Anterior Cruciate Ligament InjuryNCT07831941
Effect of Tourniquet Use on the Pivot Shift Test
A study testing Thigh Tourniquet Inflation in people with Anterior Cruciate Ligament Injury, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective study will evaluate whether tourniquet inflation affects the results of the pivot shift test in patients undergoing anterior cruciate ligament (ACL) reconstruction. The pivot shift test is commonly used to assess rotational instability of the knee in patients with ACL injury. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Anterior Cruciate Ligament Injury
- What is being tested?
- Thigh Tourniquet Inflation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Sep 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with anterior cruciate ligament (ACL) rupture.
- Age between 16 and 65 years.
Who cannot join
- Patients with multiligament knee injuries.
- Patients with fractures extending into the knee joint.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Umraniye Education and Research Hospital
Istanbul, Umraniye, 34764
Mesut AKKAYA, MD, +90 505 244 15 25, mesutakkaya2010@hotmail.com
About this study
Official title: Evaluation of the Effect of Tourniquet Use on the Pivot Shift Test
This prospective study will evaluate whether tourniquet inflation affects the results of the pivot shift test in patients undergoing anterior cruciate ligament (ACL) reconstruction. The pivot shift test is commonly used to assess rotational instability of the knee in patients with ACL injury.
In each participant, the pivot shift test will be performed under anesthesia before and after inflation of the thigh tourniquet, allowing the two conditions to be compared within the same patient. The study aims to determine whether tourniquet use changes the findings of the pivot shift examination.
Understanding the possible influence of tourniquet inflation may help standardize intraoperative assessment of rotational knee instability and improve interpretation of the pivot shift test during ACL surgery.
Read the detailed description
Anterior cruciate ligament (ACL) deficiency may result in both anterior and rotational instability of the knee. The pivot shift test is commonly used to assess rotational instability and is frequently performed under anesthesia during ACL reconstruction. However, intraoperative factors may influence the findings of the examination.
This prospective study is designed to investigate whether inflation of a thigh tourniquet affects the pivot shift test. Each participant will serve as their own control. After induction of anesthesia, the pivot shift test will be performed before tourniquet inflation and repeated after tourniquet inflation under the same operative conditions. The findings obtained under the two conditions will be compared to determine whether tourniquet inflation influences the assessment of rotational knee instability.
The study may help clarify whether tourniquet status should be standardized when the pivot shift test is performed intraoperatively during ACL reconstruction.
- Conditions
- Anterior Cruciate Ligament Injury
- Being tested
- Thigh Tourniquet Inflation
- Keywords
- Pivot Shift Test, Tourniquet, Anterior Cruciate Ligament Reconstruction, Rotational Knee Instability, Knee Instability
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thigh Tourniquet InflationProcedure or surgery
After the baseline pivot shift test is performed under anesthesia, the thigh tourniquet is inflated and the pivot shift test is repeated during the same surgical procedure. The findings before and after tourniquet inflation are compared within the same participant.
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet Assessment Group | Experimental | Participants undergoing anterior cruciate ligament reconstruction will undergo the pivot shift test under anesthesia before and after inflation of the thigh tourniquet during the same surgical procedure. Each participant will serve as their own control, and the paired assessments will be compared to determine whether tourniquet inflation influences the pivot shift test findings. Receives: Procedure: Thigh Tourniquet Inflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pivot Shift Test Grade After Tourniquet Inflation
The pivot shift test will be performed under anesthesia immediately before and after inflation of the thigh tourniquet. Pivot shift grade will be recorded using the standard clinical grading system. Pre-inflation and post-inflation grades will be compared within the same participant to determine whether tourniquet inflation changes the degree of rotational knee instability. Higher grades indicate greater rotational instability.
Measured: Intraoperatively, immediately before and after tourniquet inflation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start16 Sep 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (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 Anterior Cruciate Ligament InjuryStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants undergo intraoperative pivot shift testing twice under anesthesia: first before thigh tourniquet inflation and then after tourniquet inflation. Each participant serves as their own control, and the paired measurements are compared to assess the effect of tourniquet inflation on the pivot shift test.
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mesut Akkaya, Umraniye Education and Research Hospital
- Investigators
- Mesut Akkaya, Principal investigator, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07831941
- Sponsor's protocol ID
- UMR-ORTHO-2025-142
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no plan has been established for sharing de-identified participant-level data outside the study team.
Publications
Lichtenberg MC, Koster CH, Teunissen LPJ, Oosterveld FGJ, Harmsen AMK, Haverkamp D, Hoornenborg D, Berg RP, Bloemers FW, Faber IR. Does the Lever Sign Test Have Added Value for Diagnosing Anterior Cruciate Ligament Ruptures? Orthop J Sports Med. 2018 Mar 16;6(3):2325967118759631. doi: 10.1177/2325967118759631. eCollection 2018 Mar.
PubMed 29568784Porter M, Shadbolt B. Modified Iliotibial Band Tenodesis Is Indicated to Correct Intraoperative Residual Pivot Shift After Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Apr;48(5):1069-1077. doi: 10.1177/0363546520910148. Epub 2020 Mar 17.
PubMed 32182127
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Tourniquet Use on the Pivot Shift Test
- ClinicalTrials.gov ID
- NCT07831941
- Acronym / sponsor ID
- UMR-ORTHO-2025-142
- Conditions
- Anterior Cruciate Ligament Injury
- Keywords
- Pivot Shift Test, Tourniquet, Anterior Cruciate Ligament Reconstruction, Rotational Knee Instability, Knee Instability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 16 Sep 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Sep 2026 (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.
This prospective study will evaluate whether tourniquet inflation affects the results of the pivot shift test in patients undergoing anterior cruciate ligament (ACL) reconstruction. The pivot shift test is commonly used to assess rotational instability of the knee in patients with ACL injury.
In each participant, the pivot shift test will be performed under anesthesia before and after inflation of the thigh tourniquet, allowing the two conditions to be compared within the same patient. The study aims to determine whether tourniquet use changes the findings of the pivot shift examination.
Understanding the possible influence of tourniquet inflation may help standardize intraoperative assessment of rotational knee instability and improve interpretation of the pivot shift test during ACL surgery.
Detailed description
Anterior cruciate ligament (ACL) deficiency may result in both anterior and rotational instability of the knee. The pivot shift test is commonly used to assess rotational instability and is frequently performed under anesthesia during ACL reconstruction. However, intraoperative factors may influence the findings of the examination.
This prospective study is designed to investigate whether inflation of a thigh tourniquet affects the pivot shift test. Each participant will serve as their own control. After induction of anesthesia, the pivot shift test will be performed before tourniquet inflation and repeated after tourniquet inflation under the same operative conditions. The findings obtained under the two conditions will be compared to determine whether tourniquet inflation influences the assessment of rotational knee instability.
The study may help clarify whether tourniquet status should be standardized when the pivot shift test is performed intraoperatively during ACL reconstruction.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants undergo intraoperative pivot shift testing twice under anesthesia: first before thigh tourniquet inflation and then after tourniquet inflation. Each participant serves as their own control, and the paired measurements are compared to assess the effect of tourniquet inflation on the pivot shift test.
| Arm | Type | Receives |
|---|---|---|
| Tourniquet Assessment Group | Experimental | Procedure: Thigh Tourniquet InflationParticipants undergoing anterior cruciate ligament reconstruction will undergo the pivot shift test under anesthesia before and after inflation of the thigh tourniquet during the same surgical procedure. Each participant will serve as their own control, and the paired assessments will be compared to determine whether tourniquet inflation influences the pivot shift test findings. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with anterior cruciate ligament (ACL) rupture.
- Age between 16 and 65 years.
Key exclusion criteria (2 listed)
- Patients with multiligament knee injuries.
- Patients with fractures extending into the knee joint.
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 |
|---|---|---|
| Thigh Tourniquet InflationAfter the baseline pivot shift test is performed under anesthesia, the thigh tourniquet is inflated and the pivot shift test is repeated during the same surgical procedure. The findings before and after tourniquet inflation are compared within the same participant. | Procedure or surgery | Tourniquet Assessment Group |
Primary outcome
Change in Pivot Shift Test Grade After Tourniquet Inflation
Time frame: Intraoperatively, immediately before and after tourniquet inflation
The pivot shift test will be performed under anesthesia immediately before and after inflation of the thigh tourniquet. Pivot shift grade will be recorded using the standard clinical grading system. Pre-inflation and post-inflation grades will be compared within the same participant to determine whether tourniquet inflation changes the degree of rotational knee instability. Higher grades indicate greater rotational instability.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Background: PubMed 29568784Lichtenberg MC, Koster CH, Teunissen LPJ, Oosterveld FGJ, Harmsen AMK, Haverkamp D, Hoornenborg D, Berg RP, Bloemers FW, Faber IR. Does the Lever Sign Test Have Added Value for Diagnosing Anterior Cruciate Ligament Ruptures? Orthop J Sports Med. 2018 Mar 16;6(3):2325967118759631. doi: 10.1177/2325967118759631. eCollection 2018 Mar.
- Background: PubMed 32182127Porter M, Shadbolt B. Modified Iliotibial Band Tenodesis Is Indicated to Correct Intraoperative Residual Pivot Shift After Anterior Cruciate Ligament Reconstruction Using an Autologous Hamstring Tendon Graft: A Prospective Randomized Controlled Trial. Am J Sports Med. 2020 Apr;48(5):1069-1077. doi: 10.1177/0363546520910148. Epub 2020 Mar 17.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no plan has been established for sharing de-identified participant-level data outside the study team.
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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.
Mesut Akkaya principal investigator
Umraniye Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thigh Tourniquet Inflation in people with Anterior Cruciate Ligament Injury, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 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: opening soon, as of the sponsor's last update on 22 Sep 2026. 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 Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mesut AKKAYA, MD (+90 505 244 15 25, mesutakkaya2010@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pivot Shift Test Grade After Tourniquet Inflation (time frame: Intraoperatively, immediately before and after tourniquet inflation). 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 NCT07831941, 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 22 Sep 2026.