of femur fracture treated with partially threaded and fully threaded cannulated screw fixation in patients above 60 years age. Pak J Med Sci. 2023 Sep-Oct;39(5):1531-1534. doi: 10.12669/pjms.39.5.7330.
PubMed 37680815
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Functional Outcomes in Unisplaced Neck of Femur Fracture Treated With Partially Threaded and Fully Threaded Cannulated Screw Fixation in Patients of Age 60 and Above
- ClinicalTrials.gov ID
- NCT05587660
- Acronym / sponsor ID
- NishtarMU123
- Conditions
- Neck of Femur Fracture
- Keywords
- Cannulated screw, fracture, Hip Harris score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Nishtar Medical UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 20 Oct 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.
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. A total of 82 (41 in each group) patients of both genders, aged 60 or above. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score to be used to evaluate fracture healing.
Detailed description
This study is done to compare the partially threaded versus fully threaded cannulated screw fixation methods in stable neck of femur fracture in terms of early functional outcomes in patients of age 60 and above. This is a randomized controlled trial where a total of 82 (41 in each group) patients of both genders, aged 60 or above. All these patients had garden type I or II and were mobile before femoral neck fracture were included. In Group-A patients cannulated screw fixation was done using partially threaded screws and in Group-B patients were treated with fully threaded screws were used. Patients were treated according to following schedule and were followed up at 6 weeks, 3 months and 6 months interval. The Radiographic Union Scale for Hip (RUSH) and Harris Hip score were used to evaluate fracture healing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization to be done through lottery method and then the allocation to be made in both study groups.
| Arm | Type | Receives |
|---|---|---|
| Partially threaded cannulated screw fixation | Experimental | Procedure: Fully threaded cannulated screwsIn Group-A patients, cannulated screw fixation was done using partially threaded screws. In this procedure, first step was insertion of three guide wires under image. The 1st guide wire was inserted immediately above calcar and into femoral head. The second wire was placed posteriorly adjacent to posterior cortex of neck on lateral view. Finally, third guide wire was placed anteriorly and superiorly. Drilling of lateral cortex was done before insertion of screws. Then partially threaded screw fixation was done before removal of guide wires using washers. |
| Fully threaded cannulated screws fixation | Experimental | Procedure: Fully threaded cannulated screwsThe surgical approach in fully thread cannulated screws fixation group will remain same but instead of partially threaded screwsm fully threaded screws to be used in this group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of garden type I or II fractures.
- All patients to be mobile before femoral neck fracture.
Key exclusion criteria (5 listed)
- Patients having open fracture.
- Patients with present or past history of chronic kidney disorder.
- Patients presenting with hemorrhage.
- Patient with nervous stroke
- Patients unwilling to be part of this study.
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 |
|---|---|---|
| Fully threaded cannulated screwsThe most popular method in undisplaced neck of femur fracture include internal fixation by cannulated screws in which screws can be inserted relatively simply and atraumatically as compared to other methods. Screws can be used partially threaded or fully threaded; however studies on fully threaded screw fixation method are inconclusive. | Procedure or surgery | Fully threaded cannulated screws fixation, Partially threaded cannulated screw fixation |
Primary outcome
Harris Hip Score (RUSH SCORE)
Time frame: 6-months
Harris Hip Score (RUSH SCORE) is the method to assess the result of hip surgery and is intended to evaluate various hip disabilities and methods of treatment. RUSH Score was calculated with "Rradiographic Union Score for Hip (RUSH)", designed to improve intra-and inter-observer reliability when describing the radiographic healing.
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 20 Oct 2022.
- Derived from this study: PubMed 37680815Awais MZ, Salik E, Bokhari SHR, Iqbal MT. A comparative study of early functional outcomes in undisplaced neck of femur fracture treated with partially threaded and fully threaded cannulated screw fixation in patients above 60 years age. Pak J Med Sci. 2023 Sep-Oct;39(5):1531-1534. doi: 10.12669/pjms.39.5.7330.
- Individual participant dataSharing planned: Undecided
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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 Fully threaded cannulated screws in people with Neck of Femur Fracture, run by Nishtar Medical University at 1 site in Pakistan.
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 2 inclusion and 5 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 20 Oct 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 Pakistan. 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?
Harris Hip Score (RUSH SCORE) (time frame: 6-months). 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 NCT05587660, which also lists 1 linked publication.
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 20 Oct 2022.