Muscles IschemiaNCT02475603
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty
A study testing Total knee arthroplasty in people with Muscles Ischemia, run by Universitätsmedizin Mannheim at 1 site in Germany.
Trial summary
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty: WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscles Ischemia
- What is being tested?
- Total knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Jan 2016
- 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 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age = 55-85 years
- Osteoarthritis of knee joint (degree III or IV)
- Physical status (ASA I or II)
- Body mass index < 45 kg/m²
- Written informed consent
Who cannot join
- Age <55 or > 85years
- Osteoarthritis knee joint (degree I or II)
- Physical status (ASA III or IV)
- Body mass index ≥ 45 kg/m²
- Unable to provide written consent
- Malignant disease
Show all 17Show fewer
- Rheumatoid disease
- Infectious disease
- Coagulation disorder
- History of deep vein thrombosis or pulmonary embolism
- Peripheral arterial disease
- Immune deficiency
- Medication (Glucocorticoid, Aspirin, Heparin, Cumardine, Wafarin)
- Neurological dysfunction
- Liver insufficiency
- Coronary heart disease
- Immobility
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
UMM
Mannheim, Badenwürtemberg, 68167
Ahmed Jawhar, Dr., jawhar_ahmed@yahoo.de
About this study
Official title: Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:
WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis
Read the detailed description
Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis
- Conditions
- Muscles Ischemia
- Being tested
- Total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Total knee arthroplasty
| Study group | Role | What they receive |
|---|---|---|
| tourniquet | Experimental | Total knee arthroplasty will be performed with tourniquet Receives: Procedure: Total knee arthroplasty |
| non-tourniquet | Experimental | Total knee arthroplasty will be performed without tourniquet Receives: Procedure: Total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemical Data
Measurement of intracellular proteolytic activity
Measured: During operation 60 min Ischemia/Shame-Ischemia Time
Secondary outcomes (5)
Bloodloss
Measured: 1 week postoperative
Complications
Measured: 6 months postoperative
Clinical Scores
WOMAC-Score, Knee-Score
Measured: 6 months postoperative
Radiographic Scores
Prosthesis Position on radiographs
Measured: 1 Week postoperative
Electrophysiological Evaluation of the N. femoralis
Nerve function analysis
Measured: 1 Week postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2015 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscles IschemiaStudies 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ahmed Jawhar, Universitätsmedizin Mannheim
- Investigators
- Udo Obertacke, Prof. Dr., Study director, UMM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02475603
- Sponsor's protocol ID
- 2012-334N-MA
- Status last verified
- Sep 2012
- First submitted
- 10 Jun 2015
- Last updated
- 19 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Girard N. Evidence appraisal of Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13. http://www.josr-online.com/content/9/1/13. Accessed May 30, 2014. AORN J. 2014 Aug;100(2):224-8. doi: 10.1016/j.aorn.2014.06.003. No abstract available.
PubMed 25219028Jawhar A, Skeirek D, Stetzelberger V, Kollowa K, Obertacke U. No effect of tourniquet in primary total knee arthroplasty on muscle strength, functional outcome, patient satisfaction and health status: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1045-1054. doi: 10.1007/s00167-019-05646-5. Epub 2019 Aug 1.
PubMed 31372679
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Biochemical and Neurophysiological Consequences of Intraoperative
- ClinicalTrials.gov ID
- NCT02475603
- Acronym / sponsor ID
- 2012-334N-MA
- Conditions
- Muscles Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jan 2016 (estimated)
- First posted
- 19 Jun 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.
Clinical, Biochemical and Neurophysiological Consequences of Intraoperative Tourniquet During Total Knee Arthroplasty:
WOMAC-Score Knee-Score Radiographic Evaluations and Scoring System Biochemical muscle biopsy analysis
Detailed description
Biochemistry: Analysis of the muscles biopsies Clinical: Bloodloss, Complications, WOMAC-Score, Knee-Score Radiographics: Evaluations and Scoring System Neurophysiology Evaluation of N. femoralis
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tourniquet | Experimental | Procedure: Total knee arthroplastyTotal knee arthroplasty will be performed with tourniquet |
| non-tourniquet | Experimental | Procedure: Total knee arthroplastyTotal knee arthroplasty will be performed without tourniquet |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age = 55-85 years
- Osteoarthritis of knee joint (degree III or IV)
- Physical status (ASA I or II)
- Body mass index < 45 kg/m²
- Written informed consent
Key exclusion criteria (17 listed)
- Age <55 or > 85years
- Osteoarthritis knee joint (degree I or II)
- Physical status (ASA III or IV)
- Body mass index ≥ 45 kg/m²
- Unable to provide written consent
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 |
|---|---|---|
| Total knee arthroplastyTotal knee arthroplasty | Procedure or surgery | non-tourniquet, tourniquet |
Primary outcome
Biochemical Data
Time frame: During operation 60 min Ischemia/Shame-Ischemia Time
Measurement of intracellular proteolytic activity
5 secondary outcomes
Bloodloss
Time frame: 1 week postoperative
Complications
Time frame: 6 months postoperative
Clinical Scores
Time frame: 6 months postoperative
Radiographic Scores
Time frame: 1 Week postoperative
Electrophysiological Evaluation of the N. femoralis
Time frame: 1 Week postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Background: PubMed 25219028Girard N. Evidence appraisal of Zhang W, Li N, Chen S, Tan Y, Al-Aidaros M, Chen L. The effects of a tourniquet used in total knee arthroplasty: a meta-analysis. J Orthop Surg Res. 2014;9(1):13. http://www.josr-online.com/content/9/1/13. Accessed May 30, 2014. AORN J. 2014 Aug;100(2):224-8. doi: 10.1016/j.aorn.2014.06.003. No abstract available.
- Derived from this study: PubMed 31372679Jawhar A, Skeirek D, Stetzelberger V, Kollowa K, Obertacke U. No effect of tourniquet in primary total knee arthroplasty on muscle strength, functional outcome, patient satisfaction and health status: a randomized clinical trial. Knee Surg Sports Traumatol Arthrosc. 2020 Apr;28(4):1045-1054. doi: 10.1007/s00167-019-05646-5. Epub 2019 Aug 1.
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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.
Udo Obertacke, Prof. Dr. study director
UMM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty in people with Muscles Ischemia, run by Universitätsmedizin Mannheim at 1 site in Germany.
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 5 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 19 Jun 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Jawhar, Dr (0621-3834500 ext. umm, jawhar_ahmed@yahoo.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemical Data (time frame: During operation 60 min Ischemia/Shame-Ischemia Time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02475603, which also lists 2 linked publications.
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 19 Jun 2015.