The Benefit of Arthroscopic Partial Meniscectomy in Middle-Aged Patients

NCT01264991 | Terminated

• 1 other identifier: SJ-183
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Sham; Meniscus tear; Meniscectomy

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score - KOOS

  The primary outcome at 2 years follow-up will be a self-reported questionnaire, the Knee injury and Osteoarthritis Outcome Score (KOOS), comprising five different subscales: 1. pain 2. other symptoms 3. activities in daily living (ADL) 4. function in sport and recreation 5. knee-related quality of life (QOL) A mean of the 5 subscales will be calculated (KOOS5 = \[KOOSpain + KOOSsymptoms + KOOSADL + KOOSsport\&rec KOOSQOL\] / 5. Range 0 to 100, worst to best)

  2 year follow-up

Secondary Outcomes (6)

• One-leg jump test

  2 year follow-up

• Knee-bending test

  2 year follow-up

• Knee extension strength

  2 year follow-up

• EQ-5D

  2 year follow-up

• SF-36

  2 year follow-up

Study Arms (2)

APM group

EXPERIMENTAL

Procedure: Arthroscopic partial meniscectomy

Sham group

PLACEBO COMPARATOR

Procedure: Sham procedure

Interventions

Arthroscopic partial meniscectomy PROCEDURE

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

APM group

Sham procedure 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.

Sham group

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with knee pain for more than 2 months without significant trauma (only the index knee will be included)
• MRI-confirmed medial meniscus lesion (patients with a medial meniscus lesion AND a lateral lesion will also be included)
• Age 35-55 years\*
• Eligible for outpatient surgery - ASA score 1-2

You may not qualify if:

• Patients in need of acute surgery e.g. locking knees, high-energy trauma
• Symptoms associated with other musculoskeletal co-morbidities overriding the symptoms of the knee
• Grade 3 or 4 knee OA on the Kellgren-Lawrence classification
• Knee surgery within the last 2 years
• Obese patients with BMI \> 35
• Patients with ischemic heart disease
• Patients with diabetic late-complications
• Patients with thrombophilia
• Pregnancy
• Patients unable to speak Danish
• Patients with drug or alcohol abuse

Sponsors & Collaborators

• Slagelse Hospital: lead
• University of Southern Denmark: collaborator

Study Sites (2)

Næstved Hospital

Næstved, Region Sjælland, 4800, Denmark

Location

Slagelse Hospital

Slagelse, Region Sjælland, 4200, Denmark

Location

Related Publications (3)

• Roos EM, Hare KB, Nielsen SM, Christensen R, Lohmander LS. Better outcome from arthroscopic partial meniscectomy than skin incisions only? A sham-controlled randomised trial in patients aged 35-55 years with knee pain and an MRI-verified meniscal tear. BMJ Open. 2018 Feb 2;8(2):e019461. doi: 10.1136/bmjopen-2017-019461.

  PMID: 29420232 DERIVED

• Hare KB, Lohmander LS, Roos EM. The challenge of recruiting patients into a placebo-controlled surgical trial. Trials. 2014 May 13;15:167. doi: 10.1186/1745-6215-15-167.

  PMID: 24884948 DERIVED

• Hare KB, Lohmander LS, Christensen R, Roos EM. Arthroscopic partial meniscectomy in middle-aged patients with mild or no knee osteoarthritis: a protocol for a double-blind, randomized sham-controlled multi-centre trial. BMC Musculoskelet Disord. 2013 Feb 25;14:71. doi: 10.1186/1471-2474-14-71.

  PMID: 23442554 DERIVED

Study Officials

• Ewa Roos, Professor

  Research Unit of Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense

  STUDY CHAIR

• Kristoffer B Hare, MD

  Dept. of Orthopadeics, Slagelse Hospital, Region Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2010
• First Posted: December 22, 2010
• Study Start: February 21, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 24, 2017

Record last verified: 2017-10

Locations

DK (2)