Clinical trial NCT05533671: Conservative Versus Operative - First Time Patella Dislocations
Official title: Conservative Versus Surgical Management of First Time Patella Dislocations
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patella Dislocation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2022-09-09
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a prospective randomized controlled trial investigating outcomes (recurrent dislocation rates and participant reported outcomes) in two groups of participants following a primary patella dislocation. Half of the participants will be randomized to operative intervention with a standard medial patellofemoral ligament (MPFL) reconstruction and the other half will be randomized to conservative management with a standardized rehabilitation protocol (non-operative group).
Primary purpose: TREATMENT

Brief summary: There is no consensus regarding whether rehabilitation or surgical management is best for the management of a primary patellar dislocation. Consequently this prospective randomized controlled aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Detailed description: Long term sequalae of first-time patellar dislocations include recurrent knee instability, osteoarthritis, and a decreased quality of life, and yet there is no consensus on the best management for these patients. Despite an increasing trend toward investigating operative vs non-operative management of primary patellar dislocations, scarce level-1 evidence exists comparing the two treatment modalities. Indeed, the few meta-analyses suggesting improved outcomes of operative treatment for first time patellar dislocations mainly utilize retrospective cohort studies. A randomized-controlled trial of 39 patients with primary patellar dislocations with a mean age of 24 (21 operative vs 18 non-operative), found decreased rates of recurrent knee instability after a mean follow up of 44 months (0% in operative vs 35% in non-operative), and a higher Kujala knee score (88.9 in operative vs 70.8 in non-operative; p=0.001). A controlled but non-randomized prospective controlled trial among 69 patients with a mean age of 18, (30 operative vs 39 non-operative), found lower rates of recurrent knee instability after a mean follow up of 24 months (0% in operative vs 20.5% in non-operative and a higher Kujala knee score (86.3 in operative group vs 80.03 in non-operative; p \<0.05).The scarce randomized, prospective data investigating the appropriate management in primary patellar dislocations underscores the importance of the current study in providing high-quality evidence to the debate of how to best manage primary patellar dislocations. This study aims to compare the incidence of recurrent knee dislocations and patient reported outcomes of patients with primary patellar dislocations managed with surgery (medial patellofemoral ligament reconstruction) compared to non-operative management (a standardized rehabilitation protocol, control group).

Eligibility criteria: Inclusion Criteria:

* age 12 and older
* patients seen by the Columbia University Shoulder Elbow and Sports Medicine Service
* patients who experience a first-time patella dislocation

Exclusion Criteria:

* coexistent ligament injury or osteochondral fracture necessitating acute surgical intervention
* previous knee surgery
* knee instability prior to injury
* inability or unwillingness to adhere to study participate
* lost to follow up

Primary outcomes:
measure: Change in Kujala Questionnaire Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Kujala Questionnaire Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Kujala Questionnaire Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Kujala Questionnaire Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Kujala Questionnaire Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Kujala Questionnaire Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Kujala Questionnaire Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Kujala Questionnaire Score at 10 years
timeFrame: Baseline and 10 years
measure: Time to first re-dislocation
timeFrame: Up to 10 years
Secondary outcomes:
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months
timeFrame: Baseline and 3 months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months
timeFrame: Baseline and 6 months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year
timeFrame: Baseline and 1 Year
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years
timeFrame: Baseline and 2 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years
timeFrame: Baseline and 5 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years
timeFrame: Baseline and 10 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months
timeFrame: Baseline and 3 Months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months
timeFrame: Baseline and 6 Months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 1 Year
timeFrame: Baseline and 1 Year
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 Years
timeFrame: Baseline and 2 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 5 Years
timeFrame: Baseline and 5 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 10 Years
timeFrame: Baseline and 10 Years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 3 months
timeFrame: Baseline and 3 months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 6 months
timeFrame: Baseline and 6 months
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 1 year
timeFrame: Baseline and 1 year
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 2 years
timeFrame: Baseline and 2 years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 5 years
timeFrame: Baseline and 5 years
measure: Change in the Patient-Reported Outcome Measurement Information System (PROMIS) pain interference (PI) computer adaptive test (CAT) at 10 years
timeFrame: Baseline and 10 years
measure: Percentage of participants who re-dislocate their knee after treatment at each time point within each group
timeFrame: 2 weeks 6 weeks, 3 months, 6 months, 1 year, 2 years, 5 years and 10 years
measure: Time to return to full activity or sports for each group
timeFrame: Up to 10 years
measure: Change in the Banff Patella Instability Instrument at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in the Banff Patella Instability Instrument at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in the Banff Patella Instability Instrument at 3 months
timeFrame: Baseline and 3 months
measure: Change in the Banff Patella Instability Instrument at 6 months
timeFrame: Baseline and 6 months
measure: Change in the Banff Patella Instability Instrument at 1 year
timeFrame: Baseline and 1 year
measure: Change in the Banff Patella Instability Instrument at 2 years
timeFrame: Baseline and 2 years
measure: Change in the Banff Patella Instability Instrument at 5 years
timeFrame: Baseline and 5 years
measure: Change in the Banff Patella Instability Instrument at 10 years
timeFrame: Baseline and 10 years
measure: Change in Norwich Patellar Instability Score at 2 weeks
timeFrame: Baseline and 2 weeks
measure: Change in Norwich Patellar Instability Score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change in Norwich Patellar Instability Score at 3 months
timeFrame: Baseline and 3 months
measure: Change in Norwich Patellar Instability Score at 6 months
timeFrame: Baseline and 6 months
measure: Change in Norwich Patellar Instability Score at 1 year
timeFrame: Baseline and 1 year
measure: Change in Norwich Patellar Instability Score at 2 years
timeFrame: Baseline and 2 years
measure: Change in Norwich Patellar Instability Score at 5 years
timeFrame: Baseline and 5 years
measure: Change in Norwich Patellar Instability Score at 10 years
timeFrame: Baseline and 10 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Assistant Professor of Orthopedic Surgery
name: David Trofa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng X, Hu Y, Xie P, Cui M, Ma X, Feng YE, Gu J, Gao S. Surgical medial patellofemoral ligament reconstruction versus non-surgical treatment of acute primary patellar dislocation: a prospective controlled trial. Int Orthop. 2019 Jun;43(6):1495-1501. doi: 10.1007/s00264-018-4243-x. Epub 2018 Nov 20.
citation: Xing X, Shi H, Feng S. Does surgical treatment produce better outcomes than conservative treatment for acute primary patellar dislocations? A meta-analysis of 10 randomized controlled trials. J Orthop Surg Res. 2020 Mar 24;15(1):118. doi: 10.1186/s13018-020-01634-5.
citation: Liu Z, Yi Q, He L, Yao C, Zhang L, Lu F, Zhang X, Wu M, Geng B, Xia Y, Jiang J. Comparing Nonoperative Treatment, MPFL Repair, and MPFL Reconstruction for Patients With Patellar Dislocation: A Systematic Review and Network Meta-analysis. Orthop J Sports Med. 2021 Sep 28;9(9):23259671211026624. doi: 10.1177/23259671211026624. eCollection 2021 Sep.
citation: Mackay ND, Smith NA, Parsons N, Spalding T, Thompson P, Sprowson AP. Medial Patellofemoral Ligament Reconstruction for Patellar Dislocation: A Systematic Review. Orthop J Sports Med. 2014 Aug 8;2(8):2325967114544021. doi: 10.1177/2325967114544021. eCollection 2014 Aug.
citation: Bitar AC, Demange MK, D'Elia CO, Camanho GL. Traumatic patellar dislocation: nonoperative treatment compared with MPFL reconstruction using patellar tendon. Am J Sports Med. 2012 Jan;40(1):114-22. doi: 10.1177/0363546511423742. Epub 2011 Oct 19.