NCT01879852

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

October 1, 2014

Status Verified

September 1, 2014

Enrollment Period

4.8 years

First QC Date

June 13, 2013

Results QC Date

September 4, 2014

Last Update Submit

September 17, 2014

Conditions

Meniscectomy

Keywords

Quadriceps strengthKneeRehabilitation

Outcome Measures

Primary Outcomes (2)

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

    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.

    Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)

  • Change in Tibial Articular Cartilage Volume

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

    Baseline (pre-surgery) to 1 year post-surgery

Secondary Outcomes (2)

  • Single Leg Forward Hop Index

    7 weeks post-surgery (post-intervention)

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

    Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)

Study Arms (2)

Standard Rehabilitation

ACTIVE COMPARATOR

Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.

Behavioral: Standard rehabilitation

Standard Rehabilitation + Quadriceps intensive strengthening

EXPERIMENTAL

The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.

Behavioral: Quadriceps intensive strengtheningBehavioral: Standard rehabilitation

Interventions

Quadriceps intensive strengtheningBEHAVIORAL

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 + Quadriceps intensive strengthening
Standard rehabilitationBEHAVIORAL

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)

Standard RehabilitationStandard Rehabilitation + Quadriceps intensive strengthening

Eligibility Criteria

Age15 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF & Shands Orthopaedics and Sports Medicine Institute

Gainesville, Florida, 32607, United States

Location

Limitations and Caveats

Difficulty with subject recruitment due to concomitant injury with meniscal tear

Results Point of Contact

Title
Dr. Terese Chmielewski
Organization
University of Florida
tchm@ufl.edu
(352)273-6104

Study Officials

  • Terese Chmielewski, PT, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2013

First Posted

June 18, 2013

Study Start

October 1, 2008

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 1, 2014

Results First Posted

September 11, 2014

Record last verified: 2014-09

Locations

US(1)