Bilateral Simultaneous Total Knee Arthroplasty for Bilateral Gonarthrosis

NCT ID: NCT04299516

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 246 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-08
• Study Completion Date: 2019-12-31

Brief Summary

The effects of two-team and single-team simultaneous bilateral total knee arthroplasty (SBA) on peri- and postoperative complications are not clear. The investigators hypothesized that two-team SBA has lower early postoperative complication rates than single-surgeon SBA. Therefore, this prospective study compared minor and major complications for 90 days postoperatively between two-surgeon and single-surgeon SBA.

Detailed Description

Study Design:

This prospective randomized study was approved by our institution's Clinical Research Ethics Committee (08.11.2017-71306642-050.01.04). The protocol conforms to CONSORT guidelines for parallel-group randomized trials and the protocol is designed to conform to the principles of the Declaration of Helsinki.

Participant :

The investigators will enroll 246 patients with primary bilateral symptomatic knee osteoarthritis that was refractory to conservative treatment who underwent bilateral TKA (total knee arthroplasty) under single anaesthesia between 2017 and 2018. An informed consent form will be obtained from all patients.

The schedule for randomization was randomly generated using a computer before the initiation of the trial. Patients were randomly assigned in a 1:1 ratio. A blind medical staff member will organize the days of the surgeries of randomized patients for the two-surgeon (TS) or single-surgeon (SS) groups. Neither patients nor assessors will know about randomization results. The outcome assessor will be blinded to group allocation and will no involve in providing the interventions. The statistician performing the statistical analyses will be blinded to group allocation.

Surgical procedures:

All surgeries will be performed by two high-volume surgeons under regional or general anaesthesia. Both surgeons always will operate on the same side. Each of patients will receive a total knee prostheses-Vanguard (Zimmer Biomet,Inc, Warsaw, IN) - using a standard medial parapatellar approach without the use of a tourniquet. All patients will be given 2 g cefazolin for infection prophylaxis and 1 g tranexamic acid for blood loss prophylaxis intravenously 30 min before the incision. In the TS group, the two surgeons will start the incisions at the same time using two different instrumentation sets and with their own scrub nurses. In the SS group, the surgeon will operate on both knees consecutively. No Hemovac drains will be used in either group. After closing the joint capsule, 1 g tranexamic acid will be injected into the joint in both groups.

All patients will start a standard physiotherapy program with the same blinded therapist. All patients will be started walking on the first postoperative day, using two crutches or a walker. Antibiotic prophylaxis will be continued for 24 h with 1 g intravenous cefazolin every 6 h. Venous thromboembolism prophylaxis will be administered using low-molecular-weight heparin for 4 weeks postoperatively. The investigators will check the estimated blood loss (EBL) on the first postoperative day. All patients will be asked to visit our outpatient clinic at 2 and 6 weeks and 3 months postoperatively. For functional outcomes and pain will be used the Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and a visual analog scale (VAS) preoperatively and 90 days postoperatively.

Primary Outcome:

The prespecified primary outcome was the between-group difference according to the rate of major complications.The investigators will assess major complications in all patients until 90 days postoperatively.

Secondary Outcomes:

The investigators also will assess the estimated blood loss (EBL), minor complications, operation time and functional results among the groups. The EBL will be calculated using the Gross formula and compared between the groups.

Statistical methods:

Categorical variables will be analyzed using the chi-square test and continuous variables will be tested using the Mann-Whitney U-test. The statistical analyses will be performed using IBM SPSS Statistics for Windows, ver. 22.0. (IBM, Armonk, NY). Significance was set at α < 0.05.

Conditions

Bilateral Total Knee Arthroplasty; Gonarthrosis; Primary, Bilateral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Two-team SBA

Two-team simultaneous bilateral total knee arthroplasty

Group Type: EXPERIMENTAL

Two-team simultaneous bilateral total knee arthroplasty

Intervention Type: PROCEDURE

Bilateral total knee arthroplasty can be performed in three different ways: single-stage, two-team simultaneous bilateral total knee arthroplasty; single-stage, one-surgeon, and two-stage bilateral total knee arthroplasty. Two surgeons will operate simultaneously on one side for two-team SBA.

Single-team SBA

Single-team simultaneous bilateral total knee arthroplasty

Group Type: ACTIVE_COMPARATOR

Single-team simultaneous bilateral total knee arthroplasty

Intervention Type: PROCEDURE

One surgeon will operate sequentially on both sides for one-surgeon SBA

Interventions

Two-team simultaneous bilateral total knee arthroplasty

Bilateral total knee arthroplasty can be performed in three different ways: single-stage, two-team simultaneous bilateral total knee arthroplasty; single-stage, one-surgeon, and two-stage bilateral total knee arthroplasty. Two surgeons will operate simultaneously on one side for two-team SBA.

Intervention Type: PROCEDURE

Single-team simultaneous bilateral total knee arthroplasty

One surgeon will operate sequentially on both sides for one-surgeon SBA

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Primary bilateral knee osteoarthritis with refractory to conservative treatment
• Patients who accept participation in the research and the randomization

Exclusion Criteria

• no history of malignancy
• less than 75 years old
• without severe extra-articular deformities
• severe cardiac insufficiency and morbid obesity
• without systemic inflammatory diseases

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bezmialem Vakif University

OTHER

Sponsor Role: lead

Responsible Party

Gökçer Uzer

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Bezmialem Vakif University

Istanbul, Fatih, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Uzer G, Aliyev O, Yildiz F, Gungoren N, Elmali N, Tuncay I. Safety of one-stage bilateral total knee arthroplasty -one surgeon sequential vs. two surgeons simultaneous: a randomized controlled study. Int Orthop. 2020 Oct;44(10):2009-2015. doi: 10.1007/s00264-020-04704-9. Epub 2020 Jul 10.

Reference Type: DERIVED

PMID: 32651711 (View on PubMed)

Other Identifiers

08.11.2017-71306642-050.01.04

Identifier Type: -

Identifier Source: org_study_id