Knee InjuriesNCT05073263
Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
A study testing Physical Therapy in people with Knee Injuries, run by Twin Cities Orthopedics at 1 site in United States.
Trial summary
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery. Read more about this study
- Who is it for?
- Ages 14 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Injuries
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 14 to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- ≥ 14 years old, <60
- Reconstruction of FCL alone
- Combined FCL + ACL reconstructions
- Males or females
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Who cannot join
- < 14 years old, > 60
- Pregnant
- Revision FCL reconstructions
- Concurrent biceps femoris or lateral capsular repairs
- Concurrent PCL or MCL reconstructions
- Concomitant meniscus root or radial repair surgery with transtibial technique
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Twin Cities Orthopedics
Edina, Minnesota, 55435
Becky Stone, 952-456-7136, research@tcomn.com
Robert F LaPrade, MD, PhD
About this study
Official title: Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: A Randomized Controlled Trial
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.
Read the detailed description
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- partial weightbearing
- full controlled weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.
Specific Aims
- Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.
- Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.
The Investigators hypothesize that there will be no clinically significant difference (< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.
The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.
- Conditions
- Knee Injuries
- Being tested
- Physical Therapy
- Keywords
- fibular collateral ligament (FCL), anterior cruciate ligament (ACL)
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
Patient is randomized to the weightbearing group the day after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Partial weight -bearing for the first six weeks after surgery | Active comparator | Partial weightbearing will be defined as 40% of the patient's body weight. Receives: Other: Physical Therapy |
| Full weight -bearing for the first six weeks after surgery | Experimental | If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gapping (mm) measured on Standard of Care Varus stress radiographs
stress radiograph
Measured: Pre-operative
Gapping (mm) measured Standard of Care Varus stress radiographs
stress radiograph
Measured: 6 months post-surgery
Secondary outcomes (5)
Numeric Pain Scale (NPS) (0-10 rating)
Pain scale 0-100
Measured: Baseline and 6 months
Measurements by physical therapists (Edema, thigh circumference)
Measurements with tape
Measured: 4,7, and 10 months after surgery
Measurements by physical therapists (Range of Motion)
Measurements with goniometer
Measured: 4,7, and 10 months after surgery
Measurements by physical therapists (Quadriceps strength, gait analysis)
Measurements by biomechanics lab
Measured: 4,7, and 10 months after surgery
Patient reported outcome scores
Surveys: International Knee Documentation Committee (IKDC), Cincinnati Knee Rating System (Cincinnati), Knee injury and Osteoarthritis Outcome Score (KOOS), Tegner, Lysholm Knee Scoring Scale (Lysholm), and Veterans Rand 12 (VR-12) or Short Form-12 (SF-12) General Health Survey, lower extremity functional scale, Sports Medicine Questionnaire and survey/patient satisfaction
Measured: Baseline, 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start1 Jan 2020
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InjuriesStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Twin Cities Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert F LaPrade, MD, PhD, Principal investigator, Twin Cities Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073263
- Sponsor's protocol ID
- RFL_FWB vs PWB-FCL
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2021
- Last updated
- 6 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full Weightbearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Reconstruction of the Fibular Collateral Ligament: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05073263
- Acronym / sponsor ID
- RFL_FWB vs PWB-FCL
- Conditions
- Knee Injuries
- Keywords
- fibular collateral ligament (FCL), anterior cruciate ligament (ACL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Twin Cities OrthopedicsUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Oct 2021 (actual)
- Results
- Not posted in the source record
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 prospective randomized controlled trial with the purpose to determine if patients undergoing fibular collateral ligament (FCL) reconstruction alone or combined FCL and anterior cruciate ligament (ACL) reconstructions can safely begin full controlled weightbearing for the first six weeks after surgery.
Detailed description
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
- partial weightbearing
- full controlled weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 13 and a CTi ligament knee brace (Össur Americas, Foothill Ranch, California) will be used from 14 to 42 days post-surgery to protect against side-to-side motion while weight bearing.
Specific Aims
- Primary Aim: To determine if there is a difference in millimeters of varus gapping on anteroposterior (AP) stress radiographs at six months post-surgery between patients who are partial weight bearing versus full controlled weight bearing during the first six weeks of post-surgical rehabilitation. This distance will be compared to varus gapping measured on the contralateral uninjured control knee.
- Secondary Aim: To determine if there is a difference in pain, edema, and range of motion, gait, quadriceps strength, and patient reported outcomes between groups.
The Investigators hypothesize that there will be no clinically significant difference (< 2 mm change) in varus gapping between the control and treatment groups. Results of this study will help to expedite return to pre-injury levels of activity and decrease adverse sequelae associated with non-weight bearing such as osteopenia, muscle atrophy, loss of ankle range of motion, and increased risk of deep vein thrombosis.
The current standard of care for FCL reconstruction is early controlled partial weight -bearing for the first six weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Partial weight -bearing for the first six weeks after surgery | Active comparator | Other: Physical TherapyPartial weightbearing will be defined as 40% of the patient's body weight. |
| Full weight -bearing for the first six weeks after surgery | Experimental | Other: Physical TherapyIf the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. |
Who may qualify
- Ages
- 14 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- ≥ 14 years old, <60
- Reconstruction of FCL alone
- Combined FCL + ACL reconstructions
- Males or females
- Is willing and able to comply with the clinical trial plan and able to understand and sign the Patient Informed Consent Form.
Key exclusion criteria (6 listed)
- < 14 years old, > 60
- Pregnant
- Revision FCL reconstructions
- Concurrent biceps femoris or lateral capsular repairs
- Concurrent PCL or MCL reconstructions
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 |
|---|---|---|
| Physical TherapyPatient is randomized to the weightbearing group the day after surgery. | Other | Full weight -bearing for the first six weeks after surgery, Partial weight -bearing for the first six weeks after surgery |
Primary outcome
Gapping (mm) measured on Standard of Care Varus stress radiographs
Time frame: Pre-operative
stress radiograph
Gapping (mm) measured Standard of Care Varus stress radiographs
Time frame: 6 months post-surgery
stress radiograph
5 secondary outcomes
Numeric Pain Scale (NPS) (0-10 rating)
Time frame: Baseline and 6 months
Measurements by physical therapists (Edema, thigh circumference)
Time frame: 4,7, and 10 months after surgery
Measurements by physical therapists (Range of Motion)
Time frame: 4,7, and 10 months after surgery
Measurements by physical therapists (Quadriceps strength, gait analysis)
Time frame: 4,7, and 10 months after surgery
Patient reported outcome scores
Time frame: Baseline, 3 months, 6 months, 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Injuries
RecruitingPhase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
Osteoarthritis, Knee, Post-traumatic Osteoarthritis
Recruiting
Sterile Allogeneic Spongioflex® Allograft as Partial Meniscal Replacement After Incomplete Meniscal Loss
Meniscus Lesion
Active, not recruitingObservational study
Impact of Chronic Venous Insufficiency on Outcomes After Total Knee Arthroplasty
Total Knee Anthroplasty, Venous Insufficiency (Chronic)(Peripheral)
RecruitingObservational study
Knee Cartilage Repair Registry
Knee Injuries, Joint Surface Knee Lesions
Not yet recruitingObservational study
Post Market Clinical Follow-up of LARS® Ligaments Associated to Fixations in Acute or Chronic Injury of the Anterior Cruciate Ligament (ACL), Posterior Cruciate (PCL) or Medial Collateral (MCL) Ligaments of the Knee
Knee Ligament Injury
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.
Robert F LaPrade, MD, PhD principal investigator
Twin Cities Orthopedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Knee Injuries, run by Twin Cities Orthopedics 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Becky Stone (952-456-7136, research@tcomn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gapping (mm) measured on Standard of Care Varus stress radiographs (time frame: Pre-operative). 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 6 Oct 2026; AzTrials last refreshed its copy on 29 Oct 2026.