NCT04313569

Brief Summary

The study is prospective comparative study, conducted in Erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. All were clinically diagnosed to have degenerative medial meniscal tear then confirmed by MRI. Thirty patients were treated conservatively, thirty patients were treated arthroscopically.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 16, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 16, 2020

Last Update Submit

March 18, 2020

Conditions

Keywords

Degenerative meniscal teararthroscopic partial meniscectomyconservative treatmentmedial meniscal tear

Outcome Measures

Primary Outcomes (2)

  • Lysholm Knee Scoring Scale

    Lysholm Knee score scale has (8) parts (swelling, pain, squatting, support, stair climbing, limping, locking and instability). Score of 100 means no problems in knee.

    All patients were reviewed and evaluated one year, by Lysholm score

  • Visual analogue score

    Ten points Visual Analogue Score scale used in order to meassure the severity of knee pain during the study. Zero meaning no pain while 10 meaning the most severe pain

    All patients were reviewed and evaluated one year, by Visual Analogue score scales

Study Arms (2)

Conservative treatment

NO INTERVENTION

Use of medications, like analgesic, muscle relaxants, non-steroidal anti-inflammatory drugs (NSAID) and local painkillers, depending on the patient condition, and physiotherapy, lifestyle and daily activity modification, patient education about positioning of the knee

Arthroscopic menisctomy

OTHER
Procedure: Arthroscopic menisctomy

Interventions

Arthroscopic medial menisctomy

Arthroscopic menisctomy

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician.
  • Grade 3 degenerative tear of medial meniscus approved on MRI.

You may not qualify if:

  • Meniscal tear due to trauma.
  • Any rheumatologic knee disease.
  • MRI showing ligament injury, loose bodies, tumors and osteochondral defects.
  • Former surgery of knee and lower limb fractures in the last year.
  • Knee joints with osteoarthritis graded 2 or more according to Kellgren-Lawrence scale (Kellgren and Lawrence, 1957) on weight-bearing knee x-ray.
  • Lateral meniscus tear.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sherwan Hamawandi

Erbil, 44001, Iraq

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Arthroscopic meniscectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of orthopedic surgery

Study Record Dates

First Submitted

March 16, 2020

First Posted

March 18, 2020

Study Start

August 1, 2017

Primary Completion

September 1, 2019

Study Completion

September 30, 2019

Last Updated

March 20, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations