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Needle arthroscopic meniscopexy

Patient experience, outcome and costs of in-office needle arthroscopic meniscopexy compared to traditional arthroscopic meniscopexy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20688
Enrollment
22
Registered
2020-08-26
Start date
2020-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral tear in the red-red or red-white zones of the medial or lateral meniscus

Interventions

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

Sponsors

Amsterdam UMC
Lead Sponsor

Eligibility

Inclusion criteria

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

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 ( 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 outcomes

Primary

MeasureTime frame
Hospital Anxiety and Depression Scale (HADS), pre-operatively, at discharge and at 1-day follow-up

Secondary

MeasureTime frame
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

Contacts

Public ContactTobias Stornebrink

Amsterdam UMC

t.stornebrink@amsterdamumc.nl+31205666540

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)