NCT05706363

Brief Summary

The purpose of this study is to elucidate surgical techniques for reconstructing MPFL in the treatment of chronic patella instability. The two techniques are conventional technique with the gracillis and screw fixation in the femur which is compared with new technique where the QT tendons and anchor fixation in the femur are used. It would be investigated which technique provides the best stability with the least postoperative pain from the reconstruction and the lowest frequency of patellar reluxation.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress97%
Jul 2017Jul 2026

Study Start

First participant enrolled

July 1, 2017

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2026

Expected
Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

6.9 years

First QC Date

January 5, 2023

Last Update Submit

September 30, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Kujala (Anterior Knee Pain Scale)

    Patient reported outcome score, 0=worst and 100=best

    24 month

Secondary Outcomes (6)

  • Donor site morbidity score, 0=worst and 100=best

    24 month

  • Knee injury and Osteoarthritis Outcome Score (KOOS)

    24 month

  • Lysholm-Tegner (Activity Score)

    24 month

  • Numerical Rating Scale (NRS-pain score)

    24 month

  • Knee pain

    24 month

  • +1 more secondary outcomes

Study Arms (2)

MPFL reconstruction with gracillis graft

ACTIVE COMPARATOR

MPFL reconstructrion with gracillis graft and screw fixation in femur

Procedure: Quadriceps graft

MPFL reconstruction with quadriceps graft

EXPERIMENTAL

MPFL reconstructrion with quadriceps graft and suture anchor fixation in femur

Procedure: Quadriceps graft

Interventions

Using quadriceps graft as new medial patellofemoral ligament graft. Fixated with suture anchor

MPFL reconstruction with gracillis graftMPFL reconstruction with quadriceps graft

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients between 15 and 40 years of age with chronic tendency to lateral patellar dislocation (defined as 2 or more verified dislocation cases)
  • The growth zones must be found closed - verified by MRI scan

You may not qualify if:

  • Patients with known rheumatoid arthritis.
  • Patients with arthroscopically detected osteoarthritis (grade 3 cartilage lesion)
  • Inability to follow a normal rehabilitation regime.
  • Previous ligament surgery in injured knees.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Sports Trauma, Palle Juul-Jensens Boulevard 99

Aarhus N, 8200, Denmark

Location

MeSH Terms

Conditions

Patellar Dislocation

Condition Hierarchy (Ancestors)

Joint DislocationsJoint DiseasesMusculoskeletal DiseasesWounds and InjuriesKnee InjuriesLeg Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 1. Standard: Gracillis graft 2. Intervention: Quadriceps graft
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 31, 2023

Study Start

July 1, 2017

Primary Completion

June 5, 2024

Study Completion (Estimated)

July 30, 2026

Last Updated

October 3, 2025

Record last verified: 2025-09

Locations