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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.
Patients will be randomly assigned to one of two rehabilitation protocols for the first six weeks post-surgery:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial weight -bearing for the first six weeks after surgery | Active Comparator | Partial weightbearing will be defined as 40% of the patient's body weight. |
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| Full weight -bearing for the first six weeks after surgery | Experimental | If the patient is randomized to the full weightbearing group, the patient will be instructed about acceptable exercises and activities. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical Therapy | Other | Patient is randomized to the weightbearing group the day after surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gapping (mm) measured on Standard of Care Varus stress radiographs | stress radiograph | Pre-operative |
| Gapping (mm) measured Standard of Care Varus stress radiographs | stress radiograph | 6 months post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Pain Scale (NPS) (0-10 rating) | Pain scale 0-100 | Baseline and 6 months |
| Measurements by physical therapists (Edema, thigh circumference) | Measurements with tape |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Becky Stone | Contact | 952-456-7136 | research@tcomn.com | |
| Kayla Seiffert | Contact | 952-456-7085 | research@tcomn.com |
| Name | Affiliation | Role |
|---|---|---|
| Robert F LaPrade, MD, PhD | Twin Cities Orthopedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Twin Cities Orthopedics | Recruiting | Edina | Minnesota | 55435 | United States |
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| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| 4,7, and 10 months after surgery |
| Measurements by physical therapists (Range of Motion) | Measurements with goniometer | 4,7, and 10 months after surgery |
| Measurements by physical therapists (Quadriceps strength, gait analysis) | Measurements by biomechanics lab | 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 | Baseline, 3 months, 6 months, 1 year |