Knee InjuriesNCT05073276
Non- vs Partial Controlled Weightbearing After Multiple Knee 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 isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL)… 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 Jan 2028
- 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 PCL alone
- Reconstruction of MCL alone
- Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
- Reconstruction of multiligament injuries (ACL+MCL)
- 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 years old
- Pregnant
- Revision PCL reconstructions
- Previous or concurrent vascular injury (vascular bypass procedure)
- Associated fractures requiring concurrent surgery
- Concurrent meniscal root or radial repair surgery
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: Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: A Randomized Controlled Trial
This is a prospective randomized controlled trial with the purpose to determine if patients undergoing isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial 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:
- non-weightbearing
- partial weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
- Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing for the first six weeks after surgery.
- Conditions
- Knee Injuries
- Being tested
- Physical Therapy
- Keywords
- anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction
- 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 |
|---|---|---|
| Non-weightbearing for the first six weeks after surgery | Active comparator | Not weightbearing after surgery Receives: Other: Physical Therapy |
| Partial weight -bearing for the first six weeks after surgery | Experimental | Partial weightbearing will be defined as 40% of the patient's body weight. 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 radiographs
Measured: Pre-operative
Gapping (mm) measured on Standard of Care Varus stress radiographs
stress radiographs
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 completionJul 2027 (estimated)
- Study completionJan 2028 (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
- NCT05073276
- Sponsor's protocol ID
- RFL_NWB vs PWB-Multi-Knee Lig
- Status last verified
- Oct 2026
- First submitted
- 13 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
- Non-Weight Bearing Versus Partial Controlled Weightbearing During the First Six Weeks of Rehabilitation After Multiple Knee Ligament Reconstruction: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05073276
- Acronym / sponsor ID
- RFL_NWB vs PWB-Multi-Knee Lig
- Conditions
- Knee Injuries
- Keywords
- anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction
- 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
- Jul 2027 (estimated)
- Study completion
- Jan 2028 (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 isolated posterior cruciate ligament (PCL) reconstruction, or isolated medial collateral ligament (MCL) reconstruction, or combined PCL, anterior cruciate ligament (ACL), fibular collateral ligament (FCL), posterolateral corner (PLC), and MCL reconstructions (or any combination of multiple ligaments) can safely begin partial 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:
- non-weightbearing
- partial weightbearing
An immobilizer brace in extension will be used from post-operative day 0 through 4 and a dynamic stabilizing posterior knee brace (Ossur) will be used from 5 days through 6 months post-surgery to protect against increased posterior translation forces due to gravity and while weightbearing for patients with PCL reconstructions.
Specific Aims
- Primary Aim: To determine if there is clinical equivalence in millimeters of posterior tibial translation on posterior stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Primary Aim: To determine if there is clinical equivalence in millimeters of valgus and/or varus compartment gapping on stress radiographs at six months post-surgery between patients who are non-weightbearing versus partial controlled weightbearing during the first six weeks of post-surgical rehabilitation.
- Secondary Aim: To determine if there is a difference in pain, edema, range of motion, gait, and quadriceps strength between groups.
The current standard of care for posterior cruciate ligament reconstruction and multiligament reconstruction is non-weightbearing 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 |
|---|---|---|
| Non-weightbearing for the first six weeks after surgery | Active comparator | Other: Physical TherapyNot weightbearing after surgery |
| Partial weight -bearing for the first six weeks after surgery | Experimental | Other: Physical TherapyPartial weightbearing will be defined as 40% of the patient's body weight. |
Who may qualify
- Ages
- 14 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- ≥ 14 years old, <60
- Reconstruction of PCL alone
- Reconstruction of MCL alone
- Reconstruction of combined multiligament injuries (PCL+ (FCL, PLC, ACL, MCL))
- Reconstruction of multiligament injuries (ACL+MCL)
Key exclusion criteria (7 listed)
- < 14 years old
- >60 years old
- Pregnant
- Revision PCL reconstructions
- Previous or concurrent vascular injury (vascular bypass procedure)
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 | Non-weightbearing 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 radiographs
Gapping (mm) measured on Standard of Care Varus stress radiographs
Time frame: 6 months post-surgery
stress radiographs
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
Not yet recruiting
Magnesium Alloy Scaffold With Controlled Degradation for Periarticular Bone Defects
Periarticular Bone Defect, Proximal Humerus Fracture
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
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 7 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: 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 McGaver (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.