Osteoarthritis, HipNCT03147131
Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem
A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by University Hospital Ulm.
Trial summary
The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Total Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2010to Jul 2017
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary or secondary osteoarthritis of the hip
- written informed consent
- indication for cementless total hip arthroplasty
Who cannot join
- previous surgery in the same hip
- femoral fracture
- metabolic bone disease
- drugs affecting bone quality
- contralateral THA within the study period
- infectious disease or bony tumor
About this study
Official title: Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem: Five-Year Results Of A Prospective, Randomized DEXA-Analysis
The aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.
Read the detailed description
After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).
- Conditions
- Osteoarthritis, Hip
- Being tested
- Total Hip Arthroplasty
- Keywords
- Total Hip Arthroplasty, Short Stem, DEXA
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Hip ArthroplastyProcedure or surgery
Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.
| Study group | Role | What they receive |
|---|---|---|
| Fitmore short stem | Active comparator | Intervention: Total hip arthroplasty with an uncemented femoral short stem, the Fitmore short stem (Zimmer, Warsaw, USA). Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA).
Device: Fitmore Short Stem Receives: Procedure: Total Hip Arthroplasty |
| CLS straight stem | Active comparator | Intervention: Total hip arthroplasty with an uncemented femoral straight stem, the CLS short stem (Zimmer, Warsaw, USA).Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA).
Device: CLS Straight Stem Receives: Procedure: Total Hip Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stem specific stress shielding of a short compared to a straight hip stem
Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem
Measured: Five years postoperatively
Secondary outcomes (1)
Clinical Outcome after short compared to straight stem THA
Clinical outcome measured with the Harris Hip Score and the WOMAC
Measured: Five years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start1 Aug 2010
- Primary completionFeb 2012
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, HipStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Ulm
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. med Ralf Bieger, University Hospital Ulm
- Investigators
- Ralf Bieger, PD Dr., Principal investigator, University Hospital Ulm - Department of Orthopedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147131
- Sponsor's protocol ID
- D.3067-244/10
- Status last verified
- May 2017
- First submitted
- 19 Dec 2016
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Freitag T, Hein MA, Wernerus D, Reichel H, Bieger R. Bone remodelling after femoral short stem implantation in total hip arthroplasty: 1-year results from a randomized DEXA study. Arch Orthop Trauma Surg. 2016 Jan;136(1):125-30. doi: 10.1007/s00402-015-2370-z. Epub 2015 Nov 27.
PubMed 26613788Meyer JS, Freitag T, Reichel H, Bieger R. Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem. Orthop Traumatol Surg Res. 2020 Dec;106(8):1495-1500. doi: 10.1016/j.otsr.2020.04.023. Epub 2020 Oct 31.
PubMed 33132094
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periprosthetic Bone Mineral Density Changes After Implantation Of A Short Hip Stem Compared To A Straight Stem: Five-Year Results Of A Prospective, Randomized DEXA-Analysis
- ClinicalTrials.gov ID
- NCT03147131
- Acronym / sponsor ID
- D.3067-244/10
- Conditions
- Osteoarthritis, Hip
- Keywords
- Total Hip Arthroplasty, Short Stem, DEXA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University Hospital UlmUniversity, hospital or other
- Study start
- 1 Aug 2010 (actual)
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jul 2017 (estimated)
- First posted
- 10 May 2017 (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 aim of this study is to evaluate periprosthetic bone mineral density (BMD) changes in the proximal femur after implantation of the Fitmore compared to the CLS stem.
Detailed description
After power analysis, 140 consecutive patients were prospectively included in the randomisation protocol receiving either a Fitmore short or a CLS straight stem. The short stem was assigned in 57 (37% females) cases and the straight stem in 83 (38% females) hips. Periprosthetic bone mineral density was measured before surgery, 7 days, 3, 12 and 60 months postoperatively, using dual energy x-ray absorptiometry (DEXA). The results of the first postoperative measurement served as the baseline value. Because of the different length of the two prostheses we used adapted Gruen zones to divide the periprosthetic bone in seven regions of interest (ROI) with equal length in the proximal zones 1,2,6 and 7, only the regions 3 and 5 featured different sizes. Clinical results were recorded using the WOMAC and the Harris hip score (HHS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fitmore short stem | Active comparator | Procedure: Total Hip ArthroplastyIntervention: Total hip arthroplasty with an uncemented femoral short stem, the Fitmore short stem (Zimmer, Warsaw, USA). Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: Fitmore Short Stem |
| CLS straight stem | Active comparator | Procedure: Total Hip ArthroplastyIntervention: Total hip arthroplasty with an uncemented femoral straight stem, the CLS short stem (Zimmer, Warsaw, USA).Furthermore, an uncemented cup (Allofit, Zimmer, Warzaw, USA). Device: CLS Straight Stem |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary or secondary osteoarthritis of the hip
- written informed consent
- indication for cementless total hip arthroplasty
Key exclusion criteria (6 listed)
- previous surgery in the same hip
- femoral fracture
- metabolic bone disease
- drugs affecting bone quality
- contralateral THA within the study period
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 ArthroplastyTotal hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem. | Procedure or surgery | CLS straight stem, Fitmore short stem |
Primary outcome
Stem specific stress shielding of a short compared to a straight hip stem
Time frame: Five years postoperatively
Periprosthetic Bone Mineral Density changes around a total hip arthroplasty stem
1 secondary outcome
Clinical Outcome after short compared to straight stem THA
Time frame: Five years postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 26613788Freitag T, Hein MA, Wernerus D, Reichel H, Bieger R. Bone remodelling after femoral short stem implantation in total hip arthroplasty: 1-year results from a randomized DEXA study. Arch Orthop Trauma Surg. 2016 Jan;136(1):125-30. doi: 10.1007/s00402-015-2370-z. Epub 2015 Nov 27.
- Derived from this study: PubMed 33132094Meyer JS, Freitag T, Reichel H, Bieger R. Mid-term gender-specific differences in periprosthetic bone remodelling after implantation of a curved bone-preserving hip stem. Orthop Traumatol Surg Res. 2020 Dec;106(8):1495-1500. doi: 10.1016/j.otsr.2020.04.023. Epub 2020 Oct 31.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
Related trials for Osteoarthritis, Hip
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Recruiting
Effects of EDUcation and EXercise Compared to Education Alone on Clinical and Physiological Outcomes in Patients With Hip Osteoarthritis
Hip Osteoarthritis
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
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.
Ralf Bieger, PD Dr. principal investigator
University Hospital Ulm - Department of Orthopedic Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Total Hip Arthroplasty in people with Osteoarthritis, Hip, run by University Hospital Ulm.
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 3 inclusion and 6 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 16 May 2017. 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?
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?
Stem specific stress shielding of a short compared to a straight hip stem (time frame: Five years postoperatively). 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 NCT03147131, which also lists 2 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 16 May 2017.