Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy.
- Who it may be relevant to
- Registry conditions: Knee Injuries. Basic parameters: 14 years — 59 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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:
1. non-weightbearing 2. 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
1. 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. 2. 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. 3. 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.
Interventions
- Other Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Primary outcome measures
- Gapping (mm) measured on Standard of Care Varus stress radiographs [Time frame: Pre-operative]
- Gapping (mm) measured on Standard of Care Varus stress radiographs [Time frame: 6 months post-surgery]
Secondary outcome measures (5)
- 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]
Eligibility criteria
Inclusion criteria
- ≥ 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.
Exclusion criteria
- < 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Twin Cities Orthopedics — Edina
Identifiers
NCT: NCT05073276 · RFL_NWB vs PWB-Multi-Knee Lig