Aseptic Loosening of the Hip ProsthesisPhase 2NCT00658268
Bisphosphonates and Impaction Grafting in Hip Revision
A Phase 2 study testing Clodronate in people with Aseptic Loosening of the Hip Prosthesis, run by Region Skane at 1 site in Sweden.
Trial summary
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Aseptic Loosening of the Hip Prosthesis
- What is being tested?
- Clodronate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to 1 Aug 2017
- Phase
- Phase 2
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique
- Obtained informed consent
- Pregnancy excluded in women of childbearing age
Who cannot join
- Patients with known renal disease or S-creatinine >175 mcmol/L
- Patients with S-calcium 2.75 mmol/L
- Patients with diagnosed Rheumatoid arthritis
- Patients with active primary hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.
Read the detailed description
Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.
We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.
- Conditions
- Aseptic Loosening of the Hip Prosthesis
- Being tested
- Clodronate, Placebo
- Keywords
- Surgical procedures operative, Prosthesis implantation, Arthroplasty replacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClodronateDrug
60 mg/ml, 10 ml, single dose mixed in bone graft at operation
PlaceboDrug
10 ml, single dose mixed in bone graft at operation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Clodronate |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)
Measured: 12 months
Secondary outcomes (1)
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startMar 2008
- Primary completion1 Aug 2017
- Study completion1 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aseptic Loosening of the Hip ProsthesisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Magnus Tagil, MD, PhD, Principal investigator, Department of Orthopaedics, Lund University Hospital,Lund, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00658268
- Sponsor's protocol ID
- NKOISR10001
- Other IDs
- EudraCT2006-006439-39
- Status last verified
- Aug 2017
- First submitted
- 9 Apr 2008
- Last updated
- 15 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bisphosphonates and Impaction Grafting in Hip Revision Evaluated With Radiostereophotogrametri. A Randomized, Double-blind Study in Patients Operated for Aseptic Loosening and Osteolysis.
- ClinicalTrials.gov ID
- NCT00658268
- Acronym / sponsor ID
- NKOISR10001
- Conditions
- Aseptic Loosening of the Hip Prosthesis
- Keywords
- Surgical procedures operative, Prosthesis implantation, Arthroplasty replacement
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 1 Aug 2017 (actual)
- First posted
- 14 Apr 2008 (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.
The primary focus of this study is to investigate whether increased bone density of the graft in revision arthroplasty of the hip can cause a decreased micromotion of the implant relative to the femur.
Detailed description
Morsellized compacted bone allograft can be used for revision arthroplasty of the hip. Treating the graft locally with an antiresorptive substance such as a bisphosphonate has decreased the graft resorption in animal studies and led to a remained bone density in a human series of 16 patients. In the present study we investigate if this increased bone density of the graft also causes a decreased micromotion of the implant relative the femur. 36 patients are planned to participate in a 1:1 randomized and prospective study comparing the bisphosphonate Clodronate to saline. Primary outcome will be micromotion over the first year but also secondary parameters such as late micromotion (between 12 and 24 months), re-loosening subjective outcome and safety.
We hypothesize that rinsing the graft in a bisphosphonate solution prevents its resorption and therefore may reduce the risk of mechanical failure. Patients are followed with radiograms, RSA (radiostereography) preop, postop, at 6 weeks, at 12 and 24 months and subjective months and subjective parameters including Womac and SF 12. The treatment is simple, cheap and appears virtually risk-free.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Clodronate |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with aseptic loosening and osteolysis scheduled for hip revision using allograft and impaction technique
- Obtained informed consent
- Pregnancy excluded in women of childbearing age
Key exclusion criteria (4 listed)
- Patients with known renal disease or S-creatinine >175 mcmol/L
- Patients with S-calcium 2.75 mmol/L
- Patients with diagnosed Rheumatoid arthritis
- Patients with active primary hyperparathyroidism
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 |
|---|---|---|
| Clodronate60 mg/ml, 10 ml, single dose mixed in bone graft at operation | Drug | 1 |
| Placebo10 ml, single dose mixed in bone graft at operation | Drug | 2 |
Primary outcome
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months)
Time frame: 12 months
1 secondary outcome
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (late micromotion)
Time frame: 12-24 months
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 15 Aug 2017.
Related trials for Aseptic Loosening of the Hip Prosthesis
RecruitingObservational study
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Revision Hip Arthroplasty, Aseptic Loosening of Prosthetic Joint
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.
Magnus Tagil, MD, PhD principal investigator
Department of Orthopaedics, Lund University Hospital,Lund, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clodronate in people with Aseptic Loosening of the Hip Prosthesis, run by Region Skane at 1 site in Sweden.
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 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 15 Aug 2017. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Decrease of prosthetic micromotion from 2.7 mm to 1.7 mm as measured by RSA (0-24 months) (time frame: 12 months). 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 15 Aug 2017.