Hip ArthropathyNCT05670717
Subsidence of Cementless Stem Following Arthroplasty for Fracture Neck of Femur
An observational study of Hip Arthropathy, run by Assiut University.
Trial summary
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur. Read more about this study
- Who is it for?
- Ages Up to 80 years
- Conditions the study is for
- Hip Arthropathy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2023to 1 Jul 2024
- 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 Up to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cases that previously underwent cementless hip arthroplasty for fracture neck of femur at arthroplasty unit at assiut university hospital.
Who may be able to join
- cases that underwent cementless hip arthroplasty for fracture neck of femur
Who cannot join
- 1- malignancy. 2- Previous plating. 3- Revision for infection. 4- dysplasia. 5- SLE and Rheumatoid Arthritis
Trial locations and contacts
No sites are listed yet.
About this study
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.
Read the detailed description
Neck of femur fractures are occurring at an increased incidence, Functionally independent patients without cognitive impairment can expect reasonable life expectancy, this indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. THA should be considered the gold standard producing better functional and quality of life outcomes lower reoperation rates and better cost effectiveness.
THA is associated with better functional outcomes and a lower risk of revision surgery in self-sufficient, physically active patients , Instability is the leading complication of conventional THA and occurs with a higher incidence ,THA remains the option of choice as it provides better functional outcomes.
Although the clinical outcomes of total hip arthroplasty (THA) in elderly patients with femoral neck fracture were reported to be better than hemiarthroplasty, hemiarthroplasty was frequently recommended in cases where the patient has a low functional level and/or osteoporosis and high rates of postoperative dislocation of total hip arthroplasty.
Hip joint replacement surgery is considered one of the most successful operations due to its high success and low complication rate , one possible risk factor for early failure of total hip arthroplasty (THA) is the subsidence of the femoral stem , Cementless THA in particular could be susceptible to subsidence.
Cementless femoral stems ideally achieve direct integration between the stem surface and endosteal bone with the aim of decreasing the incidence of aseptic loosening.
Subsidence is defined as a distalization of the femoral stem in reference to the greater trochanter.
Measurement of subsidence of uncemented femoral stems can be used to evaluate the likelihood of long term stem component loosening and therefore clinical failure .
- Conditions
- Hip Arthropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.
Radiological evaluation of stem subsidence by standing anteroposterior radiograph on hip joint 1 year post-operatively to be compared with the previous anteroposterior hip radiograph that was done immediately after operation and assessment of subsidence by measuring the distance between the apex of major trochanter and the stem shoulder or measuring the distance between stem shoulder of hip prosthesis and the most prominent point of lesser trochanter
Measured: an average of 1 year post operatively
Secondary outcomes (1)
1- Harris Hip Scoring for assessment pain and distance walked and range of motion and quality of life. 2- Health Survey (SF-36) Scoring.foe assesment of health ststus and daily activities 3- Any complications detected.
Measured: 1 year after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completion1 May 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amgad Rasmy Moreed Gerges, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670717
- Sponsor's protocol ID
- Subsidence of Cementless Stem
- Status last verified
- Jan 2023
- First submitted
- 19 May 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guyen O. Hemiarthroplasty or total hip arthroplasty in recent femoral neck fractures? Orthop Traumatol Surg Res. 2019 Feb;105(1S):S95-S101. doi: 10.1016/j.otsr.2018.04.034. Epub 2018 Nov 16.
PubMed 30449680Burgers PT, Van Geene AR, Van den Bekerom MP, Van Lieshout EM, Blom B, Aleem IS, Bhandari M, Poolman RW. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012 Aug;36(8):1549-60. doi: 10.1007/s00264-012-1569-7. Epub 2012 May 24.
PubMed 22623062Leiss F, Gotz JS, Meyer M, Maderbacher G, Reinhard J, Parik L, Grifka J, Greimel F. Differences in femoral component subsidence rate after THA using an uncemented collarless femoral stem: full weight-bearing with an enhanced recovery rehabilitation versus partial weight-bearing. Arch Orthop Trauma Surg. 2022 Apr;142(4):673-680. doi: 10.1007/s00402-021-03913-0. Epub 2021 May 21.
PubMed 34019145Mazoochian F, Schrimpf FM, Kircher J, Mayer W, Hauptmann S, Fottner A, Muller PE, Pellengahr C, Jansson V. Proximal loading of the femur leads to low subsidence rates: first clinical results of the CR-stem. Arch Orthop Trauma Surg. 2007 Aug;127(6):397-401. doi: 10.1007/s00402-007-0384-x. Epub 2007 Jun 30.
PubMed 17602233Parvizi J, Keisu KS, Hozack WJ, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: a long-term study of the Taperloc stem. J Arthroplasty. 2004 Feb;19(2):151-6. doi: 10.1016/j.arth.2003.10.003.
PubMed 14973856Ries C, Boese CK, Dietrich F, Miehlke W, Heisel C. Femoral stem subsidence in cementless total hip arthroplasty: a retrospective single-centre study. Int Orthop. 2019 Feb;43(2):307-314. doi: 10.1007/s00264-018-4020-x. Epub 2018 Jun 18.
PubMed 29916001Al-Najjim M, Khattak U, Sim J, Chambers I. Differences in subsidence rate between alternative designs of a commonly used uncemented femoral stem. J Orthop. 2016 Jul 5;13(4):322-6. doi: 10.1016/j.jor.2016.06.026. eCollection 2016 Dec.
PubMed 27436922Hoskins W, Webb D, Bingham R, Pirpiris M, Griffin XL. Evidence based management of intracapsular neck of femur fractures. Hip Int. 2017 Sep 19;27(5):415-424. doi: 10.5301/hipint.5000519. Epub 2017 Sep 11.
PubMed 28956892
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subsidence of Cementless Stem Following Arthroplasty for Fracture Neck of Femur
- ClinicalTrials.gov ID
- NCT05670717
- Acronym / sponsor ID
- Subsidence of Cementless Stem
- Conditions
- Hip Arthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 4 Jan 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.
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.
Detailed description
Neck of femur fractures are occurring at an increased incidence, Functionally independent patients without cognitive impairment can expect reasonable life expectancy, this indicates the need for a durable surgical option that optimises the chance to return to pre-injury functional status, with minimal risk of complications and reoperation. THA should be considered the gold standard producing better functional and quality of life outcomes lower reoperation rates and better cost effectiveness.
THA is associated with better functional outcomes and a lower risk of revision surgery in self-sufficient, physically active patients , Instability is the leading complication of conventional THA and occurs with a higher incidence ,THA remains the option of choice as it provides better functional outcomes.
Although the clinical outcomes of total hip arthroplasty (THA) in elderly patients with femoral neck fracture were reported to be better than hemiarthroplasty, hemiarthroplasty was frequently recommended in cases where the patient has a low functional level and/or osteoporosis and high rates of postoperative dislocation of total hip arthroplasty.
Hip joint replacement surgery is considered one of the most successful operations due to its high success and low complication rate , one possible risk factor for early failure of total hip arthroplasty (THA) is the subsidence of the femoral stem , Cementless THA in particular could be susceptible to subsidence.
Cementless femoral stems ideally achieve direct integration between the stem surface and endosteal bone with the aim of decreasing the incidence of aseptic loosening.
Subsidence is defined as a distalization of the femoral stem in reference to the greater trochanter.
Measurement of subsidence of uncemented femoral stems can be used to evaluate the likelihood of long term stem component loosening and therefore clinical failure .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cases that previously underwent cementless hip arthroplasty for fracture neck of femur at arthroplasty unit at assiut university hospital.
Key inclusion criteria (1 listed)
- cases that underwent cementless hip arthroplasty for fracture neck of femur
Key exclusion criteria (1 listed)
- 1- malignancy. 2- Previous plating. 3- Revision for infection. 4- dysplasia. 5- SLE and Rheumatoid Arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur.
Time frame: an average of 1 year post operatively
Radiological evaluation of stem subsidence by standing anteroposterior radiograph on hip joint 1 year post-operatively to be compared with the previous anteroposterior hip radiograph that was done immediately after operation and assessment of subsidence by measuring the distance between the apex of major trochanter and the stem shoulder or measuring the distance between stem shoulder of hip prosthesis and the most prominent point of lesser trochanter
1 secondary outcome
1- Harris Hip Scoring for assessment pain and distance walked and range of motion and quality of life. 2- Health Survey (SF-36) Scoring.foe assesment of health ststus and daily activities 3- Any complications detected.
Time frame: 1 year after surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Background: PubMed 30449680Guyen O. Hemiarthroplasty or total hip arthroplasty in recent femoral neck fractures? Orthop Traumatol Surg Res. 2019 Feb;105(1S):S95-S101. doi: 10.1016/j.otsr.2018.04.034. Epub 2018 Nov 16.
- Background: PubMed 22623062Burgers PT, Van Geene AR, Van den Bekerom MP, Van Lieshout EM, Blom B, Aleem IS, Bhandari M, Poolman RW. Total hip arthroplasty versus hemiarthroplasty for displaced femoral neck fractures in the healthy elderly: a meta-analysis and systematic review of randomized trials. Int Orthop. 2012 Aug;36(8):1549-60. doi: 10.1007/s00264-012-1569-7. Epub 2012 May 24.
- Background: PubMed 34019145Leiss F, Gotz JS, Meyer M, Maderbacher G, Reinhard J, Parik L, Grifka J, Greimel F. Differences in femoral component subsidence rate after THA using an uncemented collarless femoral stem: full weight-bearing with an enhanced recovery rehabilitation versus partial weight-bearing. Arch Orthop Trauma Surg. 2022 Apr;142(4):673-680. doi: 10.1007/s00402-021-03913-0. Epub 2021 May 21.
- Background: PubMed 17602233Mazoochian F, Schrimpf FM, Kircher J, Mayer W, Hauptmann S, Fottner A, Muller PE, Pellengahr C, Jansson V. Proximal loading of the femur leads to low subsidence rates: first clinical results of the CR-stem. Arch Orthop Trauma Surg. 2007 Aug;127(6):397-401. doi: 10.1007/s00402-007-0384-x. Epub 2007 Jun 30.
- Background: PubMed 14973856Parvizi J, Keisu KS, Hozack WJ, Sharkey PF, Rothman RH. Primary total hip arthroplasty with an uncemented femoral component: a long-term study of the Taperloc stem. J Arthroplasty. 2004 Feb;19(2):151-6. doi: 10.1016/j.arth.2003.10.003.
- Background: PubMed 29916001Ries C, Boese CK, Dietrich F, Miehlke W, Heisel C. Femoral stem subsidence in cementless total hip arthroplasty: a retrospective single-centre study. Int Orthop. 2019 Feb;43(2):307-314. doi: 10.1007/s00264-018-4020-x. Epub 2018 Jun 18.
- Background: PubMed 27436922Al-Najjim M, Khattak U, Sim J, Chambers I. Differences in subsidence rate between alternative designs of a commonly used uncemented femoral stem. J Orthop. 2016 Jul 5;13(4):322-6. doi: 10.1016/j.jor.2016.06.026. eCollection 2016 Dec.
- Background: PubMed 28956892Hoskins W, Webb D, Bingham R, Pirpiris M, Griffin XL. Evidence based management of intracapsular neck of femur fractures. Hip Int. 2017 Sep 19;27(5):415-424. doi: 10.5301/hipint.5000519. Epub 2017 Sep 11.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Arthropathy, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 4 Jan 2023. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amgad Rasmy Moreed Gerges, fellow (01205302836, Amgad.20133877@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of subsidence of cementless stem following arthroplasty for fracture neck of femur. (time frame: an average of 1 year post operatively). 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 NCT05670717, which also lists 8 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 4 Jan 2023.