Last reviewed · How we verify
NCT04413565
Infection Rate of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Controlled Study
NA trial testing Simultaneous bilateral total knee arthroplasty in Infection Joint in 413 participants. Status unknown.
30 November 2020
Quick facts
| Lead sponsor | Bezmialem Vakif University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 413 |
| Start date | 8 December 2016 |
| Primary completion | 30 November 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Turkey (Türkiye) |
Drugs / interventions tested
- Simultaneous bilateral total knee arthroplasty
- Sequenced bilateral TKA
Conditions studied
- Infection Joint — all drugs for Infection Joint →
- Joint Infection — all drugs for Joint Infection →
- Arthroplasty Complications — all drugs for Arthroplasty Complications →
Sponsor
Bezmialem Vakif University
Who can join
18 and older, any sex, with Infection Joint or Joint Infection. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The use of bilateral total knee replacements (TKR) is increasing with the number of patients with bilateral end-stage knee osteoarthritis. Bilateral TKR can be performed in three different ways: single-stage, two-team simultaneous bilateral TKR (two surgeons bilateral TKR); single-stage, a sequential bilateral TKR (single surgeon bilateral TKR); and two-stage bilateral TKR. Periprosthetic joint (PJI) infections are serious complications after TKR that negatively affect the aimed outcome, decrease patient satisfaction, and increase morbidity and mortality. The incidence of PJI is 1-2% and the number of cases is projected to grow as the indications for TKR continue to increase. Investigators will prospectively compare the incidence of periprosthetic joint infection between groups.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04413565
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Simultaneous bilateral total knee arthroplasty
Trials testing the same drug.
- NCT04434690 — Radiologic Results of One-Stage Bilateral TKR - One Surgeon Sequential vs. Two Surgeon Simultaneous: A Randomized Contro · NA · unknown
Other recruiting trials for Infection Joint
Currently open trials in the same condition.
- NCT03482245 — The Role of Circadian Clock Proteins in Innate and Adaptive Immunity · NA · recruiting
Other Bezmialem Vakif University trials
Trials by the same sponsor.
- NCT07369297 — PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY · not yet recruiting
- NCT07433595 — Association Between Child and Parental Stress and Bruxism in Children Aged 8-11 Years · not yet recruiting
- NCT07443111 — Comparison of Virtual Reality-Based and Routine Preoperative Education on Surgical Anxiety and Salivary Cortisol · NA · not yet recruiting
- NCT07421349 — Comparison of Pulmonary Functions and Respiratory Muscle Strength Between Children With Hearing Impairment and Healthy P · not yet recruiting
- NCT07414615 — Aerobic Training in Lower Extremity Lymphedema · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04413565 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bezmialem Vakif University
- Last refreshed: 4 June 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04413565.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing