Hip ArthritisPTHVarusNCT05443243
Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
An observational study of Hip Arthritis, run by University Hospital, Brest at 1 site in France.
Trial summary
The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Arthritis
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2022to 16 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who received a first-line PTH between 2007 and 2012,
Who may be able to join
- PTH rod implanted in varus,
- Having X-rays and clinical data in their file
- Within a period of less than 6 months
- No opposition
Who cannot join
- PTH in a context of fracture of the femoral neck
- PTH 2nd intention
- Lost to sight
- Patients who died within 6 months
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position
Read the detailed description
ABSTRACT:
Introduction: Femoral stem positioning in the frontal plane has always been considered a fundamental criterion for implant survival and for functional and radiographic outcomes in total hip arthroplasty (THA). The impact of implanting cementless femoral stems in varus alignment on long-term mechanical complications remains poorly defined in the literature. The aim of our study is to compare long-term survivorship as well as functional and radiographic outcomes of stems in varus alignment to stems in neutral alignment.
Patients and Methods: This single center, multi-surgeon, retrospective case-control study will compare a group of 105 THA patients with varus stem alignment (VS) to a control group of 105 THA patients with neutral stem alignment (NS), operated in Brest center between January 2007 and December 2012. The primary outcome measure is implant survival. Secondary outcomes include functional outcomes: HHS, PMA, thigh pain, dislocation and hip ROM; and radiographic outcomes: radiolucency, Agora Roentgenography Assessment (ARA) score, osseointegration, heterotopic ossification, subsidence and stress shielding.
- Conditions
- Hip Arthritis
- Being tested
- Total Hip Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Patient were operated, a Total hip arthroplasty was performed
| Study group | Role | What they receive |
|---|---|---|
| Varus Stems | Patients with a THA Stem implanted in Varus position Receives: Procedure: Total Hip Arthroplasty | |
| Neutral stems | Patients with a THA Stem implanted in Neutral position Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The main outcome measured was the survival of the implant
Measured: It was measured in October 2021
Secondary outcomes (11)
HHS
Functional outcome : - The Harris Hip Score (HHS) [26] which assesses pain, function, deformity and range of motion (ROM) with a maximum score of 100
Measured: It was measured in October 2021
PMA score :
Functional outcome : which assesses pain, gait and mobility with a maximum score of 18
Measured: It was measured in October 2021
Thigh pain
Functional outcome : we measured the rate of patients experiencing pain at the level of the thigh
Measured: It was measured in October 2021
Dislocation
Functional outcome : hip disclocation rate over the follow up period
Measured: It was measured in October 2021
Hip ROM
Functional outcome : Hip range of motion in flexion, adduction, extension, abduction and rotations
Measured: It was measured in October 2021
Radiolucency
Radiographic outcome : - Radiolucency according to the Gruen/Callaghan zones
Measured: It was measured in October 2021
Agora Roentgenography Assessment (ARA) score
Radiographic outcome : - Agora Roentgenography Assessment (ARA) score for cementless femoral stem stability according to Epinette
Measured: It was measured in October 2021
Osseointegration
Radiographic outcome mesured was described in "Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components" Engh CA, Massin P, Suthers KE"
Measured: It was measured in October 2021
Heterotopic ossification
Radiographic outcome : - Brooker classification of heterotopic ossification
Measured: t was measured in October 2021
Subsidence
Radiographic outcome : - Subsidence: considered significant if more than 5 mm between the immediate postoperative x-ray and the last follow-up x-ray. Subsidence was assessed by measuring the distance between the tip of the trochanter and the "shoulder" of the stem
Measured: t was measured in October 2021
Stress shielding.
Radiographic outcome : we measured the rate of patients with Xray showing stress shielding signs
Measured: t was measured in October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start13 May 2022
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hip ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hoel Letissier, MD, Principal investigator, CHU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443243
- Sponsor's protocol ID
- PTHVarus ( 29BRC22.0081)
- Acronym
- PTHVarus
- Status last verified
- Apr 2022
- First submitted
- 17 May 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Batailler C, Fary C, Servien E, Lustig S. Influence of femoral broach shape on stem alignment using anterior approach for total hip arthroplasty: A radiologic comparative study of 3 different stems. PLoS One. 2018 Oct 5;13(10):e0204591. doi: 10.1371/journal.pone.0204591. eCollection 2018.
PubMed 30289882Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, Asmall yi, Ukrainiant Si Selmi T. Varus will have varus; a radiological study to assess and predict varus stem placement in uncemented femoral stems. Hip Int. 2016 Nov 10;26(6):554-560. doi: 10.5301/hipint.5000412. Epub 2016 Oct 15.
PubMed 27768218Fottner A, Woiczinski M, Kistler M, Schroder C, Schmidutz TF, Jansson V, Schmidutz F. Varus malalignment of cementless hip stems provides sufficient primary stability but highly increases distal strain distribution. Clin Biomech (Bristol). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.
PubMed 30005422
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a THA Stem in Varus a Risk Factor of Long-term Mechanical Complication
- ClinicalTrials.gov ID
- NCT05443243
- Acronym / sponsor ID
- PTHVarus / PTHVarus ( 29BRC22.0081)
- Conditions
- Hip Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 13 May 2022 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 5 Jul 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.
The objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted Total Hip Arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position
Detailed description
ABSTRACT:
Introduction: Femoral stem positioning in the frontal plane has always been considered a fundamental criterion for implant survival and for functional and radiographic outcomes in total hip arthroplasty (THA). The impact of implanting cementless femoral stems in varus alignment on long-term mechanical complications remains poorly defined in the literature. The aim of our study is to compare long-term survivorship as well as functional and radiographic outcomes of stems in varus alignment to stems in neutral alignment.
Patients and Methods: This single center, multi-surgeon, retrospective case-control study will compare a group of 105 THA patients with varus stem alignment (VS) to a control group of 105 THA patients with neutral stem alignment (NS), operated in Brest center between January 2007 and December 2012. The primary outcome measure is implant survival. Secondary outcomes include functional outcomes: HHS, PMA, thigh pain, dislocation and hip ROM; and radiographic outcomes: radiolucency, Agora Roentgenography Assessment (ARA) score, osseointegration, heterotopic ossification, subsidence and stress shielding.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varus Stems | – | Procedure: Total Hip ArthroplastyPatients with a THA Stem implanted in Varus position |
| Neutral stems | – | Procedure: Total Hip ArthroplastyPatients with a THA Stem implanted in Neutral position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who received a first-line PTH between 2007 and 2012,
Key inclusion criteria (4 listed)
- PTH rod implanted in varus,
- Having X-rays and clinical data in their file
- Within a period of less than 6 months
- No opposition
Key exclusion criteria (5 listed)
- PTH in a context of fracture of the femoral neck
- PTH 2nd intention
- Lost to sight
- Patients who died within 6 months
- Refusal to participate
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 |
|---|---|---|
| Total Hip ArthroplastyPatient were operated, a Total hip arthroplasty was performed | Procedure or surgery | Neutral stems, Varus Stems |
Primary outcome
Survival rate
Time frame: It was measured in October 2021
The main outcome measured was the survival of the implant
11 secondary outcomes
HHS
Time frame: It was measured in October 2021
PMA score :
Time frame: It was measured in October 2021
Thigh pain
Time frame: It was measured in October 2021
Dislocation
Time frame: It was measured in October 2021
Hip ROM
Time frame: It was measured in October 2021
Radiolucency
Time frame: It was measured in October 2021
Agora Roentgenography Assessment (ARA) score
Time frame: It was measured in October 2021
Osseointegration
Time frame: It was measured in October 2021
Heterotopic ossification
Time frame: t was measured in October 2021
Subsidence
Time frame: t was measured in October 2021
Stress shielding.
Time frame: t was measured in October 2021
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 5 Jul 2022.
- Results publication: PubMed 30289882Batailler C, Fary C, Servien E, Lustig S. Influence of femoral broach shape on stem alignment using anterior approach for total hip arthroplasty: A radiologic comparative study of 3 different stems. PLoS One. 2018 Oct 5;13(10):e0204591. doi: 10.1371/journal.pone.0204591. eCollection 2018.
- Results publication: PubMed 27768218Murphy CG, Bonnin MP, Desbiolles AH, Carrillon Y, Asmall yi, Ukrainiant Si Selmi T. Varus will have varus; a radiological study to assess and predict varus stem placement in uncemented femoral stems. Hip Int. 2016 Nov 10;26(6):554-560. doi: 10.5301/hipint.5000412. Epub 2016 Oct 15.
- Results publication: PubMed 30005422Fottner A, Woiczinski M, Kistler M, Schroder C, Schmidutz TF, Jansson V, Schmidutz F. Varus malalignment of cementless hip stems provides sufficient primary stability but highly increases distal strain distribution. Clin Biomech (Bristol). 2018 Oct;58:14-20. doi: 10.1016/j.clinbiomech.2018.07.006. Epub 2018 Jul 5.
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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.
Hoel Letissier, MD principal investigator
CHU de Brest
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 Hip Arthritis, run by University Hospital, Brest at 1 site in France.
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 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 5 Jul 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 France. 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?
Survival rate (time frame: It was measured in October 2021). 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 NCT05443243, which also lists 3 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 5 Jul 2022.