Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

• ClinicalTrials.gov Identifier: NCT00549172
• Recruitment Status: Completed
• First Posted: October 25, 2007
• Results First Posted: March 23, 2015
• Last Update Posted: January 13, 2023
• Sponsor: Tampere University
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Operative (O)	Conservative (K)
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

Baseline Characteristics

Arm/Group Title		Operative (O)	Conservative (K)	Total
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
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

Outcome Measures

1. Primary Outcome

Title	The Lysholm Knee Score
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative (O)	Conservative (K)
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative (O)	Conservative (K)
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative (O)	Conservative (K)
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative (O)	Conservative (K)
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)
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Operative (O)	Conservative (K)
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
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

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Operative (O)		Conservative (K)
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	--/--		--/--
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
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Kalske J, Nurmi H, Kumm J, Sillanpaa N, Kiekara T, Turkiewicz A, Toivonen P, Englund M, Taimela S, Jarvinen TLN; FIDELITY (Finnish Degenerative Meniscus Lesion Study) Investigators. Arthroscopic partial meniscectomy for a degenerative meniscus tear: a 5 year follow-up of the placebo-surgery controlled FIDELITY (Finnish Degenerative Meniscus Lesion Study) trial. Br J Sports Med. 2020 Nov;54(22):1332-1339. doi: 10.1136/bjsports-2020-102813. Epub 2020 Aug 27.

Sihvonen R, Kalske R, Englund M, Turkiewicz A, Toivonen P, Taimela S, Jarvinen TLN; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Investigators. Statistical analysis plan for the 5-year and 10-year follow-up assessments of the FIDELITY trial. Trials. 2020 Jan 14;21(1):76. doi: 10.1186/s13063-019-3833-2.

Sihvonen R, Englund M, Turkiewicz A, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study Group. Mechanical Symptoms and Arthroscopic Partial Meniscectomy in Patients With Degenerative Meniscus Tear: A Secondary Analysis of a Randomized Trial. Ann Intern Med. 2016 Apr 5;164(7):449-55. doi: 10.7326/M15-0899. Epub 2016 Feb 9.

Sihvonen R, Paavola M, Malmivaara A, Itala A, Joukainen A, Nurmi H, Kalske J, Jarvinen TL; Finnish Degenerative Meniscal Lesion Study (FIDELITY) Group. Arthroscopic partial meniscectomy versus sham surgery for a degenerative meniscal tear. N Engl J Med. 2013 Dec 26;369(26):2515-24. doi: 10.1056/NEJMoa1305189.

Sihvonen R, Paavola M, Malmivaara A, Jarvinen TL. Finnish Degenerative Meniscal Lesion Study (FIDELITY): a protocol for a randomised, placebo surgery controlled trial on the efficacy of arthroscopic partial meniscectomy for patients with degenerative meniscus injury with a novel 'RCT within-a-cohort' study design. BMJ Open. 2013 Mar 9;3(3):e002510. doi: 10.1136/bmjopen-2012-002510.

• 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: January 13, 2023