Non- Vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
NCT ID: NCT05073276
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-01-01
2026-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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Non-weightbearing for the first six weeks after surgery
Not weightbearing after surgery
Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Partial weight -bearing for the first six weeks after surgery
Partial weightbearing will be defined as 40% of the patient's body weight.
Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Interventions
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Physical Therapy
Patient is randomized to the weightbearing group the day after surgery.
Eligibility Criteria
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Inclusion Criteria
* 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
* \>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
14 Years
59 Years
ALL
Yes
Sponsors
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Twin Cities Orthopedics
OTHER
Responsible Party
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Principal Investigators
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Robert F LaPrade, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Twin Cities Orthopedics
Locations
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Twin Cities Orthopedics
Edina, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Robert F LaPrade, MD, PhD
Role: backup
Other Identifiers
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RFL_NWB vs PWB-Multi-Knee Lig
Identifier Type: -
Identifier Source: org_study_id
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