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Completed

NCT Number: NCT01879852

Muscle Weakness and Post-traumatic Knee OA

This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of standard or quadriceps intensive rehabilitation. The objective of the study was to determine the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.

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Key information

Conditions

Meniscectomy

Age range

15 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • traumatic onset meniscal tear (i.e. specific mechanism of injury)
  • meniscectomy surgery performed within 12 months of index injury
  • meniscal tear confirmed at the time of surgery
  • subject anticipates living in close proximity to Gainesville for one year following surgery.

Exclusion criteria

  • bilateral injury
  • concomitant ligamentous injury
  • previous knee injury
  • articular cartilage defect > Grade II on Outerbridge scale
  • patellofemoral joint pain > 3/10 with activity
  • lower limb alignment > 5 degrees of valgus or varus
  • contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.

Treatment and study plan

Quadriceps intensive strengthening

Behavioral

Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.

standard rehabilitation

Behavioral

Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)

Primary outcomes

  1. Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score

    Time frame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)

    The IKDC is a measure of self-reported knee function and includes items related to symptoms and functional activity. Responses on the IKDC subjective knee form will be recorded on hard-copy and the summary score computed. The highest (best) possible score is 100 points and the lowest (worst) possible score is 0 points.

  2. Change in Tibial Articular Cartilage Volume

    Time frame: Baseline (pre-surgery) to 1 year post-surgery

    A magnetic resonance image (MRI) of the knee will be acquired and software will be used to quantify tibial articular cartilage volume.

Secondary outcomes

  1. Single Leg Forward Hop Index

    Time frame: 7 weeks post-surgery (post-intervention)

    Three trials of the single leg forward hop will be collected on each side. Distance will be averaged across trials. The single leg hop index will be computed as [(distance on the surgical side/distance on the non-surgical side) *100]

  2. Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)

    Time frame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)

    CTX-II is a biomarker of Type II collagen degradation. Early-morning, second void, fasting urine samples will be collected and stored. Concentrations of CTX-II will be determined with enzyme-linked immunosorbent assay, corrected for creatine concentration, and log-transformed. Creatinine concentration will also be determined with enzyme-linked immunosorbent assay.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Jun 18, 2013
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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