We hypothesize that compared to traditional in-OR surgical intervention, in-office, needle arthroscopic meniscopexy will be preferred by patients, decrease time-to-recovery and be less costly.
ID
Bron
Verkorte titel
Aandoening
Peripheral tear in the red-red or red-white zones of the medial or lateral meniscus
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Hospital Anxiety and Depression Scale (HADS), pre-operatively, at discharge and at 1-day follow-up
Achtergrond van het onderzoek
The overall aim of this study is to evaluate the use of needle arthroscopy for in-office treatment of meniscal tears with meniscopexy under local anesthesia. This treatment entails repair of the tear with sutures and may include limited debridement if necessary. The primary study objective is to evaluate patient experience compared to traditional arthroscopic meniscopexy. As secondary objectives this study will compare meniscopexy using in-office needle arthroscopy and traditional in-OR conventional arthroscopy in terms of time-to-recovery, functional outcome and overall costs. We hypothesize that compared to in-OR surgical intervention, in-office treatment will be preferred by patients, decrease time-to-recovery and be less costly.
Doel van het onderzoek
We hypothesize that compared to traditional in-OR surgical intervention, in-office, needle arthroscopic meniscopexy will be preferred by patients, decrease time-to-recovery and be less costly.
Onderzoeksopzet
- Baseline
- Pre-op
- Discharge
- +1 day post-op
- +2 days post-op
- +7 days post-op
- +3 months post-op
Onderzoeksproduct en/of interventie
There are two intervention groups. In each group, an arthroscopic meniscopexy is performed. In
- Group 1, mensicopexy is performed with traditional arthroscopy, in the operating theatre, using general or regional anesthesia
- Group 2, meniscopexy is performed with needle arthroscopy, in the office procedure room, using local anesthesia
Algemeen / deelnemers
Wetenschappers
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Adult patients who are planned for meniscopexy on account of a peripheral tear in the red-red or red-white zones of the medial or lateral meniscus, and who provide informed consent for study participation.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Patients who were unable to mobilize independently prior to their meniscal injury
- Findings during diagnostic work-up in support of concomitant traumatic pathology that may hamper postoperative mobilization, as e.g. substantial damage to the cruciate ligaments
- Excessive difficulty in performing an in-office meniscopexyas expected by the treating surgeon
- Patients who do not agree to participate in the study's follow-up activities
- Recent (< 1 year) history of diabetes, myocardial infarction, congestive heart failure, stroke,
thromboembolic events, respiratory disease, opiate use, depression or anxiety disorder
- Adiposity grade I (BMI > 30 kg/m2)
- ASA ≥ 3
- Unable to provide informed consent
- A known history of coagulopathy
- Use of anticoagulation medication, other than a single thrombocyte aggregation inhibitor
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8860 |
| Ander register | METC AMC : W20_357 # 20.412 |