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Not yet recruitingNCT07831941Updated Sep 22, 2026

Effect of Tourniquet Use on the Pivot Shift Test

An interventional study of Thigh Tourniquet Inflation in Anterior Cruciate Ligament Injury, sponsored by Umraniye Education and Research Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Umraniye Education and Research Hospital · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Not applicable
Ages
16 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Anterior Cruciate Ligament Injury

Keywords

  • Pivot Shift Test
  • Tourniquet
  • Anterior Cruciate Ligament Reconstruction
  • Rotational Knee Instability
  • Knee Instability
03

In context

Anterior Cruciate Ligament Injuries

625 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 192 are open to participants now.

This study's planned enrollment of 34 is below the median of 56 across 458 interventional studies indexed under Anterior Cruciate Ligament Injuries.

Browse Anterior Cruciate Ligament Injuries studies →

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 61 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with anterior cruciate ligament (ACL) rupture.
  • Age between 16 and 65 years.

Exclusion criteria

Exclusion Criteria:

  • Patients with multiligament knee injuries.
  • Patients with fractures extending into the knee joint.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    Tourniquet Assessment Group

    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.

    Procedure: Thigh Tourniquet Inflation

Interventions

  • ProcedureThigh Tourniquet Inflation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Intraoperatively, immediately before and after tourniquet inflation

07

Study locations

1 site
08

References and documents

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 29568784 ↗
  • Porter 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07831941
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Mesut Akkaya (Orthopaedics and Traumatology Specialist, Umraniye Education and Research Hospital) — Principal investigator
First posted
Sep 21, 2026
Start date
Sep 16, 2026 (estimated)
Primary completion
Nov 30, 2026 (estimated)
Completion
Nov 30, 2026 (estimated)
Last update
Sep 22, 2026

Study contacts

Mesut AKKAYA, MD
Contact
mesutakkaya2010@hotmail.com
+90 505 244 15 25
Mesut Akkaya
principal investigator · Umraniye Education and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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