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Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

Primary Purpose

Knee Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Physical Therapy
Sponsored by
Twin Cities Orthopedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring fibular collateral ligament (FCL), anterior cruciate ligament (ACL)

Eligibility Criteria

14 Years - 59 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • < 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

Sites / Locations

  • Twin Cities OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Partial weight -bearing for the first six weeks after surgery

Full weight -bearing for the first six weeks after surgery

Arm Description

Partial weightbearing will be defined as 40% of the patient's body weight.

If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.

Outcomes

Primary Outcome Measures

Gapping (mm) measured on Standard of Care Varus stress radiographs
stress radiograph
Gapping (mm) measured Standard of Care Varus stress radiographs
stress radiograph

Secondary Outcome Measures

Numeric Pain Scale (NPS) (0-10 rating)
Pain scale 0-100
Measurements by physical therapists (Edema, thigh circumference)
Measurements with tape
Measurements by physical therapists (Range of Motion)
Measurements with goniometer
Measurements by physical therapists (Quadriceps strength, gait analysis)
Measurements by biomechanics lab
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

Full Information

First Posted
September 14, 2021
Last Updated
April 12, 2023
Sponsor
Twin Cities Orthopedics
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1. Study Identification

Unique Protocol Identification Number
NCT05073263
Brief Title
Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Twin Cities Orthopedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
fibular collateral ligament (FCL), anterior cruciate ligament (ACL)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Partial weight -bearing for the first six weeks after surgery
Arm Type
Active Comparator
Arm Description
Partial weightbearing will be defined as 40% of the patient's body weight.
Arm Title
Full weight -bearing for the first six weeks after surgery
Arm Type
Experimental
Arm Description
If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
Patient is randomized to the weightbearing group the day after surgery.
Primary Outcome Measure Information:
Title
Gapping (mm) measured on Standard of Care Varus stress radiographs
Description
stress radiograph
Time Frame
Pre-operative
Title
Gapping (mm) measured Standard of Care Varus stress radiographs
Description
stress radiograph
Time Frame
6 months post-surgery
Secondary Outcome Measure Information:
Title
Numeric Pain Scale (NPS) (0-10 rating)
Description
Pain scale 0-100
Time Frame
Baseline and 6 months
Title
Measurements by physical therapists (Edema, thigh circumference)
Description
Measurements with tape
Time Frame
4,7, and 10 months after surgery
Title
Measurements by physical therapists (Range of Motion)
Description
Measurements with goniometer
Time Frame
4,7, and 10 months after surgery
Title
Measurements by physical therapists (Quadriceps strength, gait analysis)
Description
Measurements by biomechanics lab
Time Frame
4,7, and 10 months after surgery
Title
Patient reported outcome scores
Description
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
Time Frame
Baseline, 3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ≥ 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. Exclusion Criteria: < 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Becky Stone
Phone
952-456-7136
Email
research@tcomn.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kayla Seiffert
Phone
952-456-7085
Email
research@tcomn.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert F LaPrade, MD, PhD
Organizational Affiliation
Twin Cities Orthopedics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Twin Cities Orthopedics
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Stone
Phone
952-456-7136
Email
research@tcomn.com
First Name & Middle Initial & Last Name & Degree
Robert F LaPrade, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Full Vs Partial Weightbearing During the First Six Weeks of Rehab. After Fibular Collateral Ligament Reconstruction

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