Meniscectomy
Conditions
Keywords
Quadriceps strength, Knee, Rehabilitation
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.
Interventions
BEHAVIORALQuadriceps intensive strengthening
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.
BEHAVIORALStandard rehabilitation
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)
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. traumatic onset meniscal tear (i.e. specific mechanism of injury) 2. meniscectomy surgery performed within 12 months of index injury 3. meniscal tear confirmed at the time of surgery 4. subject anticipates living in close proximity to Gainesville for one year following surgery.
Exclusion criteria
1. bilateral injury 2. concomitant ligamentous injury 3. previous knee injury 4. articular cartilage defect \> Grade II on Outerbridge scale 5. patellofemoral joint pain \> 3/10 with activity 6. lower limb alignment \> 5 degrees of valgus or varus 7. contraindication to an MR examination including: a pacemaker, metal implants which are not MR compatible, pregnancy and severe claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | 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. |
| Change in Tibial Articular Cartilage Volume | 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
| Measure | Time frame | Description |
|---|---|---|
| Single Leg Forward Hop Index | 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 \[(distance on the surgical side/distance on the non-surgical side) \*100\] |
| 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
29 subjects were consented to the study. During pre-surgery (baseline) testing, 2 subjects were found not to have a meniscal tear (inclusion criterion) and were withdrawn from the study. Total number of subjects meeting eligibility criteria was 27.
Participants by arm
| Arm | Count |
|---|---|
| Standard Rehabilitation Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.
Standard rehabilitation: 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) | 14 |
| Standard Rehabilitation + Quadriceps Intensive Strengthening The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.
Quadriceps intensive strengthening: 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: 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) | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Standard Rehabilitation + Quadriceps Intensive Strengthening | Total | Standard Rehabilitation |
|---|---|---|---|
| Age, Continuous | 18.3 years STANDARD_DEVIATION 2.8 | 20.4 years STANDARD_DEVIATION 4 | 22.5 years STANDARD_DEVIATION 5.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 4 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants | 23 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 180.1 cm STANDARD_DEVIATION 8.8 | 178.5 cm STANDARD_DEVIATION 8.7 | 176.9 cm STANDARD_DEVIATION 8.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 21 Participants | 12 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 2 Participants |
| Sex: Female, Male Male | 12 Participants | 24 Participants | 12 Participants |
| Weight | 100.9 kg STANDARD_DEVIATION 30.1 | 89.8 kg STANDARD_DEVIATION 26.7 | 78.7 kg STANDARD_DEVIATION 13.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 14 | 0 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
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.
Time frame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Rehabilitation | Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | 22.2 units on a scale | Standard Deviation 21.6 |
| Standard Rehabilitation + Quadriceps Intensive Strengthening | Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score | 20.6 units on a scale | Standard Deviation 21.1 |
Primary
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.
Time frame: Baseline (pre-surgery) to 1 year post-surgery
Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. Images were not analyzable for one subject in the Standard+Quadriceps Intensive Strengthening group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Rehabilitation | Change in Tibial Articular Cartilage Volume | 0.18 percentage change from baseline | Standard Deviation 3.21 |
| Standard Rehabilitation + Quadriceps Intensive Strengthening | Change in Tibial Articular Cartilage Volume | -1.24 percentage change from baseline | Standard Deviation 4.27 |
Secondary
Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II)
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.
Time frame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Rehabilitation | Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | 0.01 log (ng/mmol) | Standard Deviation 0.18 |
| Standard Rehabilitation + Quadriceps Intensive Strengthening | Change in Urinary Concentrations of C-terminal Crosslinking Telopeptide of Type II Collagen (CTX-II) | -0.11 log (ng/mmol) | Standard Deviation 0.13 |
Secondary
Single Leg Forward Hop Index
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 \[(distance on the surgical side/distance on the non-surgical side) \*100\]
Time frame: 7 weeks post-surgery (post-intervention)
Population: 2 subjects in the Standard Rehabilitation group did not complete the intervention or post-treatment testing. 2 subjects in the Standard Rehabilitation group and 1 subject in the Standard + Quadriceps Intensive Strengthening group did not complete hop testing.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Rehabilitation | Single Leg Forward Hop Index | 87.1 percentage | Standard Deviation 15.2 |
| Standard Rehabilitation + Quadriceps Intensive Strengthening | Single Leg Forward Hop Index | 90.1 percentage | Standard Deviation 10.9 |