Knee Function in Patients With Two or More Episodes of Patella Dislocations

NCT02263807 | Completed DMC

• 1 other identifier: 2009/2148
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief Summary

Patients aged 12 - 30 years, with recurrent patella dislocations, are consecutively included into a randomized prospective study. This study comparess the outcome of two forms of treatment for recurrent patella dislocation. One group is offered reconstruction of the medial patellofemoral ligament (MPFL), the second group is offered a standardized training program.

Conditions

Joint Instability

Keywords

Patella luxation

Outcome Measures

Primary Outcomes (1)

• Reoperation

  Numbers of reoperation in the two treatment groups

  2011-2022

Secondary Outcomes (1)

• Patella reluxation

  2011-2022

Study Arms (2)

MPFL group

EXPERIMENTAL

Arthroscopy and MPFL reconstruction

Procedure: MPFL Group; Procedure: Control

Control

ACTIVE COMPARATOR

Arhroscopy and rehabilitation

Procedure: Control

Interventions

MPFL Group PROCEDURE

MPFL reconstruction or standard treatment followed by physiotherapy

Also known as: MPFL surgery

MPFL group

Control PROCEDURE

Arthroscopy followed by active rehabilitation

Also known as: Arthroscopy

Control; MPFL group

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• More than one luxation
• Norwegian citizens
• Unilateral problems
• Age range 12-30 years

You may not qualify if:

• Generalized degenerative changes

Sponsors & Collaborators

• Asbjorn Aroen: lead

Study Sites (2)

Akershus University Hospital

Lørenskog, 1476, Norway

Location

Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (3)

• Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Sivertsen EA, Devitt B, Granan LP, Aroen A. Recurrent lateral patella dislocation affects knee function as much as ACL deficiency - however patients wait five times longer for treatment. BMC Musculoskelet Disord. 2019 Jul 8;20(1):318. doi: 10.1186/s12891-019-2689-7.

  PMID: 31286929 RESULT

• Straume-Naesheim TM, Randsborg PH, Mikaelsen JR, Aroen A. Medial patellofemoral ligament reconstruction is superior to active rehabilitation in protecting against further patella dislocations. Knee Surg Sports Traumatol Arthrosc. 2022 Oct;30(10):3428-3437. doi: 10.1007/s00167-022-06934-3. Epub 2022 Mar 28.

  PMID: 35347375 RESULT

• Nilsgard TL, Oiestad BE, Randsborg PH, Aroen A, Straume-Naesheim TM. Association between single leg hop tests and patient reported outcome measures and patellar instability in patients with recurrent patellar dislocations. BMJ Open Sport Exerc Med. 2023 Dec 30;9(4):e001760. doi: 10.1136/bmjsem-2023-001760. eCollection 2023.

  PMID: 38170085 DERIVED

MeSH Terms

Conditions

Joint Instability

Interventions

Arthroscopy

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Orthopedic Procedures

Study Officials

• Asbjørn Årøen, MD,PhD

  University Hospital, Akershus

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Orthopaedic Surgeon

Study Record Dates

• First Submitted: December 22, 2011
• First Posted: October 13, 2014
• Study Start: May 1, 2010
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

NO (2)