Conservative Versus Operative - First Time Patella Dislocations

NCT05533671 | Not Yet Recruiting

• 1 other identifier: AAAU0964
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Patella Dislocation

Outcome Measures

Primary Outcomes (9)

• Change in Kujala Questionnaire Score at 2 weeks

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 2 weeks

• Change in Kujala Questionnaire Score at 6 weeks

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 6 weeks

• Change in Kujala Questionnaire Score at 3 months

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 3 months

• Change in Kujala Questionnaire Score at 6 months

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 6 months

• Change in Kujala Questionnaire Score at 1 year

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 1 year

• Change in Kujala Questionnaire Score at 2 years

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 2 years

• Change in Kujala Questionnaire Score at 5 years

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 5 years

• Change in Kujala Questionnaire Score at 10 years

  The Kujala questionnaire assess symptoms and limitations that a patient may experience as a result of a knee injury. Scores range from 0-100 with a higher score indicating less limitation. Scores will be reported at each time point.

  Baseline and 10 years

• Time to first re-dislocation

  Time to first re-dislocation following intervention, measured in weeks

  Up to 10 years

Secondary Outcomes (42)

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 2 weeks

  Baseline and 2 weeks

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 weeks

  Baseline and 6 weeks

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 3 months

  Baseline and 3 months

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 6 months

  Baseline and 6 months

• Change in the Patient-Reported Outcome Measurement Information System (PROMIS) Physical Function (PF) at 1 year

  Baseline and 1 Year

Study Arms (2)

Operative Group

EXPERIMENTAL

This group will have surgical procedure called a medial patellofemoral reconstruction where the kneecap is anchored back into its correct position)

Procedure: medial patellofemoral reconstruction

Non-operative group

ACTIVE COMPARATOR

This group will have physical therapy for their knee dislocation by following a specific rehabilitation plan.

Procedure: Non-operative group

Interventions

medial patellofemoral reconstruction PROCEDURE

Surgery to correct dislocated (knocked out of place) knee cap. This surgery anchors the kneecap back into the correct position and supports the kneecap.

Operative Group

Non-operative group PROCEDURE

Physical therapy by following a specific regimen.

Non-operative group

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Knee Injuries; Leg Injuries

Study Officials

• David Trofa, MD

  Associate Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Trofa, MD

CONTACT

212 305 5974; dpt2103@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 4, 2022
• First Posted: September 9, 2022
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2032
• Study Completion (Estimated): September 1, 2032
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)