Radiographic and Patient Reported Outcomes Following Joint Arthrodesis Following the Use of the SpeedPlate™ Rapid Compression Implants: An Ambidirectional Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Joint Arthrodesis
- Sponsor
- Treace Medical Concepts, Inc.
- Enrollment
- 92
- Locations
- 5
- Primary Endpoint
- Evaluate union vs non-union
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
Post-market, observational, multicenter, unblinded, ambidirectional cohort study to evaluate outcomes of study participants treated with the SpeedPlate™ product.
Up to 200 participants will be treated in this study at (up to) 15 clinical sites.
Patients 14 years of age or older that have had MTP and/or TMT joint fixation with the SpeedPlate™ Rapid Compression Implants will be eligible to participate based on the inclusion and exclusion criteria defined in this protocol.
Detailed Description
The objectives of this study are to evaluate: 1. Healing/union rates following joint fixation using the SpeedPlate™ Rapid Compression Implants 2. Whether early weight-bearing (WB) following joint fixation using the SpeedPlate™ Rapid Compression Implants affects the healing/union rates 3. Quality of life, pain scores and patient satisfaction following joint arthrodesis using the SpeedPlate™ Rapid Compression Implants
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients satisfying the following criteria will be considered and eligible for participation:
- •Patients who have had MTP and/or TMT joint fixation using at least one SpeedPlate™ Rapid Compression Implant (Index Procedure);
- •Males and females ages 14 years of age or older at the time of the Index Procedure;
- •Patients who have completed at least their 6-week post-operative visit but have not yet completed their 12-month post-operative visit;
- •Adequate pre-operative AP and lateral weight-bearing radiographs collected within 6 months of the Index Procedure;
- •Patients must be capable of completing self-administered questionnaires;
- •Willing and able to provide written informed consent.
Exclusion Criteria
- •Patients satisfying the following criteria will not be eligible for participation:
- •Female patients of childbearing potential with positive pregnancy result at time of consent;
- •Unwilling or unable to schedule and return for follow-up visits;
- •Surgery for MTP or TMT joint arthrodesis on operative foot prior to Index Procedure;
- •Joint arthrodesis using other plating constructs in addition to the SpeedPlate™ Implant(s) at MTP or TMT joint at the time of Index Procedure;
- •Surgeries on operative foot involving fusion of the foot or ankle joints prior to, or at the time of, Index Procedure (other than hammertoe or lesser toes/digits);
- •Clinically significant neuropathy at time of Index Procedure;
- •Untreated Moderate - Severe Osteoarthritis of 1st, 2nd, or 3rd TMT or MTP during the Index Procedure;
- •Untreated Moderate - Severe Osteoarthritis of the foot or ankle outside of the 1st, 2nd or 3rd TMT or MTP joints at the time of Index Procedure;
- •BMI \>40 kg/m² at time of Index Procedure;
Outcomes
Primary Outcomes
Evaluate union vs non-union
Time Frame: 12 Months
Evaluate clinical/radiographic healing (union vs non-unio). Non-union is defined as radiographic lucency and clinical pain at the 1st, 2nd, and/or 3rd TMT or MTP joint at 12 months post Index.
Secondary Outcomes
- Evaluate non-surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.(24 Months)
- Evaluate the Intermetatarsal Angle(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate time to start weight-bearing in shoes.(Days after surgery - on average up to 6 weeks)
- Evaluate patient-reported quality of life, post surgery.(6 Months, 12 Months, 24 Months)
- Evaluate patient-reported satisfaction, post surgery.(12 Months, 24 Months)
- Evaluate surgical clinical complications or health conditions that could affect outcomes related to the implants or procedure.(24 Months)
- Evaluate the Tibial Sesamoid(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate time to start weight-bearing in a boot.(Days after surgery - on average up to 2 weeks)
- Evaluate time to start unrestricted activity.(Days after surgery - on average up to 4 months)
- Evaluate the Hallux Valgus Angle(6 Weeks, 3-4 Months, 6 Months, 12 Months, 24 Months)
- Evaluate patient-reported pain, post surgery.(6 Months, 12 Months, 24 Months)