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Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00549172
Recruitment Status : Completed
First Posted : October 25, 2007
Results First Posted : March 23, 2015
Last Update Posted : June 29, 2018
Sponsor:
Collaborators:
Helsinki University Central Hospital
Kuopio University Hospital
Turku University Hospital
Central Finland Hospital District
Information provided by (Responsible Party):
Raine Sihvonen, Tampere University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Interventions Procedure: Operative (partial arthroscopy)
Procedure: Conservative (diagnostic arthroscopy)
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Period Title: Overall Study
Started 70 76
Completed 70 76
Not Completed 0 0
Arm/Group Title Operative (O) Conservative (K) Total
Hide Arm/Group Description

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Total of all reporting groups
Overall Number of Baseline Participants 70 76 146
Hide Baseline Analysis Population Description
Age, Sex, Weight, Height, BMI, Duration of medial knee pain, Type of onset of symptoms, Radiographic assessment (Kellfren-Lawrence), Clinical meniscal tests
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 70 participants 76 participants 146 participants
52  (7) 52  (7) 52  (7)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 76 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
70
 100.0%
76
 100.0%
146
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 70 participants 76 participants 146 participants
Female
28
  40.0%
29
  38.2%
57
  39.0%
Male
42
  60.0%
47
  61.8%
89
  61.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Finland Number Analyzed 70 participants 76 participants 146 participants
70 76 146
1.Primary Outcome
Title The Lysholm Knee Score
Hide Description The Lysholm knee score is based on an eight-item questionnaire designed to evaluate knee function and symptoms in activities of daily living. Scores range from 0 to 100; higher scores indicate less severe symptoms.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description:

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Overall Number of Participants Analyzed 70 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
82.2
(78.4 to 85.9)
83.4
(80.3 to 86.5)
2.Primary Outcome
Title Pain After Exercise (VAS)
Hide Description Knee pain after exercise (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description:

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Overall Number of Participants Analyzed 70 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
2.7
(2.1 to 3.3)
2.9
(2.3 to 3.4)
3.Primary Outcome
Title WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)
Hide Description The Western Ontario Meniscal Evaluation Tool (WOMET) contains 16 items addressing three domains: 9 items addressing physical symptoms; 4 items addressing disabilities with regard to sports, recreation, work, and lifestyle; and 3 items addressing emotions. The score indicates the percentage of a normal score; therefore, 100 is the best possible score, and 0 is the worst possible score.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description:

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Overall Number of Participants Analyzed 70 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
81.0
(76.1 to 85.9)
79.9
(75.1 to 84.7)
4.Secondary Outcome
Title 15-D (General Quality of Life -Assessment Tool)
Hide Description The 15D instrument is a generic health-related quality-of-life instrument comprising 15 dimensions. The maximum 15D score is 1 (full health), and the minimum score is 0 (death).
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description:

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Overall Number of Participants Analyzed 70 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
0.94
(0.92 to 0.95)
0.92
(0.90 to 0.93)
5.Secondary Outcome
Title Pain at Rest (VAS)
Hide Description Knee pain at rest (during the preceding week) was assessed on a rating scale of 0 to 10, with 0 denoting no pain and 10 denoting extreme pain.
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description:

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

n=70

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

n=76

Overall Number of Participants Analyzed 70 76
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.6
(1.0 to 2.1)
1.9
(1.4 to 2.5)
6.Secondary Outcome
Title Cost Effectiveness
Hide Description Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.
Time Frame 1 and 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Operative (O) Conservative (K)
Hide Arm/Group Description

Partial resection of degenerative tear of medial meniscus

Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus

Arthroscopy (diagnostic)

Conservative (diagnostic arthroscopy): Diagnostic arthroscopy

All-Cause Mortality
Operative (O) Conservative (K)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Operative (O) Conservative (K)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/70 (1.43%)      0/76 (0.00%)    
Infections and infestations     
Serious adverse event [1]  1/70 (1.43%)  1 0/76 (0.00%)  0
[1]
A deep infection of the index knee 4 months after surgery
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Operative (O) Conservative (K)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/70 (0.00%)      0/76 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Teppo Järvinen, Head of study chair
Organization: University of Helsinki
EMail: teppo.jarvinen@helsinki.fi
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Raine Sihvonen, Tampere University
ClinicalTrials.gov Identifier: NCT00549172    
Other Study ID Numbers: R06157
First Submitted: October 24, 2007
First Posted: October 25, 2007
Results First Submitted: March 16, 2015
Results First Posted: March 23, 2015
Last Update Posted: June 29, 2018