Repair of Medial Patellofemoral Ligament Compared to Conservative Treatment for First Time Patella Dislocation

NCT02185001 | Terminated

• 1 other identifier: TLKC-0001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The forces involved in a patella dislocation event can cause significant collateral damage involving the articular cartilage of the patella femoral joint. As a result, prevention of recurrent patella dislocation and the associated disability and morbidity has generated significant interest in the orthopedic community. Historically, nonoperative treatment for first time patella dislocation has been problematic due to high redislocation rates. Nonoperative protocols generally involve bracing and/or immobilization, followed by physical therapy (1). Surgical approaches to recurrent patella dislocation, both soft tissue and boney realignment operations, have also had mixed results, including low success rates, associated complications, and variable rates of return to functional activity (2,3,4). This study is intended to compare the outcomes of a relatively low-risk Medial Patellofemoral Ligament (MPFL) direct repair procedure to conservative treatment. Methods/Design: This study is designed as a two arm randomized prospective trial. Approximately fifty subjects will be randomly assigned to either a surgical or non-operative arm by means of a computer randomized allocation program. All subjects will have X-Ray Images and Magnetic Resonance Imaging (MRI) to determine the site of the MPFL damage, and to determine if any excluding conditions exist. Subjects randomized to the surgical group will have repair of the MPFL. Routine aftercare will consist of physical therapy in a clinic that has agreed to follow our protocol. Subjects randomized to the nonoperative group will receive 2 weeks of patellar immobilization, followed by patellar stabilization bracing with physical therapy for approximately 12 weeks. Physical therapy will progress through five phases with the goal of gait normalization, full range of motion and return to sport. Both arms will be given outcome questionnaires and physical activity assessments before treatment, and at one, three, six, twelve, and twenty four month intervals. Discussion: This prospective randomized trial will investigate the results of direct repair of the medial patellofemoral ligament and conservative treatment by applying subjective outcome measures (Kujala scores), and exam findings to determine MPFL functional restoration or redislocation. Subjects will be examined in the clinic setting at 10 days, one month, and six months post trauma. Any reported recurrent dislocation or subluxation event will be documented during recovery. All subjects will receive merchant x-ray views at 3 months with manual lateral translation of the patella.

Conditions

Dislocated Patella; Torn Medial Patellofemoral Ligament

Keywords

Medial patellofemoral ligament; MPFL; Repair; Patellar dislocation; Knee

Outcome Measures

Primary Outcomes (1)

• Patient Reported Change in Patellar Stability, Subluxation, or Recurrent Dislocation.

  Subjects will be divided into 3 groups relating to patellar stability: 1. Recurrence, indicating that the patient had a recurrent patellofemoral dislocation (total loss of congruence between the patella and trochlea) prior to 24 months. 2. Unstable, indicating that the patient's knee presented with a positive apprehension test or showed signs of subluxation prior to 24 months, but without recurrent dislocation. 3. Stable, indicating that the patient's knee did not show positive signs of episodes of subluxation at 24 months.

  24 months, or as reported by subject

Secondary Outcomes (1)

• Subjective Outcome Measurement (Kujala Test)

  1, 3, 6, 12, and 24 months

Study Arms (2)

Surgical Treatment Group

ACTIVE COMPARATOR

Direct Medial Patellofemoral Ligament (MPFL) Repair

Procedure: Direct Medial Patellofemoral Ligament (MPFL) Repair

Conservative Treatment Group

ACTIVE COMPARATOR

Immobilization, stabilization bracing, and physical therapy

Procedure: Physical therapy

Interventions

Direct Medial Patellofemoral Ligament (MPFL) Repair PROCEDURE

The MPFL will be repaired directly at the site of the traumatic injury.

Also known as: Surgical Treatment Group

Surgical Treatment Group

Physical therapy PROCEDURE

Patellar immobilization, stabilization, and strengthening under the direction and guidance of the physician and physical therapist.

Also known as: Physiotherapy

Conservative Treatment Group

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A first patellofemoral traumatic dislocation
• A need for reduction
• An absence of fractures on x-ray exam of the frontal and lateral knee and axial patella
• An absence of knee ligament lesions with surgical indications (with the exception of the MPFL)
• No previous knee surgery

You may not qualify if:

• A prior episode of patellofemoral dislocation
• Fractures on x-ray exam of the frontal and lateral knee and axial patella Prior surgery on the knee
• Tibial tuberosity-trochlear groove distance greater than 20mm
• Current pregnancy or plan to become pregnant during the study period.

Sponsors & Collaborators

• Orthopedic Specialty Institute: lead

Study Sites (1)

The Lyman Knee Clinic

Coeur d'Alene, Idaho, 83814, United States

Location

Related Publications (10)

• Maenpaa H, Huhtala H, Lehto MU. Recurrence after patellar dislocation. Redislocation in 37/75 patients followed for 6-24 years. Acta Orthop Scand. 1997 Oct;68(5):424-6. doi: 10.3109/17453679708996255.

  PMID: 9385239 BACKGROUND

• Colvin AC, West RV. Patellar instability. J Bone Joint Surg Am. 2008 Dec;90(12):2751-62. doi: 10.2106/JBJS.H.00211.

  PMID: 19047722 BACKGROUND

• Arendt EA, Fithian DC, Cohen E. Current concepts of lateral patella dislocation. Clin Sports Med. 2002 Jul;21(3):499-519. doi: 10.1016/s0278-5919(02)00031-5.

  PMID: 12365240 BACKGROUND

• Arnbjornsson A, Egund N, Rydling O, Stockerup R, Ryd L. The natural history of recurrent dislocation of the patella. Long-term results of conservative and operative treatment. J Bone Joint Surg Br. 1992 Jan;74(1):140-2. doi: 10.1302/0301-620X.74B1.1732244.

  PMID: 1732244 BACKGROUND

• Aglietti P, Buzzi R, De Biase P, Giron F. Surgical treatment of recurrent dislocation of the patella. Clin Orthop Relat Res. 1994 Nov;(308):8-17.

  PMID: 7955706 BACKGROUND

• Sillanpaa PJ, Peltola E, Mattila VM, Kiuru M, Visuri T, Pihlajamaki H. Femoral avulsion of the medial patellofemoral ligament after primary traumatic patellar dislocation predicts subsequent instability in men: a mean 7-year nonoperative follow-up study. Am J Sports Med. 2009 Aug;37(8):1513-21. doi: 10.1177/0363546509333010. Epub 2009 Apr 17.

  PMID: 19376939 BACKGROUND

• Guerrero P, Li X, Patel K, Brown M, Busconi B. Medial patellofemoral ligament injury patterns and associated pathology in lateral patella dislocation: an MRI study. Sports Med Arthrosc Rehabil Ther Technol. 2009 Jul 30;1(1):17. doi: 10.1186/1758-2555-1-17.

  PMID: 19643022 BACKGROUND

• Balcarek P, Walde TA, Frosch S, Schuttrumpf JP, Wachowski MM, Sturmer KM. MRI but not arthroscopy accurately diagnoses femoral MPFL injury in first-time patellar dislocations. Knee Surg Sports Traumatol Arthrosc. 2012 Aug;20(8):1575-80. doi: 10.1007/s00167-011-1775-7. Epub 2011 Nov 18.

  PMID: 22095485 BACKGROUND

• Tom A, Fulkerson JP. Restoration of native medial patellofemoral ligament support after patella dislocation. Sports Med Arthrosc Rev. 2007 Jun;15(2):68-71. doi: 10.1097/JSA.0b013e31803035d3.

  PMID: 17505320 BACKGROUND

• Camanho GL, Viegas Ade C, Bitar AC, Demange MK, Hernandez AJ. Conservative versus surgical treatment for repair of the medial patellofemoral ligament in acute dislocations of the patella. Arthroscopy. 2009 Jun;25(6):620-5. doi: 10.1016/j.arthro.2008.12.005. Epub 2009 Feb 26.

  PMID: 19501292 BACKGROUND

MeSH Terms

Conditions

Patellar Dislocation

Interventions

Wound Healing; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena; Therapeutics; Rehabilitation

Study Officials

• Jeffrey R Lyman, MD

  Orthopedic Specialty Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 9, 2014
• Study Start: October 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: March 9, 2017

Record last verified: 2017-03

Locations

US (1)