The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients

Summary

BACKGROUND Osteoarthritis (OA) is the most common form of arthritis and the knee is one of the most affected joints. The meniscus plays an important role in the development of knee OA. It is unclear whether a degenerative meniscus tear is a risk factor in developing knee OA or a sign of the disease. The standard treatment for a degenerative meniscus tear is an arthroscopic partial meniscectomy (APM). There is strong evidence that this puts the knee at high risk of later developing OA. Earlier studies have shown a significant placebo effect from surgical procedures, in general, and an arthroscopic knee procedure, in particular.

PURPOSE The overall purpose of this study is to gather information that might lead to a reduction in the development of OA in middle-aged patients. The investigators hypothesise that the benefit from an arthroscopic partial meniscectomy is due to the placebo effect measured on self-reported outcomes, and that the meniscectomy contributes to the development of knee OA as seen on radiography.

METHODS The investigators will include 100 patients aged from 35 to 55 years with an MRI-confirmed medial meniscus tear and without knee OA (excluding patients with Grade 3 or 4 knee OA on the Kellgren-Lawrence classification). Participants will be randomised to either a standard APM procedure or a sham procedure and both groups will receive standard post-operative care. The primary outcomes will be a self-reported questionnaire, the KOOS score, and a functionality test after 3 and 24 months.

Conditions

• Degenerative Meniscus Tear

Interventions

PROCEDURE

Arthroscopic partial meniscectomy

The arthroscopic partial meniscectomy will be performed on an outpatient basis by experienced surgeons at a level of at least attending physicians or at the last year of residency. All arthroscopies will be performed in general anaesthesia combined with local anaesthesia. After general anaesthesia is induced, the knee will be examined for stability. Thereafter two standard portals on the lateral and medial side of the ligamentum patella will be created but no outflow cannula inserted. An arthroscope will be used with a pressure-controlled irrigation system. Tourniquet use will be according to surgeon preference. The strategy for the meniscectomy will be to preserve as much tissue as possible. A standard operation protocol will be used to document possible findings in cartilage, ligaments, synovium and the medial and lateral meniscus. Meniscus lesions and type of will be registered and changes in the articular cartilage will be classified according to the ICRS classification

PROCEDURE

Sham procedure

The placebo procedure will be performed under the same conditions as above. The patient will be fully sedated in general anaesthesia. As above, the stability of the knee will be examined. Local anaesthetic will be applied as above and 2 skin incisions will be made at the same location and the same size as above. Then the knee will be manipulated as if a real arthroscopy were being done, the spillage of water and all the other equipment needed for an arthroscopy will be used and manipulated. No instruments will enter the portals for arthroscopy to avoid the possibility of osteochondral lesions and unwanted interventions by the surgeon.

Sponsors & Collaborators

• University of Southern Denmark

  collaborator OTHER

• Slagelse Hospital

  lead OTHER

Principal Investigators

• Ewa Roos, Professor · Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense

• Kristoffer B Hare, MD · Dept. of Orthopadeics, Slagelse Hospital, Region Zealand

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-02-21

Primary Completion

2015-11-30

Completion

2015-11-30

Countries

• Denmark

Study Locations