Tourniquet vs. no Tourniquet During High Tibial Osteotomy

NCT ID: NCT04992533

Last Updated: 2021-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-12-30

Brief Summary

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The purpose of this study is to correlate functional outcomes and perioperative complications with tourniquet use during high tibial osteotomy.

Detailed Description

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Tourniquet is widely used in orthopedic surgery, but its effect and safety in high tibial osteotomy have not been studied. This study evaluated the efficacy and safety of tourniquets by comparing different timing of use.Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Long-duration tourniquet

Tourniquets inflated before arthroscopic exploration and deflated after high tibial osteotomy

Group Type ACTIVE_COMPARATOR

Long-duration tourniquet

Intervention Type PROCEDURE

Tourniquet is used in arthroscopic exploration and high tibial osteotomy

Short-duration tourniquet

Tourniquet should be inflated before arthroscopic exploration and deflated immediately after the exploration

Group Type EXPERIMENTAL

Short-duration tourniquet

Intervention Type PROCEDURE

Tourniquet is only used for arthroscopic exploration

Interventions

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Long-duration tourniquet

Tourniquet is used in arthroscopic exploration and high tibial osteotomy

Intervention Type PROCEDURE

Short-duration tourniquet

Tourniquet is only used for arthroscopic exploration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1.Simple knee medial compartment osteoarthritis High tibial osteotomy.
* 2\. With varus deformity, medial proximal tibia angle \<85°
* 3\. Unilateral High tibial osteotomy
* 4\. Informed consent: Participants must be able to understand and voluntarily sign a written informed consent and follow the research protocol and interview process

Exclusion Criteria

* 1.Patients who underwent other knee surgery within 6 months
* 2.Preoperative combined anemia (Hb\<100g/l)
* 3.Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peilai Liu, MD

Role: STUDY_CHAIR

Qilu Hospital of Shandong University

Locations

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Qilu hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Songlin Li, MD

Role: CONTACT

053182166541

Peilai Liu, MD

Role: CONTACT

053182166541

Facility Contacts

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songlin Li, MD

Role: primary

15634057227

References

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Goel R, Rondon AJ, Sydnor K, Blevins K, O'Malley M, Purtill JJ, Austin MS. Tourniquet Use Does Not Affect Functional Outcomes or Pain After Total Knee Arthroplasty: A Prospective, Double-Blinded, Randomized Controlled Trial. J Bone Joint Surg Am. 2019 Oct 16;101(20):1821-1828. doi: 10.2106/JBJS.19.00146.

Reference Type BACKGROUND
PMID: 31626006 (View on PubMed)

Jawhar A, Stetzelberger V, Kollowa K, Obertacke U. Tourniquet application does not affect the periprosthetic bone cement penetration in total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2019 Jul;27(7):2071-2081. doi: 10.1007/s00167-018-5330-7. Epub 2018 Dec 11.

Reference Type BACKGROUND
PMID: 30539303 (View on PubMed)

Wang K, Ni S, Li Z, Zhong Q, Li R, Li H, Ke Y, Lin J. The effects of tourniquet use in total knee arthroplasty: a randomized, controlled trial. Knee Surg Sports Traumatol Arthrosc. 2017 Sep;25(9):2849-2857. doi: 10.1007/s00167-015-3964-2. Epub 2016 Jan 8.

Reference Type BACKGROUND
PMID: 26745962 (View on PubMed)

Other Identifiers

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Qilu200326

Identifier Type: -

Identifier Source: org_study_id

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