MeniscectomyNCT01879852
Muscle Weakness and Post-traumatic Knee OA
A study testing Quadriceps intensive strengthening and Standard rehabilitation in people with Meniscectomy, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 35 years
- Conditions the study is for
- Meniscectomy
- What is being tested?
- Quadriceps intensive strengthening and Standard rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Aug 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
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.
- Conditions
- Meniscectomy
- Being tested
- Quadriceps intensive strengthening, Standard rehabilitation
- Keywords
- Quadriceps strength, Knee, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quadriceps intensive strengtheningBehavioural
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 rehabilitationBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation | Active comparator | Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises. Receives: 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. Receives: Behavioral: Quadriceps intensive strengthening; Behavioral: Standard rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (pre-surgery) to 1 year post-surgery
Secondary outcomes (2)
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]
Measured: 7 weeks post-surgery (post-intervention)
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.
Measured: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2013 (estimated)
- Study startOct 2008
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MeniscectomyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Terese Chmielewski, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879852
- Sponsor's protocol ID
- 00060374
- Other IDs
- K01HD052713
- Status last verified
- Sep 2014
- First submitted
- 13 Jun 2013
- Last updated
- 1 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Weakness and Post-traumatic Knee OA
- ClinicalTrials.gov ID
- NCT01879852
- Acronym / sponsor ID
- 00060374
- Conditions
- Meniscectomy
- Keywords
- Quadriceps strength, Knee, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Oct 2008
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Jun 2013 (estimated)
- Results
- Posted 11 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation | Active comparator | Behavioral: Standard rehabilitationStandard meniscectomy rehabilitation including knee range of motion and strengthening exercises. |
| Standard Rehabilitation + Quadriceps intensive strengthening | Experimental | Behavioral: Quadriceps intensive strengthening, Behavioral: Standard rehabilitationThe intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol. |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- bilateral injury
- concomitant ligamentous injury
- previous knee injury
- articular cartilage defect > Grade II on Outerbridge scale
- patellofemoral joint pain > 3/10 with activity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quadriceps intensive strengtheningQuadriceps 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. | Behavioural | Standard Rehabilitation + Quadriceps intensive strengthening |
| Standard rehabilitationStandard 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) | Behavioural | Standard Rehabilitation, Standard Rehabilitation + Quadriceps intensive strengthening |
Primary outcome
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.
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.
2 secondary outcomes
Single Leg Forward Hop Index
Time frame: 7 weeks post-surgery (post-intervention)
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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Meniscectomy
RecruitingObservational study
Assessment of the Degree of Regeneration After Partial Meniscectomy Based on Thin-layer MRI Image Segmentation and Reconstruction
Meniscus Regeneration, Partial Meniscectomy
Not yet recruiting
Needle Arthroscopy vs Conventional Arthroscopy in Knees
Meniscectomy, Meniscal Tears
Active, not recruiting
Autologous Bone Marrow Aspirate Concentrate in Patients Undergoing Meniscectomy
Osteoarthritis Post-meniscectomy
Not yet recruiting
Video-Based Education Versus In-Person Education in Patients Undergoing Arthroscopic Partial Meniscectomy
Partial Meniscectomy, Knee Arthroscopic Surgery
Not yet recruitingObservational study
Functionality of Lower Limbs in Patients Who Have Undergone Knee Meniscectomy
Meniscectomy Sequelae
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terese Chmielewski, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quadriceps intensive strengthening and Standard rehabilitation in people with Meniscectomy, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score (time frame: Baseline (pre-surgery) to 7 weeks post-surgery (post-intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2014; AzTrials last refreshed its copy on 27 Oct 2026.