No registrations found.
ID
Source
Brief title
Health condition
Peripheral tear in the red-red or red-white zones of the medial or lateral meniscus
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hospital Anxiety and Depression Scale (HADS), pre-operatively, at discharge and at 1-day follow-up
Secondary outcome
General
- Serious adverse events (results in death, is life-threatening at the time of the event, requires
hospitalization, results in persistent disability or incapacity)
- Adverse events (infection, bleeding requiring re-operation, neurological damage present at 3-month followup)
- Failure of the needle arthroscopic procedure due to e.g. need for general or regional anesthesia (e.g. due to an intolerable procedure under local anesthesia), device failure, inability to perform an adequate meniscopexy, inaccessibility of the joint
- Procedure time
- Hospital length of stay
Functional outcome
- Range of motion of the joint
- Presence of residual complaints requiring additional surgery (yes/no)
Patient reported outcome
- Hospital Anxiety and Depression Scale (HADS)
- NRS of pain, measured a. at rest and b. after mobilization
- Ability to walk normally
- Ability to perform professional work
- KOOS
- EQ5D
- NRS of satisfaction
- Net Promoter Score (NPS)
- Use of opioids
- Use of home care support
Costs
Background summary
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.
Study objective
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.
Study design
- Baseline
- Pre-op
- Discharge
- +1 day post-op
- +2 days post-op
- +7 days post-op
- +3 months post-op
Intervention
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
Inclusion criteria
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.
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8860 |
| Other | METC AMC : W20_357 # 20.412 |