NCT03747198

Methylsulfonylmethane on Knee Laxity

Completed NA Last updated 1 June 2020

What this trial tests

NA trial testing methylsulfonylmethane in Ligament Injury in 32 participants. Completed in 1 October 2019.

Timeline

1 February 2019

Primary endpoint
1 October 2019

1 October 2019

Quick facts

Lead sponsor	University of California, Davis
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	supportive care
Enrollment	32
Start date	1 February 2019
Primary completion	1 October 2019
Estimated completion	1 October 2019
Sites	1 location across United States

Drugs / interventions tested

• methylsulfonylmethane
• Placebo

Conditions studied

• Ligament Injury — all drugs for Ligament Injury →
• Ligament; Laxity — all drugs for Ligament; Laxity →
• Tendon Rupture — all drugs for Tendon Rupture →
• Tendon Injuries — all drugs for Tendon Injuries →

Sponsor

University of California, Davis

Who can join

Adults 18 to 30, female only, with Ligament Injury or Ligament; Laxity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The proposed research will focus on determining the effect of methylsulfonylmethane (MSM) on knee laxity changes through the menstrual cycle in young active females.

As an extension to recent discovery, that MSM reverses the negative effect of estrogen on engineered ligament function, the proposed work is designed to determine whether MSM can decrease the negative effect of estrogen on knee laxity in females.

Ligament function is determined by the content and cross-linking of collagen, which is influenced by a milieu of biochemical and mechanical parameters. The greater the amount and cross-linking the greater the stiffness and strength of these connective tissues. In engineered ligaments it has been previously shown that the high levels of estrogen, normally present in the days before and after ovulation, can inhibit the cross-linking enzyme lysyl oxidase. This decrease in collagen cross-linking likely increases connective tissue laxity and contributes to observed 4-fold greater occurrence of anterior cruciate ligament (ACL) rupture in females. Conversely, MSM increases collagen cross-linking and recent work conducted by the Baar lab in engineered human ligaments treated with high estrogen demonstrated that MSM could completely reverse the effects of estrogen on ligament mechanics.

The proposed research aims to advance this promising pre-clinical data and apply in a clinical trial. This research also proposes to quantify that knee laxity increases up to 5mm between the first day of menstruation and the day after ovulation and also that the magnitude of the increase in laxity is directly related to the magnitude of the change in estrogen. Importantly, a direct relationship between knee laxity and ACL rupture exists. For every 1.3mm increase in anterior-posterior knee displacement, the odds of ACL rupture increase 4-fold. Therefore, any treatment that decreases knee laxity could be expected to reduce ACL ruptures and have widespread application across the general active population and high-level athletics.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.