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Non- vs Partial Controlled Weightbearing After Multiple Knee 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 anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction

Eligibility Criteria

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

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

Sites / Locations

  • Twin Cities OrthopedicsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Non-weightbearing for the first six weeks after surgery

Partial weight -bearing for the first six weeks after surgery

Arm Description

Not weightbearing after surgery

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

Outcomes

Primary Outcome Measures

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

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 13, 2021
Last Updated
April 12, 2023
Sponsor
Twin Cities Orthopedics
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1. Study Identification

Unique Protocol Identification Number
NCT05073276
Brief Title
Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction
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
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
anterior cruciate ligament (ACL), Multiple Knee Ligament Reconstruction

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
Non-weightbearing for the first six weeks after surgery
Arm Type
Active Comparator
Arm Description
Not weightbearing after surgery
Arm Title
Partial weight -bearing for the first six weeks after surgery
Arm Type
Experimental
Arm Description
Partial weightbearing will be defined as 40% of the patient's body weight.
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 radiographs
Time Frame
Pre-operative
Title
Gapping (mm) measured on Standard of Care Varus stress radiographs
Description
stress radiographs
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Becky McGaver
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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Non- vs Partial Controlled Weightbearing After Multiple Knee Ligament Reconstruction

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