Patellar LuxationNCT04438109
Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL)
An observational study of Patellar Luxation and Patellar Instability, run by Hannover Medical School at 1 site in Germany.
Trial summary
In a single surgical center, 213 consecutive patients with 221 knees were surgically treated for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes anserinus while maintaining the proximal origin… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patellar Luxation, Patellar Instability
- How many people
- 152 participants
- Where
- 1 siteGermany
- Study dates
- 12 Apr 2019to 27 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction.
Who may be able to join
- Patients with MPFL reconstruction and possible accompanying interventions
- Age >18 years
Who cannot join
- Known hereditary connective tissue diseases (e.g. Ehlers-Danlos syndrome)
- Known neurogenic diseases
- Significant further musculoskeletal disorders
Trial locations and contacts
1 site in 1 country.
Germany1 site
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, 30625
About this study
Official title: Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL) - a Retrospective Case Series
In a single surgical center, 213 consecutive patients with 221 knees were surgically treated for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was performed by oblique transpatellar tunnel transfer and tenodesis screw. Follow-up data including Kujala-, BANFF- and Norwich patellar instability score as well as Return-to-Sport and pain level were collected at a minimum follow-up of 2 years
Read the detailed description
Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction. The included surgeries were performed from 07/2010 to 12/2016 in a single orthopedic hospital.
Inclusion criteria:
- Dynamic MPFL-reconstruction (primary and revision surgery) including cartilage procedure
- Age of 18 years or older at a minimum of 24 months follow up
Exclusion criteria:
- Diagnosis of connective tissue disease
- Neurological diseases including patella associated spasticity and
- Concomitant alignment correction surgery including femoral/tibial osteotomy, trochleoplasty and tibial tubercle transfer 213 Patients with 221 knees (8 bilateral) met the inclusion criteria. All patients were contacted by mail or phone to independently answer questionnaires.
Surgical technique:
The technique was performed according to the description by Ostermeier et al.. Briefly, the gracilis tendon is detached at its insertion site at the pes anserinus after opening the sartorius fascia. Instead of transferring the tendon through a subligamentous tunnel of the medial collateral ligament, as detailed in the original description of the technique, the tendon was passed around the incised sartorius fascia. From around the sartorius fascia the gracilis tendon is shuttled subcutaneously to the medial patellar margin, allowing the sartorius fascia to act as a pulley for the transferred tendon. Due to the dynamic reconstruction technique, the course of the graft appears to be more oblique compared to the static technique with femoral fixation at Schöttle's point. Fixation of the tendon is achieved by passing it through a transpatellar drill hole extending from the proximal medial patellar margin to the lateral patellar margin. The tendon is then tensioned with the knee in 30 degrees of flexion and fixed with a bioabsorbable tenodesis screw.
Data collection was performed by self-administered questionnaires, which were sent to the patients.
The medical records and radiographs of all patients were reviewed for demographic information (age, sex) and to identify complications related to the surgical procedure. Complications were categorized as major if the patient returned to the operating room or required hospitalization after the index procedure. Complications were categorized as minor complications if they were treated on an outpatient basis.
Rating of the results was performed using the Kujala score, the Norwich Patellar Instability Score and the BANFF Score.
Pain level was recorded using the visual analogue scale (VAS, 0 = no pain, 10 = severe pain). General satisfaction with treatment outcomes was evaluated by questionnaire (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor, 6 = very poor) and by asking patients whether they would undergo the procedure again. Furthermore, information on patient characteristics, recurrence of dislocation, revision surgery, and other postoperative complications were recorded.
Postoperative x-rays were analyzed concerning intraoperative complications (e.g. fractures or patellar drill hole malpositioning).
- Conditions
- Patellar Luxation, Patellar Instability
- Keywords
- knee, MPFL reconstruction, patella instability, patella dislocation
- Medical subject headings
- Patellar Dislocation
What is being measured
The primary outcome is the main question the study is designed to answer.
Kujala score
The Kujala Anterior Knee Pain Scale is a patient reported assessment of patellofemoral disorders that assesses subjective symptoms and functional limitations.
The score consists of 13 questions that add up to a total of 100 points. Minimum: 0 (worst), Maximum: 100 (best)
Measured: 24 months postoperative
Norwich Patellar Instability Score (NPI Score)
The Norwich Patellar Instability Score is a patient reported assessment of patellofemoral instability.
The score consists of 19 questions with a special weighting for every question. The results are presented in percent. Range: 0% (best) to 100% (worst)
Measured: 24 months postoperative
BANFF Score
The Banff Score is a patient reported assessment of patellofemoral disorders that assesses patella instability.
The score consists of 23 questions. Minimum: 0 (worst), Maximum: 100 (best)
Measured: 24 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start12 Apr 2019
- Primary completion12 Apr 2019
- Study completion27 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patellar LuxationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438109
- Sponsor's protocol ID
- 8262_BO_K_2019
- Status last verified
- Mar 2021
- First submitted
- 16 Jun 2020
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Horstmann H, Karkosch R, Berg A, Becher C, Petri M, Smith T. The novel dynamic MPFL-reconstruction technique: cheaper and better? Arch Orthop Trauma Surg. 2022 Aug;142(8):2011-2017. doi: 10.1007/s00402-021-04198-z. Epub 2021 Oct 11.
PubMed 34633513
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of the Dynamic Reconstruction of the Medial Patellofemoral Ligament (MPFL) - a Retrospective Case Series
- ClinicalTrials.gov ID
- NCT04438109
- Acronym / sponsor ID
- 8262_BO_K_2019
- Conditions
- Patellar Luxation, Patellar Instability
- Keywords
- knee, MPFL reconstruction, patella instability, patella dislocation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 12 Apr 2019 (actual)
- Study completion
- 27 Feb 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In a single surgical center, 213 consecutive patients with 221 knees were surgically treated for recurrent lateral patellar dislocation between 07/2010 and 12/2016. All patients obtained dynamic reconstruction of the MPFL with detachment of the gracilis tendon at the pes anserinus while maintaining the proximal origin at the gracilis muscle. Patellar fixation was performed by oblique transpatellar tunnel transfer and tenodesis screw. Follow-up data including Kujala-, BANFF- and Norwich patellar instability score as well as Return-to-Sport and pain level were collected at a minimum follow-up of 2 years
Detailed description
Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction. The included surgeries were performed from 07/2010 to 12/2016 in a single orthopedic hospital.
Inclusion criteria:
- Dynamic MPFL-reconstruction (primary and revision surgery) including cartilage procedure
- Age of 18 years or older at a minimum of 24 months follow up
Exclusion criteria:
- Diagnosis of connective tissue disease
- Neurological diseases including patella associated spasticity and
- Concomitant alignment correction surgery including femoral/tibial osteotomy, trochleoplasty and tibial tubercle transfer 213 Patients with 221 knees (8 bilateral) met the inclusion criteria. All patients were contacted by mail or phone to independently answer questionnaires.
Surgical technique:
The technique was performed according to the description by Ostermeier et al.. Briefly, the gracilis tendon is detached at its insertion site at the pes anserinus after opening the sartorius fascia. Instead of transferring the tendon through a subligamentous tunnel of the medial collateral ligament, as detailed in the original description of the technique, the tendon was passed around the incised sartorius fascia. From around the sartorius fascia the gracilis tendon is shuttled subcutaneously to the medial patellar margin, allowing the sartorius fascia to act as a pulley for the transferred tendon. Due to the dynamic reconstruction technique, the course of the graft appears to be more oblique compared to the static technique with femoral fixation at Schöttle's point. Fixation of the tendon is achieved by passing it through a transpatellar drill hole extending from the proximal medial patellar margin to the lateral patellar margin. The tendon is then tensioned with the knee in 30 degrees of flexion and fixed with a bioabsorbable tenodesis screw.
Data collection was performed by self-administered questionnaires, which were sent to the patients.
The medical records and radiographs of all patients were reviewed for demographic information (age, sex) and to identify complications related to the surgical procedure. Complications were categorized as major if the patient returned to the operating room or required hospitalization after the index procedure. Complications were categorized as minor complications if they were treated on an outpatient basis.
Rating of the results was performed using the Kujala score, the Norwich Patellar Instability Score and the BANFF Score.
Pain level was recorded using the visual analogue scale (VAS, 0 = no pain, 10 = severe pain). General satisfaction with treatment outcomes was evaluated by questionnaire (1 = excellent, 2 = very good, 3 = good, 4 = fair, 5 = poor, 6 = very poor) and by asking patients whether they would undergo the procedure again. Furthermore, information on patient characteristics, recurrence of dislocation, revision surgery, and other postoperative complications were recorded.
Postoperative x-rays were analyzed concerning intraoperative complications (e.g. fractures or patellar drill hole malpositioning).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were identified through the hospitals database using OPS-Codes for MPFL reconstruction.
Key inclusion criteria (2 listed)
- Patients with MPFL reconstruction and possible accompanying interventions
- Age >18 years
Key exclusion criteria (3 listed)
- Known hereditary connective tissue diseases (e.g. Ehlers-Danlos syndrome)
- Known neurogenic diseases
- Significant further musculoskeletal disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kujala score
Time frame: 24 months postoperative
The Kujala Anterior Knee Pain Scale is a patient reported assessment of patellofemoral disorders that assesses subjective symptoms and functional limitations. The score consists of 13 questions that add up to a total of 100 points. Minimum: 0 (worst), Maximum: 100 (best)
Norwich Patellar Instability Score (NPI Score)
Time frame: 24 months postoperative
The Norwich Patellar Instability Score is a patient reported assessment of patellofemoral instability. The score consists of 19 questions with a special weighting for every question. The results are presented in percent. Range: 0% (best) to 100% (worst)
BANFF Score
Time frame: 24 months postoperative
The Banff Score is a patient reported assessment of patellofemoral disorders that assesses patella instability. The score consists of 23 questions. Minimum: 0 (worst), Maximum: 100 (best)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Derived from this study: PubMed 34633513Horstmann H, Karkosch R, Berg A, Becher C, Petri M, Smith T. The novel dynamic MPFL-reconstruction technique: cheaper and better? Arch Orthop Trauma Surg. 2022 Aug;142(8):2011-2017. doi: 10.1007/s00402-021-04198-z. Epub 2021 Oct 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patellar Luxation and Patellar Instability, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kujala score (time frame: 24 months postoperative). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04438109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2021.