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Osteoarthritis, HipFluoroscopyNCT02706002

Fluoroscopy Improves Femoral Stem Placement

A study testing fluoroscopy and hip prosthesis in people with Osteoarthritis, Hip, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality. Because conventional templating has a high mismatch rate, the investigators sought to explore whether the investigators could use intraoperative fluoroscopy while implanting the femoral stem. Read more about this study

Who is it for?
Any age
Conditions the study is for
Osteoarthritis, Hip
What is being tested?
fluoroscopy and hip prosthesis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
No sites listed yet
Study dates
Nov 2015to Feb 2016
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • patients with hip osteoarthritis

Who cannot join

  • malignant tumors, previously known bone disease, drug consumption affecting bone mineralization or Crowe type III hip dislocations with greater than 4 cm of LLD were excluded

About this study

Official title: Fluoroscopy Improves Femoral Stem Placement in Cementless Total Hip Arthroplasty

Fluoroscopy is routinely used in trauma cases to evaluate alignment and reduction quality. Because conventional templating has a high mismatch rate, the investigators sought to explore whether the investigators could use intraoperative fluoroscopy while implanting the femoral stem.

Read the detailed description

Prospectively two groups of patients with hip osteoarthritis were included in the study. Hip osteoarthritis was classified according to the Croft classification. The investigators primary goal is to evaluate T+ 2 ( 2 cm above trochanter minor) results between the two groups. Standard effect sizes (standard effect size) assumed to be at least 0.75. 30 cases for each group took power with 80% margin of 5% error. Patients with malignant tumors, previously known bone disease, drug consumption affecting bone mineralization or Crowe type III hip dislocations with greater than 4 cm of limb length discrepancy (LLD) were excluded. Prior to the operation, all patients underwent an X ray investigation to exclude any bone abnormalities. All patients were operated by the same team, which was composed of two senior surgeons and 2 fellows. Patients with odd-numbered were the first group and even numbers were the second group in order of receipt surgery. All patients were operated on the lateral decubitus position with a posterior approach and a metaphyseal locking femoral stem (Depuy Synthess SUMMIT Tapered Hip System, US). In the first group, no preoperative templating was performed, and the final conformation of the stem size and position was decided freehand intraoperatively based on anatomic landmarks. In the second group, there was also no preoperative templating, but after both senior surgeons agreed on the final stem size intraoperatively, C-arm fluoroscopy images were obtained with the last rasp size before stem implantation. The alignment and stem fitting of the femoral canal were evaluated. While evaluating the limb leg discrepancy anterior - posterior fluoroscopy image must include both hips and both lesser trochanters. Once this was achieved, the interteardrop line was used and vertical distance between interteardrop line and lesser trochanters measured for limb length discrepancy. Horizontal distance between tip of trochanter major and center of rotation was evaluated as lateral offset. For stem alignment, the femoral stem axis being parallel with the axis of the femoral canal was assessed. Also centralization of femoral stem tip in the femoral canal was assessed. Determination of stem was assessed according to full contact of broach teeth in sub trochanteric region. The stem was size changed unless all criteria above was achieved on fluoroscopy. After the operation, all patients were evaluated with X ray and CT(computerized tomography).

Medial canal flare index (MCFI) can be used for metaphyseal lacking femoral stems. The alignment of the femoral stem with the femoral canal, the limb length discrepancy ( LLD) and the lateral offsets were evaluated on X ray. The stem/endosteal areas at 2 cm above the trochanter minor (T+2) and 2 cm below the trochanter minor (T-2) and the deviation of the stem tip from the center of the femoral canal were evaluated on CT(Computerized tomography) images.

Being tested
fluoroscopy, hip prosthesis
Medical subject headings
Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluoroscopyDevice

    in active group femural stem of hip prosthesis will implanted under fluoroscopy guidance during operation till maximum rasp size reached that fills the medullary canal. ordinary 3-5 sequences per operation

  • hip prosthesisProcedure or surgery

    all patients in the study will undergo hip prosthesis

Study groups in NCT02706002
Study groupRoleWhat they receive
hip prosthesis under fluoroscopyActive comparatorimplantation of femoral stem of hip prosthesis in this group of patients are under fluoroscopic guidance for stem size and stem alignment and last rap before original stem implantation will be checked for alignment , lateral and vertical offsets parameters.
Receives: Device: fluoroscopy; Procedure: hip prosthesis
hip prosthesis without fluoroscopySham comparatorin this group of patients rasping of femoral canal during hip prosthesis is made via anatomic landmarks which confirmed by to senior surgeons and than original stem implanted.
Receives: Procedure: hip prosthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. medial canal flare index ratios on computerized tomography images

    The stem/endosteal areas at 2 cm above the trochanter minor (T+2) and 2 cm below the trochanter minor (T-2) and the deviation of the stem tip from the center of the femoral canal were evaluated on CT images

    Measured: 2 days after operation

Secondary outcomes (4)
  1. centralization of stem tip on computerized tomography images

    distance of stem tip from the center of medullary canal in millimeters

    Measured: 2 days after operation

  2. limb length discrepancy on X ray

    distance between interteardrop line to trochanter minor on anteroposterior x rays

    Measured: 1 day after operation

  3. lateral offset on Xray

    distance between trochanter major tip and hip's center of rotation

    Measured: 1 day after operation

  4. alignment of stem on computerized tomography

    the angle between axis of femoral canal and axis of stem

    Measured: 2 days after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2016 (estimated)
  2. Study startNov 2015
  3. Primary completionJan 2016
  4. Study completionFeb 2016

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02706002
Sponsor's protocol ID
OkmeydaniTRH
Acronym
Fluoroscopy
Status last verified
Mar 2016
First submitted
25 Feb 2016
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing fluoroscopy and hip prosthesis in people with Osteoarthritis, Hip, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization.

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 1 inclusion and 1 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

medial canal flare index ratios on computerized tomography images (time frame: 2 days after operation). 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 11 Mar 2016; AzTrials last refreshed its copy on 29 Oct 2026.

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