Trial Outcomes & Findings for Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear (NCT NCT00549172)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

146 participants

Primary outcome timeframe

One year

Results posted on

2023-01-13

Participant Flow

Participant milestones

Participant milestones
Measure	Operative (O) Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
Overall Study STARTED	70	76
Overall Study COMPLETED	70	76
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Arthroscopy in the Treatment of Degenerative Medial Meniscus Tear

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76	Total n=146 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 7 • n=93 Participants	52 years STANDARD_DEVIATION 7 • n=4 Participants	52 years STANDARD_DEVIATION 7 • n=27 Participants
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	70 Participants n=93 Participants	76 Participants n=4 Participants	146 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	28 Participants n=93 Participants	29 Participants n=4 Participants	57 Participants n=27 Participants
Sex: Female, Male Male	42 Participants n=93 Participants	47 Participants n=4 Participants	89 Participants n=27 Participants
Region of Enrollment Finland	70 participants n=93 Participants	76 participants n=4 Participants	146 participants n=27 Participants

PRIMARY outcome

Timeframe: One year

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.

Outcome measures

Outcome measures
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
The Lysholm Knee Score	82.2 units on a scale Interval 78.4 to 85.9	83.4 units on a scale Interval 80.3 to 86.5

PRIMARY outcome

Timeframe: One year

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.

Outcome measures

Outcome measures
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
Pain After Exercise (VAS)	2.7 units on a scale Interval 2.1 to 3.3	2.9 units on a scale Interval 2.3 to 3.4

PRIMARY outcome

Timeframe: One year

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.

Outcome measures

Outcome measures
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
WOMET (Western Ontario Meniscal Tear -Disease Specific Quality of Life -Assessment Tool)	81.0 units on a scale Interval 76.1 to 85.9	79.9 units on a scale Interval 75.1 to 84.7

SECONDARY outcome

Timeframe: One year

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).

Outcome measures

Outcome measures
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
15-D (General Quality of Life -Assessment Tool)	0.94 units on a scale Interval 0.92 to 0.95	0.92 units on a scale Interval 0.9 to 0.93

SECONDARY outcome

Timeframe: One year

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.

Outcome measures

Outcome measures
Measure	Operative (O) n=70 Participants Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus n=70	Conservative (K) n=76 Participants Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy n=76
Pain at Rest (VAS)	1.6 units on a scale Interval 1.0 to 2.1	1.9 units on a scale Interval 1.4 to 2.5

SECONDARY outcome

Timeframe: 1 and 2 years

Cost effectiveness data comparing arthroscopic partial meniscectomy and diagnostic arthroscopy. Costs are based on healthcare utilisation and sickness absence.

Outcome measures

Outcome data not reported

Adverse Events

Operative (O)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Conservative (K)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Operative (O) n=70 participants at risk Partial resection of degenerative tear of medial meniscus Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus	Conservative (K) n=76 participants at risk Arthroscopy (diagnostic) Conservative (diagnostic arthroscopy): Diagnostic arthroscopy
Infections and infestations Serious adverse event	1.4% 1/70 • Number of events 1	0.00% 0/76

Other adverse events

Adverse event data not reported

Additional Information

Dr. Teppo Järvinen, Head of study chair

University of Helsinki

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place