Conservative Versus Operative - First Time Patella Dislocations

Official title

Conservative Versus Surgical Management of First Time Patella Dislocations

Overview

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).

Interventions

• Procedure medial patellofemoral reconstruction
  Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.
• Procedure Non-operative group
  Physical therapy by following a specific regimen.

Primary outcome measures

• Change in Kujala Questionnaire Score at 2 weeks [Time frame: Baseline and 2 weeks]
• Change in Kujala Questionnaire Score at 6 weeks [Time frame: Baseline and 6 weeks]
• Change in Kujala Questionnaire Score at 3 months [Time frame: Baseline and 3 months]
• Change in Kujala Questionnaire Score at 6 months [Time frame: Baseline and 6 months]
• Change in Kujala Questionnaire Score at 1 year [Time frame: Baseline and 1 year]
• Change in Kujala Questionnaire Score at 2 years [Time frame: Baseline and 2 years]
• Change in Kujala Questionnaire Score at 5 years [Time frame: Baseline and 5 years]
• Change in Kujala Questionnaire Score at 10 years [Time frame: Baseline and 10 years]
• Time to first re-dislocation [Time frame: Up to 10 years]

Secondary outcome measures (12)

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks [Time frame: Baseline and 2 weeks]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks [Time frame: Baseline and 6 weeks]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months [Time frame: Baseline and 3 months]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months [Time frame: Baseline and 6 months]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year [Time frame: Baseline and 1 Year]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 years [Time frame: Baseline and 2 Years]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 5 years [Time frame: Baseline and 5 Years]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 10 years [Time frame: Baseline and 10 Years]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 2 weeks [Time frame: Baseline and 2 weeks]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 weeks [Time frame: Baseline and 6 weeks]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 3 Months [Time frame: Baseline and 3 Months]
• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) depression computer adaptive test (CAT) at 6 Months [Time frame: Baseline and 6 Months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Columbia University Irving Medical Center — New York

Publications

• 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. PMID 30460463
• 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. PMID 32209111
• 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. PMID 34604425
• 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. PMID 26535352
• 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. PMID 22016458

Identifiers

NCT: NCT05533671 · AAAU0964

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗