OsteoarthritisVARABGNCT04653090
Varus Stem Positioning of a Cementless Anatomical THA. (VARABG)
An observational study of Osteoarthritis and Arthroplasty Complications, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Arthroplasty Complications
- What is being tested?
- Xray
- How many people
- 283 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2018to 5 Nov 2020
- 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: The investigators identified all patients who underwent proximal HA-coated anatomic tapered femoral stem primary THAs between October 1998 and July 2008, through our institutional total joint registry. The data were prospectively collected on the Orthowave© database. This included patients who had an uncemented ABG-2 stem (Stryker, Mahwah, NJ). The study was a test-case retrospective analysis and an institutional review board approval was obtained prior to initiation of the study.
Who may be able to join
- All patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol.
Who cannot join
- Etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis),
- Complex cases with additional procedure,
- Dual-taper modular or cemented stem,
- Incomplete preoperative data or less than one-year postoperative data.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Varus Stem Positioning Does Not Affect Long-term Functional Outcome in Cementless Anatomical Total Hip Arthroplasty.
Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.
Read the detailed description
Data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in THA between 1998 and 2008. After exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). Survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. Mean follow-up was 10 years.
- Conditions
- Osteoarthritis, Arthroplasty Complications
- Being tested
- Xray
- Keywords
- Total hip arthroplasty, varus alignment, anatomical stem, survivorship
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XrayDiagnostic test
Hip AP Xray
| Study group | Role | What they receive |
|---|---|---|
| Varus group | Radiographic stem axis was assessed on standard anteroposterior hip radiographs performed at the 3-month follow-up visit. Alignment was evaluated as described by Reina et al., by the angular deviation of the anatomic femoral axis and the stem axis. The 3 degrees minimal-value was considered to be the threshold defining a varus stem. Receives: Diagnostic Test: Xray | |
| Neutral group | Alignment between anatomic femoral axis ans stem axis was less than 3°. Receives: Diagnostic Test: Xray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.
Kaplan-Meier survivorships free of revision of the femoral component for any reason, femoral fracture and revision of femoral component for fracture were calculated and compared by log-rank test for both group.
Measured: Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.
Secondary outcomes (2)
Long-term clinical outcomes with varus or neutral femoral stem.
Clinical status was assessed by the Harris hip score (HHS).
Measured: Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.
Long-term radiological outcomes with varus or neutral femoral stem.
Radiological assessment was conducted at the last follow-up in charge antero-posterior and profile X-Ray.
Measured: Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start1 Jan 2018
- Primary completion1 May 2018
- Study completion5 Nov 2020
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 OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04653090
- Sponsor's protocol ID
- 20.0035
- Acronym
- VARABG
- Status last verified
- Nov 2020
- First submitted
- 13 Nov 2020
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Reina N, Salib CG, Perry KI, Hanssen AD, Berry DJ, Abdel MP. Mild Coronal Stem Malalignment Does Not Negatively Impact Survivorship or Clinical Results in Uncemented Primary Total Hip Arthroplasties With Dual-Tapered Implants. J Arthroplasty. 2019 Jun;34(6):1127-1131. doi: 10.1016/j.arth.2019.01.055. Epub 2019 Jan 31.
PubMed 30773361Khalily C, Lester DK. Results of a tapered cementless femoral stem implanted in varus. J Arthroplasty. 2002 Jun;17(4):463-6. doi: 10.1054/arth.2002.32171.
PubMed 12066277Min BW, Song KS, Bae KC, Cho CH, Kang CH, Kim SY. The effect of stem alignment on results of total hip arthroplasty with a cementless tapered-wedge femoral component. J Arthroplasty. 2008 Apr;23(3):418-23. doi: 10.1016/j.arth.2007.04.002. Epub 2007 Nov 9.
PubMed 18358382
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Varus Stem Positioning Does Not Affect Long-term Functional Outcome in Cementless Anatomical Total Hip Arthroplasty.
- ClinicalTrials.gov ID
- NCT04653090
- Acronym / sponsor ID
- VARABG / 20.0035
- Conditions
- Osteoarthritis, Arthroplasty Complications
- Keywords
- Total hip arthroplasty, varus alignment, anatomical stem, survivorship
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 4 Dec 2020 (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.
Varus positioning is the most common femoral malposition in total hip arthroplasty (THA). The aim of this study was to compare the long-term results of an anatomical cementless femoral stem positioned in varus with those in neutral alignment.
Detailed description
Data were prospectively collected and retrospectively reviewed for all patients who received a cementless anatomical femoral stem in THA between 1998 and 2008. After exclusion criteria applied, 127 stems had an varus axis deviated by more than 3 degrees (varus group) and 156 had an alignment between 0 and 2.9° from the femoral axis (neutral group). Survivorship rates, complications, clinical scores, thigh pain, radiological score, cortical hypertrophy and filling rate were analyzed. Mean follow-up was 10 years.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varus group | – | Diagnostic Test: XrayRadiographic stem axis was assessed on standard anteroposterior hip radiographs performed at the 3-month follow-up visit. Alignment was evaluated as described by Reina et al., by the angular deviation of the anatomic femoral axis and the stem axis. The 3 degrees minimal-value was considered to be the threshold defining a varus stem. |
| Neutral group | – | Diagnostic Test: XrayAlignment between anatomic femoral axis ans stem axis was less than 3°. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators identified all patients who underwent proximal HA-coated anatomic tapered femoral stem primary THAs between October 1998 and July 2008, through our institutional total joint registry. The data were prospectively collected on the Orthowave© database. This included patients who had an uncemented ABG-2 stem (Stryker, Mahwah, NJ). The study was a test-case retrospective analysis and an institutional review board approval was obtained prior to initiation of the study.
Key inclusion criteria (1 listed)
- All patients received by several senior surgeons, the same standardized posterolateral total hip arthroplasty, and the same rehabilitation protocol.
Key exclusion criteria (4 listed)
- Etiologies other than osteoarthritis (osteonecrosis, fracture, dysplasia, rheumatoïd arthritis),
- Complex cases with additional procedure,
- Dual-taper modular or cemented stem,
- Incomplete preoperative data or less than one-year postoperative data.
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 |
|---|---|---|
| XrayHip AP Xray | Diagnostic test | Neutral group, Varus group |
Primary outcome
Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem.
Time frame: Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.
Kaplan-Meier survivorships free of revision of the femoral component for any reason, femoral fracture and revision of femoral component for fracture were calculated and compared by log-rank test for both group.
2 secondary outcomes
Long-term clinical outcomes with varus or neutral femoral stem.
Time frame: Clinical evaluation was carried out through study completion at an average of 10 years by the surgeon.
Long-term radiological outcomes with varus or neutral femoral stem.
Time frame: Radiological evaluation was carried out through study completion at an average of 10 years by the surgeon.
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 4 Dec 2020.
- Background: PubMed 30773361Reina N, Salib CG, Perry KI, Hanssen AD, Berry DJ, Abdel MP. Mild Coronal Stem Malalignment Does Not Negatively Impact Survivorship or Clinical Results in Uncemented Primary Total Hip Arthroplasties With Dual-Tapered Implants. J Arthroplasty. 2019 Jun;34(6):1127-1131. doi: 10.1016/j.arth.2019.01.055. Epub 2019 Jan 31.
- Background: PubMed 12066277Khalily C, Lester DK. Results of a tapered cementless femoral stem implanted in varus. J Arthroplasty. 2002 Jun;17(4):463-6. doi: 10.1054/arth.2002.32171.
- Background: PubMed 18358382Min BW, Song KS, Bae KC, Cho CH, Kang CH, Kim SY. The effect of stem alignment on results of total hip arthroplasty with a cementless tapered-wedge femoral component. J Arthroplasty. 2008 Apr;23(3):418-23. doi: 10.1016/j.arth.2007.04.002. Epub 2007 Nov 9.
- Individual participant dataSharing planned: No
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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?
An observational study of Osteoarthritis and Arthroplasty Complications, run by Centre Hospitalier Universitaire de Nīmes 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 1 inclusion and 4 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 4 Dec 2020. 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?
Long-term survival of THA with varus or neutral cementless fixation of a proximal HA-coated anatomic tapered femoral stem. (time frame: Survival evaluation was carried out through study completion at an average of 10 years by the surgeon.). 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 NCT04653090, 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 4 Dec 2020.