Osteoarthritis of the KneePhase 4NCT01488175
Clinical and Stereoradiological Comparison of the Results After Primary Cemented Total Knee Arthroplasty Inserted With or Without the Use of a Tourniquet
A Phase 4 study testing tourniquet and no tourniquet in people with Osteoarthritis of the Knee, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis of the Knee
- What is being tested?
- tourniquet and no tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Jan 2015
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis og osteoarthritis of the knee
- patients must be 18 years or older
- patients must understand and speak danish
- must be able to give signed consent
Who cannot join
- severe medical illness
- documented osteoporosis
- rheumatoid arthritis
- prior surgery in the knee
- neuropathy
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
Hvidovre, 2650
About this study
Official title: Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet
The purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.
- Conditions
- Osteoarthritis of the Knee
- Being tested
- tourniquet, no tourniquet
- Keywords
- TKA, RSA, Tourniquet, Arthroplasty, Knee
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tourniquetProcedure or surgery
a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
no tourniquetProcedure or surgery
a tourniquet around the thigh is not used during insertion of the TKA
| Study group | Role | What they receive |
|---|---|---|
| with tourniquet | Active comparator | Not described Receives: Procedure: tourniquet |
| without tourniquet | Placebo comparator | Not described Receives: Procedure: no tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
migration of the prosthesis in millimeters assessed vith RSA.
does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?
Measured: 2 years
Secondary outcomes (3)
postoperative pain.
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Measured: 2 years
Patient satisfaction (VAS-scale)
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
Measured: 2 years
Knee range of motion (degrees)
Does the use of a tourniquet affect postoperative pain, patient satisfaciton and knee range of motion
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 posted8 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionJan 2015 (estimated)
- Study completionJan 2015 (estimated)
Why it stopped: Funding problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the KneeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Morten Grove Thomsen, Hvidovre University Hospital
- Investigators
- Anders Troelsen, M.D, Ph.D, Study chair, Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01488175
- Sponsor's protocol ID
- H-2-2011-100
- Status last verified
- Mar 2015
- First submitted
- 2 Dec 2011
- Last updated
- 18 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Stereoradiological Comparison of the Results After Primary TKA Inserted With or Without the Use of a Tourniquet
- ClinicalTrials.gov ID
- NCT01488175
- Acronym / sponsor ID
- H-2-2011-100
- Conditions
- Osteoarthritis of the Knee
- Keywords
- TKA, RSA, Tourniquet, Arthroplasty, Knee
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (estimated)
- Study completion
- Jan 2015 (estimated)
- First posted
- 8 Dec 2011 (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 purpose of this study is to investigate if the use of a tourniquet during insertion of a cemented primary total knee arthroplasty will influence clinical and radiological (measured with RSA X-ray technique) outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with tourniquet | Active comparator | Procedure: tourniquet |
| without tourniquet | Placebo comparator | Procedure: no tourniquet |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinical diagnosis og osteoarthritis of the knee
- patients must be 18 years or older
- patients must understand and speak danish
- must be able to give signed consent
Key exclusion criteria (5 listed)
- severe medical illness
- documented osteoporosis
- rheumatoid arthritis
- prior surgery in the knee
- neuropathy
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 |
|---|---|---|
| tourniqueta tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment | Procedure or surgery | with tourniquet |
| no tourniqueta tourniquet around the thigh is not used during insertion of the TKA | Procedure or surgery | without tourniquet |
Primary outcome
migration of the prosthesis in millimeters assessed vith RSA.
Time frame: 2 years
does the use of a tourniquet around the thigh during insertion of a primary TKA affect postoperative migration of the prosthesis?
3 secondary outcomes
postoperative pain.
Time frame: 2 years
Patient satisfaction (VAS-scale)
Time frame: 2 years
Knee range of motion (degrees)
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 18 Mar 2015.
Related trials for Osteoarthritis of the Knee
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
Anders Troelsen, M.D, Ph.D study chair
Dept. of Orthopedics, University Hospital of Hvidovre, Denmark.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing tourniquet and no tourniquet in people with Osteoarthritis of the Knee, run by Hvidovre University Hospital at 1 site in Denmark.
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 4 inclusion and 5 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 18 Mar 2015. 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 Denmark. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
migration of the prosthesis in millimeters assessed vith RSA. (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 18 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.