Hip ArthrosisEarly Phase 1NCT03803839
Locally Administered Clodronate in the Prevention of Aseptic Implant Loosening
A Early Phase 1 study testing Clodronate and Saline in people with Hip Arthrosis, run by University of Oulu.
Trial summary
Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant. Read more about this study
- Who is it for?
- Ages Up to 73 years
- Conditions the study is for
- Hip Arthrosis
- What is being tested?
- Clodronate and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- 26 Mar 2004to 12 Mar 2014
- Phase
- Early Phase 1
- 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 Up to 73 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- hip arthrosis and
- a primary THA was planned
Who cannot join
- renal insufficiency
- hypercalcemia
- malignant tumors
- contemporaneously treatment with another bisphosphonate or aminoglycoside
About this study
Official title: Could the Intra-operative Clodronate Rinsing Improve the Integration of the Femoral Stem in a Prospective, Double-blinded, Randomized, Placebo-controlled Clinical RSA-study
Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant.
Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing packages were labeled only with the code from the pharmacy of the hospital. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris hip score (HHS).
The purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary THA.
- Conditions
- Hip Arthrosis
- Being tested
- Clodronate, Saline
- Keywords
- RSA, DXA, Bisphosphonates, Migration of stem, Aseptic loosening of 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.
ClodronateDrug
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Clodronate | Active comparator | 1 mM clodronate (60 mg in 1000 ml saline) was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the clodronate solution. The time for rinsing was about one minute. Receives: Drug: Clodronate |
| Saline | Placebo comparator | 1000 ml saline was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the saline solution. The time for rinsing was about one minute. Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal total point motion (MTPM) - migration of the femoral stem
It represents the length of the translation vector of the point in a rigid body that has the greatest motion. It can only have positive values, and is not normally distributed. The reason for using MTPM is that in many cases, motion implies a biological effect of some kind and this effect is liable to be greatest at the point of maximum motion. The parameter has been measured by RSA-methods, which is an accurate method of determining the migration and wear of orthopaedic implants: it determine the precise location of two distinct objects relative to each other in three dimension such as the relative position of the femoral component and the proximal femur. In radiostereometric analysis the position in space of the original object is reconstructed from a two dimensional x-ray film using tantalum beads. Movement between segments is then calculated by localizing each segment in a coordinate system. Lower values represent a better outcome.
Measured: 0 to 24 months
Secondary outcomes (1)
Bone mineral density (BMD) in 7 Gruen zones
BMD was measured by dual-energy X-ray absorptiometry, DXA. In clinical use, precision errors are < 5 %. To evaluate the horizontal linear distribution of the BMD, seven Gruen zones, peri-prosthetic sub-regions of interest, ROI (region of interest) were calculated by the software on the anteroposterior view of the proximal femur. The value of BMD is g/cm2 and it estimates the strength of the bone. Higher values/lesser decrease in values represent a better outcome.
Measured: 0 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start26 Mar 2004
- Primary completion12 Mar 2014
- Study completion12 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthrosisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this prospective, double-blinded, randomized, placebo-controlled clinical trial with two years follow-up period the investigators rinsed the proximal intramedullary cavity of the femur with either clodronate (60 mg clodronate in 1000 ml saline) or saline (1000 ml saline) prior to the application of the femoral stem.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803839
- Sponsor's protocol ID
- Ei tiedossa
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome data will be made available.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Could the Intra-operative Clodronate Rinsing Improve the Integration of the Femoral Stem in a Prospective, Double-blinded, Randomized, Placebo-controlled Clinical RSA-study
- ClinicalTrials.gov ID
- NCT03803839
- Acronym / sponsor ID
- Ei tiedossa
- Conditions
- Hip Arthrosis
- Keywords
- RSA, DXA, Bisphosphonates, Migration of stem, Aseptic loosening of prosthesis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 26 Mar 2004 (actual)
- Primary completion
- 12 Mar 2014 (actual)
- Study completion
- 12 Mar 2014 (actual)
- First posted
- 15 Jan 2019 (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.
Periprosthetic bone-loss after total hip arthroplasty (THA), detected as an early migration of the prosthesis, may predict later loosening. The investigators hypothesized that by reducing bone resorption after THA with bisphosphonates, it might be possible to achieve better early fixation of the implant.
Nineteen patients suffering arthrosis were recruited to a prospective, double-blinded, randomized, placebo-controlled clinical pilot trial. Patients were operated with an uncemented Bimetric stem with tantalum markers, the acetabular cup and liner were chosen by the surgeon. The femoral proximal intramedullary canal was rinsed with 1mM (millimole) clodronate, that was done by adding the clodronate to the 1000 ml 0.9% NaCl (sodium chloride) in nine patients and rinsing solution was the pure 0.9% NaCl for 10 patients. These rinsing packages were labeled only with the code from the pharmacy of the hospital. These patients were followed for two years using radiostereometric analysis (RSA), dual energy x-ray absorptiometry (DXA) and the Harris hip score (HHS).
The purpose of the investigator's study was to examine whether the local intraoperative administration of clodronate could reduce periprosthetic bone loss and further stem migration after primary THA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- In this prospective, double-blinded, randomized, placebo-controlled clinical trial with two years follow-up period the investigators rinsed the proximal intramedullary cavity of the femur with either clodronate (60 mg clodronate in 1000 ml saline) or saline (1000 ml saline) prior to the application of the femoral stem.
| Arm | Type | Receives |
|---|---|---|
| Clodronate | Active comparator | Drug: Clodronate1 mM clodronate (60 mg in 1000 ml saline) was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the clodronate solution. The time for rinsing was about one minute. |
| Saline | Placebo comparator | Drug: Saline1000 ml saline was used intraoperatively during total hip arthroplasty: before installation of the prosthesis, the rinsing was performed with pulsatile lavage using the saline solution. The time for rinsing was about one minute. |
Who may qualify
- Ages
- Up to 73 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- hip arthrosis and
- a primary THA was planned
Key exclusion criteria (4 listed)
- renal insufficiency
- hypercalcemia
- malignant tumors
- contemporaneously treatment with another bisphosphonate or aminoglycoside
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 |
|---|---|---|
| Clodronate | Drug | Clodronate |
| Saline | Drug | Saline |
Primary outcome
Maximal total point motion (MTPM) - migration of the femoral stem
Time frame: 0 to 24 months
It represents the length of the translation vector of the point in a rigid body that has the greatest motion. It can only have positive values, and is not normally distributed. The reason for using MTPM is that in many cases, motion implies a biological effect of some kind and this effect is liable to be greatest at the point of maximum motion. The parameter has been measured by RSA-methods, which is an accurate method of determining the migration and wear of orthopaedic implants: it determine the precise location of two distinct objects relative to each other in three dimension such as the relative position of the femoral component and the proximal femur. In radiostereometric analysis the position in space of the original object is reconstructed from a two dimensional x-ray film using tantalum beads. Movement between segments is then calculated by localizing each segment in a coordinate system. Lower values represent a better outcome.
1 secondary outcome
Bone mineral density (BMD) in 7 Gruen zones
Time frame: 0 to 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 18 Jan 2019.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome data will be made available.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clodronate and Saline in people with Hip Arthrosis, run by University of Oulu.
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 2 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 18 Jan 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Maximal total point motion (MTPM) - migration of the femoral stem (time frame: 0 to 24 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 18 Jan 2019.