DynMPFL - Comparison of Dynamic and Static Medial Patellofemoral Ligament Operation Technique for Recurrent Patellar Dislocation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Patellar Instability
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Change in Kujala score
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This study is to evaluate whether the dynamic Medial Patellofemoral Ligament (MPFL) reconstruction as described by Becher is a successful operation technique to prevent patella instability and restore quality of life. It is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction
Detailed Description
The recurrent dislocation rate of conservatively treated chronic patellar instability is high, therefore, it is recommended to manage it surgically. A frequently used surgical technique is static medial patellofemoral ligament (MPFL) reconstruction (e.g. Schöttle-technique). A novel dynamic surgical technique according to Becher was developed, addressing the most common complications occurring in static reconstruction, which are malpositioning and overtensioning of the graft. This study is to assess and compare clinical and functional outcomes of dynamic and static medial patellofemoral ligament reconstruction.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients treated with isolated dynamic (operation procedure according to Becher et al.using the gracilis tendon) or static MPFL plastic (operation procedure according to Schöttle et al. using the gracilis tendon). MPFL reconstruction will be performed in patients with preceding patella dislocation with: 1) a Patella-Instability-Severity (PIS) score ≤ 3 with concomitant flake fracture or 2) a PIS score ≥ 4 with clinical asymptomatic trochlea dysplasia (patella stability between 30°-60° knee flexion) without other clinically relevant static risk factors.
- •Closed growth plates
Exclusion Criteria
- •Combined procedures with trochleoplasty (high grade trochlea dysplasia, type Dejour C,D with clinical instability between 30° and 60° of knee flexion)
- •combined procedures with cartilage transplantation
- •High grade patellofemoral arthritis (Kellgren Lawrence score ≥3)
- •combined procedures with femoral or tibial osteotomy
- •Clinically eminent valgus axis (\>15° valgus)
- •Femoral internal rotation \>20°, tibial external rotation \>40°
- •Instability of the cruciate or collateral ligaments
- •Known significant musculoskeletal disease
- •Cognitive impairment
Outcomes
Primary Outcomes
Change in Kujala score
Time Frame: up to 24 months
Patient reported knee function and anterior knee pain as assessed with the Kujala score at preoperative screening, at the hospitalization time and four postoperative follow ups . The Kujala scale consists of 13 questions covering a range of physical symptoms and limitations that are presented in a multiple choice answer format, with a different point value assigned to each answer. The maximum score is 100, with higher scores indicating better function.
Secondary Outcomes
- Number of revision surgery(From MPFL surgery to occurring revision surgery (up to 24 months))
- Change in EQ-5D-5L from preoperative screening, at the hospitalization time and four postoperative follow ups EQ-5D- EQ-5D-5L(up to 24 months)
- Hospitalization time(During hospitalization (up to 1 month))
- Change in gait asymmetry(Preoperatively and 1 year postoperative)
- Number of recurrent patella dislocation(From MPFL surgery to occurring recurrent patella dislocation (up to 24 months))
- Number of complications (other than revision surgery, e.g. infection, wound healing disorder)(From MPFL surgery to occurring complication (up to 24 months))
- Change in Banff-II-score from preoperative screening, at the hospitalization time and four postoperative follow ups(up to 24 months)
- Operation time(During MPFL surgery (up to 1 day))
- Change in isokinetic muscle strength(Preoperatively and 1 year postoperative)
- Change in timing of muscle activity(Preoperatively and 1 year postoperative)
- Change in single legged drop test(Preoperatively and 1 year postoperative)
- Change in International Knee Documentation Committee (IKDC)-2000 from preoperative screening, at the hospitalization time and four postoperative follow ups(up to 24 months)
- Change in pain level using the numeric rating scale from preoperative screening, at the hospitalization time and four postoperative follow ups(up to 24 months)