Osteoarthritis, HipNCT02743208
Evaluation of a Short Femoral Stem in Total Hip Arthroplasty
A study testing Short stem hip arthroplasty (SHA) and Total hip arthroplasty (THA) in people with Osteoarthritis, Hip, run by St. Olavs Hospital.
Trial summary
In recent years, short femoral stems have been introduced. Short stems are designed based on traditional stems with good clinical results. The assumed benefit of short stems is that they are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic bone stock is better. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Osteoarthritis, Hip
- What is being tested?
- Short stem hip arthroplasty (SHA) and Total hip arthroplasty (THA)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2019to Sep 2021
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1)
Who cannot join
- osteoporosis
- pregnancy
- musculoskeletal problems compromising rehabilitation
- corticosteroid treatment
- dementia
- developmental dysplasia (Crowe grade II-IV)
Show all 10Show fewer
- osteosynthesis in place
- revision surgery
- joint infection
- malignancy of the femur/pelvis
About this study
Official title: Evaluation of a Short Femoral Stem in Total Hip Arthroplasty. A Comparative Study on Stability, Bone Remodelling and Patient Outcome.
In recent years, short femoral stems have been introduced. Short stems are designed based on traditional stems with good clinical results. The assumed benefit of short stems is that they are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a good proximal bone stock makes later revision surgery less technically demanding. However, the short stem design could compromise the stability of the prosthesis, and there has been reported diverging results regarding correct positioning of short stems. This may be due to the lack of inherent aiming provided by the tip of the traditional long stems. We want to clinically evaluate the stability and bone remodelling pattern of a new short femoral stem based on a standard stem with excellent long time results. In addition we will compare the two different stems regarding positioning, when using a newly developed guiding broach for the short stem, and the standard broach for the long stem. Finally, patient reported clinical outcome scores will be evaluated with respect to implant and biomechanical reconstruction.
The aim of this study is to evaluate whether this specific short femoral stem is stable, safe to use, and if it provides the expected beneficial effects on bone remodelling.
Read the detailed description
Total hip arthroplasty (THA) is a successful treatment of osteoarthritis and other destructive diseases of the hip joint, relieving pain and restoring the function of the joint. In Norway more than 7000 patients undergo primary hip replacement every year, and the incidence is increasing.
The femoral component of a hip prosthesis is traditionally anchored to the femoral bone with a stem introduced into the femoral canal and fixated with cement, or through bony ingrowth. Over the recent years, short femoral stems have been introduced, among other reasons to meet the increasing popularity of mini-invasive surgical procedures. The short stems are meant to be easier to introduce through a small incision like used in muscle conserving anterior and posterior approaches. Secondly, and biomechanically relevant, an important design related benefit of the short femoral stems is thought to prevent periprosthetic bone resorption. Bone remodels as a response to mechanical loading. When a stiff implant is inserted into the femoral canal, the load will "bypass" the proximal femur through the implant, and is transferred to bone distally. This results in a negative bone remodelling in the proximal femur, which leads to bone resorption, often termed as "stress shielding". Stress shielding is observed around most uncemented implants, and mainly occurs within the first 6 - 24 months postoperatively. The extent of implant coating, the material stiffness, design and the size of the stem are found to influence the degree of stress shielding. The short stems are thus designed based on the theory that proximal load transfer preserves metaphyseal bone.
Loss of proximal bone stock due to stress shielding is a controversial subject, but has several possible consequences. The exact clinical implications are not entirely determined, but periprosthetic fractures and more challenging revision surgery are recognized problems. In a revision setting it is favourable to have good proximal bone stock to achieve primary stability of the implant. Peroperative fracture and compromised stability of the implant may be a potential problem in stress-shielded bone. Furthermore, already stress-shielded bone in the proximal femur may give wear debris easier access to the interface between implant and bone, resulting in further osteolysis. Short-term results for short-stemmed implants are encouraging in some clinical papers, but most of the available implants lack long-time clinical documentation. Most papers on stress shielding are not randomized trials between long and short stems. There are a few reports of increased revision rate and challenging surgical procedures.
Uncemented prosthetic hip implants are dependent on excellent primary stability to achieve osseointegration and long-term stability. It is recognized that excessive micromotion at the bone-implant interface is associated with formation of a soft tissue and loosening of implants. Micromotion above 40μm leads to partial bone ingrowth, while values above 150μm completely inhibit bone ingrowth. The main concern in short femoral stems is that stability might be compromised. This might be due to the relatively less contact surface. There are no long term results on stability of short femoral stems available, but in vitro studies shows no significant reduction in stability of prostheses with comparable stem length to the Furlong Evolution.
Malpositioning may result in a discrepancy between the reconstructed and the native biomechanical anatomy of the hip. Altered biomechanical properties may influence the clinical outcome and survival of implants. It has been shown that horizontal femoral offset, increases significantly more using a short femoral stem compared to conventional femoral stems. Compared to the contralateral hip, horizontal femoral offset was significantly increased only when using short stems. Increased femoral offset increases the torsion forces along the stem, which in turn raises the need for primary stability to avoid micromotion. It is also shown that a short stem has a wider range of varus-valgus in the stem-shaft axis, On the other there were found no significant differences in biomechanical reconstruction of the hip when using a "broach only" short stem, or a "ream and broach" standard stem.
If there are significant differences in the biomechanical hip reconstruction, will this affect patient reported outcome?
- Conditions
- Osteoarthritis, Hip
- Being tested
- Short stem hip arthroplasty (SHA), Total hip arthroplasty (THA)
- Keywords
- Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, 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.
Short stem hip arthroplasty (SHA)Device
Furlong Evolution femoral stem
Total hip arthroplasty (THA)Device
Furlong H-A.C. femoral stem
| Study group | Role | What they receive |
|---|---|---|
| Furlong Evolution femoral stem | Experimental | Short stem hip arthroplasty (SHA) using a Furlong Evolution femoral stem, and a Furlong H-A.C. Cortical Scree Fit (CSF) plus acetabular cup system. Receives: Device: Short stem hip arthroplasty (SHA) |
| Furlong H-A.C. femoral stem | Active comparator | Total hip arthroplasty (THA) using a Furlong H-A.C. femoral stem, and a Furlong H-A.C. CSF plus acetabular cup system. Receives: Device: Total hip arthroplasty (THA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periprosthetic bone mineral density (BMD)
Postoperative change in BMD following bone remodelling measured by dual-energy x-ray absorptiometry (DXA)
Measured: 2 years
Secondary outcomes (5)
Migration of femoral stem
Migration of femoral stem measured by radiostereometric analysis (RSA)
Measured: 2 years
Biomechanical reconstruction of hip anatomy
Biomechanical key measures in hip anatomy after reconstruction of the hip joint, compared to native anatomy in contralateral hip is analysed on a metric scale to compare the following positions: Horizontal centre of rotation. Vertical centre of rotation. Horizontal femoral offset. Vertical femoral offset. Abductor lever arm. Limb length. Stem-shaft angle, or valgus/varus.
Measured: 2 years
Hip disability osteoarthritis outcome score (HOOS)
Measured: 2 years
Harris hip score
Measured: 2 years
Health-related quality of life (EQ-5D).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startSep 2019 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionSep 2021 (estimated)
Why it stopped: problem due to new regulations for CE-marking of implants; lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olav Foss, md phd, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743208
- Sponsor's protocol ID
- 2015/846
- Status last verified
- Dec 2019
- First submitted
- 31 Mar 2016
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Short Femoral Stem in Total Hip Arthroplasty. A Comparative Study on Stability, Bone Remodelling and Patient Outcome.
- ClinicalTrials.gov ID
- NCT02743208
- Acronym / sponsor ID
- 2015/846
- Conditions
- Osteoarthritis, Hip
- Keywords
- Arthroplasty, Replacement, Hip, Surgical Procedures, Operative, Hip Prosthesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: problem due to new regulations for CE-marking of implants; lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2021 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- 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.
In recent years, short femoral stems have been introduced. Short stems are designed based on traditional stems with good clinical results. The assumed benefit of short stems is that they are easier to use in mini-invasive surgery, and that preservation of proximal periprosthetic bone stock is better. Preservation of periprosthetic bone in the proximal femur is thought to secure long time anchoring of the implant, and reduce the risk of loosening. In addition, a good proximal bone stock makes later revision surgery less technically demanding. However, the short stem design could compromise the stability of the prosthesis, and there has been reported diverging results regarding correct positioning of short stems. This may be due to the lack of inherent aiming provided by the tip of the traditional long stems. We want to clinically evaluate the stability and bone remodelling pattern of a new short femoral stem based on a standard stem with excellent long time results. In addition we will compare the two different stems regarding positioning, when using a newly developed guiding broach for the short stem, and the standard broach for the long stem. Finally, patient reported clinical outcome scores will be evaluated with respect to implant and biomechanical reconstruction.
The aim of this study is to evaluate whether this specific short femoral stem is stable, safe to use, and if it provides the expected beneficial effects on bone remodelling.
Detailed description
Total hip arthroplasty (THA) is a successful treatment of osteoarthritis and other destructive diseases of the hip joint, relieving pain and restoring the function of the joint. In Norway more than 7000 patients undergo primary hip replacement every year, and the incidence is increasing.
The femoral component of a hip prosthesis is traditionally anchored to the femoral bone with a stem introduced into the femoral canal and fixated with cement, or through bony ingrowth. Over the recent years, short femoral stems have been introduced, among other reasons to meet the increasing popularity of mini-invasive surgical procedures. The short stems are meant to be easier to introduce through a small incision like used in muscle conserving anterior and posterior approaches. Secondly, and biomechanically relevant, an important design related benefit of the short femoral stems is thought to prevent periprosthetic bone resorption. Bone remodels as a response to mechanical loading. When a stiff implant is inserted into the femoral canal, the load will "bypass" the proximal femur through the implant, and is transferred to bone distally. This results in a negative bone remodelling in the proximal femur, which leads to bone resorption, often termed as "stress shielding". Stress shielding is observed around most uncemented implants, and mainly occurs within the first 6 - 24 months postoperatively. The extent of implant coating, the material stiffness, design and the size of the stem are found to influence the degree of stress shielding. The short stems are thus designed based on the theory that proximal load transfer preserves metaphyseal bone.
Loss of proximal bone stock due to stress shielding is a controversial subject, but has several possible consequences. The exact clinical implications are not entirely determined, but periprosthetic fractures and more challenging revision surgery are recognized problems. In a revision setting it is favourable to have good proximal bone stock to achieve primary stability of the implant. Peroperative fracture and compromised stability of the implant may be a potential problem in stress-shielded bone. Furthermore, already stress-shielded bone in the proximal femur may give wear debris easier access to the interface between implant and bone, resulting in further osteolysis. Short-term results for short-stemmed implants are encouraging in some clinical papers, but most of the available implants lack long-time clinical documentation. Most papers on stress shielding are not randomized trials between long and short stems. There are a few reports of increased revision rate and challenging surgical procedures.
Uncemented prosthetic hip implants are dependent on excellent primary stability to achieve osseointegration and long-term stability. It is recognized that excessive micromotion at the bone-implant interface is associated with formation of a soft tissue and loosening of implants. Micromotion above 40μm leads to partial bone ingrowth, while values above 150μm completely inhibit bone ingrowth. The main concern in short femoral stems is that stability might be compromised. This might be due to the relatively less contact surface. There are no long term results on stability of short femoral stems available, but in vitro studies shows no significant reduction in stability of prostheses with comparable stem length to the Furlong Evolution.
Malpositioning may result in a discrepancy between the reconstructed and the native biomechanical anatomy of the hip. Altered biomechanical properties may influence the clinical outcome and survival of implants. It has been shown that horizontal femoral offset, increases significantly more using a short femoral stem compared to conventional femoral stems. Compared to the contralateral hip, horizontal femoral offset was significantly increased only when using short stems. Increased femoral offset increases the torsion forces along the stem, which in turn raises the need for primary stability to avoid micromotion. It is also shown that a short stem has a wider range of varus-valgus in the stem-shaft axis, On the other there were found no significant differences in biomechanical reconstruction of the hip when using a "broach only" short stem, or a "ream and broach" standard stem.
If there are significant differences in the biomechanical hip reconstruction, will this affect patient reported outcome?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Furlong Evolution femoral stem | Experimental | Device: Short stem hip arthroplasty (SHA)Short stem hip arthroplasty (SHA) using a Furlong Evolution femoral stem, and a Furlong H-A.C. Cortical Scree Fit (CSF) plus acetabular cup system. |
| Furlong H-A.C. femoral stem | Active comparator | Device: Total hip arthroplasty (THA)Total hip arthroplasty (THA) using a Furlong H-A.C. femoral stem, and a Furlong H-A.C. CSF plus acetabular cup system. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- receiving primary total hip arthroplasty due to osteoarthritis, posttraumatic arthritis, avascular necrosis, or developmental hip dysplasia (Crowe grade 1)
Key exclusion criteria (10 listed)
- osteoporosis
- pregnancy
- musculoskeletal problems compromising rehabilitation
- corticosteroid treatment
- dementia
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 |
|---|---|---|
| Short stem hip arthroplasty (SHA)Furlong Evolution femoral stem | Device | Furlong Evolution femoral stem |
| Total hip arthroplasty (THA)Furlong H-A.C. femoral stem | Device | Furlong H-A.C. femoral stem |
Primary outcome
Change in periprosthetic bone mineral density (BMD)
Time frame: 2 years
Postoperative change in BMD following bone remodelling measured by dual-energy x-ray absorptiometry (DXA)
5 secondary outcomes
Migration of femoral stem
Time frame: 2 years
Biomechanical reconstruction of hip anatomy
Time frame: 2 years
Hip disability osteoarthritis outcome score (HOOS)
Time frame: 2 years
Harris hip score
Time frame: 2 years
Health-related quality of life (EQ-5D).
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- 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.
Olav Foss, md phd study director
St. Olavs Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Short stem hip arthroplasty (SHA) and Total hip arthroplasty (THA) in people with Osteoarthritis, Hip, run by St. Olavs Hospital.
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 10 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: withdrawn, as of the sponsor's last update on 12 Dec 2019. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in periprosthetic bone mineral density (BMD) (time frame: 2 years). 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 12 Dec 2019.