OsteoarthritisNCT02358447
SPECT-CT for Assessment of Total Knee Arthroplasty in Navigated and Non-navigated Total Knee Arthroplasty
An observational study of Osteoarthritis and X-rays; Effects, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
Trial summary
By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, X-rays; Effects
- What is being tested?
- TKR
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2010to 23 Oct 2018
- 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: Paitents before and after total knee replacement surgery
Who may be able to join
- Total Knee prosthesis (primary)
- >18 years
Who cannot join
- pregnancy
- lactating women
- endocrine diseases
- tumour diseases
- posttraumatic osteoarthritis of the knee
- previous infection of the knee
- medicaments which influence the metabolism of the bone
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Baselland, Bruderholz
Bruderholz, Basel-Landschaft, 4101
About this study
Official title: SPECT-CT for Assessment of Patients Before and After Navigated and Conventional Total Knee Arthroplasty.
By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome.
Read the detailed description
With SPECT/CT we want to controll the clinical outcome of patients who underwent a navigated or a non-navigated TKR.
- Conditions
- Osteoarthritis, X-rays; Effects
- Being tested
- TKR
- Keywords
- total knee arthroplasty, total knee prothesis, Spectrometry, X-Ray Emission, SPECT/CT, measurement of TKA component position
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKRProcedure or surgery
non-navigated versus computer-navigated total knee replacement
| Study group | Role | What they receive |
|---|---|---|
| SPECT/CT before/after navigated TKR | SPECT/CT in patients before and after navigated TKR (assessment of bone tracer uptake, 3D CT component position) Receives: Procedure: TKR | |
| SPECT/CT before/after conventional TKR | SPECT/CT in patients before and after conventional TKR (assessment of bone tracer uptake, 3D CT component position) Receives: Procedure: TKR |
What is being measured
The primary outcome is the main question the study is designed to answer.
which operation method is the best in terms of outcome and SPECT/CT imaging
Measured: five years
Secondary outcomes (1)
Improvement in the post-treatment
Measured: five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startApr 2010
- Primary completionJul 2017
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Tobias Hirschmann, Kantonsspital Baselland Bruderholz
- Investigators
- MIchael T. Hirschmann, MD, Principal investigator, Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358447
- Sponsor's protocol ID
- SPECT/CT-TKR_001_MH
- Other IDs
- 380/09
- Status last verified
- Oct 2018
- First submitted
- 2 Jan 2015
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT-CT for Assessment of Patients Before and After Navigated and Conventional Total Knee Arthroplasty.
- ClinicalTrials.gov ID
- NCT02358447
- Acronym / sponsor ID
- SPECT/CT-TKR_001_MH
- Conditions
- Osteoarthritis, X-rays; Effects
- Keywords
- total knee arthroplasty, total knee prothesis, Spectrometry, X-Ray Emission, SPECT/CT, measurement of TKA component position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2017 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 9 Feb 2015 (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.
By the comparison of two operation methods navigated and non-navigated TKR with SPECT/CT we want to show wich method has the better outcome.
Detailed description
With SPECT/CT we want to controll the clinical outcome of patients who underwent a navigated or a non-navigated TKR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SPECT/CT before/after navigated TKR | – | Procedure: TKRSPECT/CT in patients before and after navigated TKR (assessment of bone tracer uptake, 3D CT component position) |
| SPECT/CT before/after conventional TKR | – | Procedure: TKRSPECT/CT in patients before and after conventional TKR (assessment of bone tracer uptake, 3D CT component position) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Paitents before and after total knee replacement surgery
Key inclusion criteria (2 listed)
- Total Knee prosthesis (primary)
- >18 years
Key exclusion criteria (7 listed)
- pregnancy
- lactating women
- endocrine diseases
- tumour diseases
- posttraumatic osteoarthritis of the knee
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 |
|---|---|---|
| TKRnon-navigated versus computer-navigated total knee replacement | Procedure or surgery | SPECT/CT before/after conventional TKR, SPECT/CT before/after navigated TKR |
Primary outcome
which operation method is the best in terms of outcome and SPECT/CT imaging
Time frame: five years
1 secondary outcome
Improvement in the post-treatment
Time frame: five years
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 23 Oct 2018.
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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.
MIchael T. Hirschmann, MD principal investigator
Dept. of Orthop. Surgery and Traumatology, Kantonsspital Baselland - Bruderholz, Unitverstity of Basel, Switzerland
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 X-rays; Effects, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
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 7 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 23 Oct 2018. 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 Switzerland. 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?
which operation method is the best in terms of outcome and SPECT/CT imaging (time frame: five 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 23 Oct 2018.