ACL RuptureNCT01138696
Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for Anterior Cruciate Ligament (ACL) Repair
An observational study of ACL Rupture and Replacement, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. Read more about this study
- Who is it for?
- Ages 49 to 75 years
- Conditions the study is for
- ACL Rupture, Replacement
- What is being tested?
- Questionnaires and RX
- How many people
- 80 participants
- Where
- 2 sitesBelgium
- Study dates
- Feb 2010to Jul 2015
- 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 49 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
Who may be able to join
- Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
- Max age: 75
- Min age: 49
- Minimum follow up: 22 years
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Algemeen Stedelijk Ziekenhuis
Aalst
University Hospital Ghent
Ghent
About this study
Official title: Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for ACL Repair
About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.
It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.
- Conditions
- ACL Rupture, Replacement
- Being tested
- Questionnaires, RX
- Keywords
- ACL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
RXOther
X-rays and clinical investigation of the knee 20 years after surgery
| Study group | Role | What they receive |
|---|---|---|
| Stryker Dacron synthetic graft | Not described Receives: Other: Questionnaires; Other: RX | |
| Trevira synthetic graft | Not described Receives: Other: Questionnaires; Other: RX |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury
Pain is measured by the VAS-score. For the evaluation of safety and tolerability the patients fill in the Tegner, Lysholm, IKDC, KOOS and SF-36 questionnaires
Measured: 20 years after surgery
Secondary outcomes (1)
A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.
Measured: 20 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACL RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- René Verdonk, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138696
- Sponsor's protocol ID
- 2009/670
- Status last verified
- Dec 2022
- First submitted
- 22 Apr 2010
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-up of the "Stryker Dacron and Trevira Ligament" for ACL Repair
- ClinicalTrials.gov ID
- NCT01138696
- Acronym / sponsor ID
- 2009/670
- Conditions
- ACL Rupture, Replacement
- Keywords
- ACL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Feb 2010 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 7 Jun 2010 (estimated)
- 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.
About 20 years ago synthetic ligaments were used in orthopaedics / traumatology for the repairing and replacement of injuries of the anterior cruciate ligament. After less than 10 years it appeared that a relatively important number of patients showed complications on the basis of synovitis. The situation of another group of patients on the other hand evolved favourably without complications. The study to focuses on this group of patients and attempts to determine how the replacement without problems ab initio, evolved in the time.
It concerns a group of 57 patients who received an implantation in the UZ Ghent between November 85 and October 87 with the Stryker Dacron ligament and a group of 33 patients who received the Trevira ligament in the ASZ Aalst. The clinical result will be stipulated by means of standardized questionnaires and a clinical examination. The radiological result will be determined by the degree of integrity of the ligament that was implanted at the time. In this way the study could give an idea about the degree in which the technical success of the intervention correlates with the clinical success 20 years later.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stryker Dacron synthetic graft | – | Other: Questionnaires, Other: RX |
| Trevira synthetic graft | – | Other: Questionnaires, Other: RX |
Who may qualify
- Ages
- 49 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
Key inclusion criteria (4 listed)
- Patients that received a Stryker Dacron or Trevira ligament to replace there ACL.
- Max age: 75
- Min age: 49
- Minimum follow up: 22 years
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesKOOS, IKDC, SF-36, Lysholm, Tegner, VAS), | Other | Stryker Dacron synthetic graft, Trevira synthetic graft |
| RXX-rays and clinical investigation of the knee 20 years after surgery | Other | Stryker Dacron synthetic graft, Trevira synthetic graft |
Primary outcome
to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury
Time frame: 20 years after surgery
Pain is measured by the VAS-score. For the evaluation of safety and tolerability the patients fill in the Tegner, Lysholm, IKDC, KOOS and SF-36 questionnaires
1 secondary outcome
A clinical and radiographical evaluation of the knee after implantation of a synthetic ligament.
Time frame: 20 years after surgery
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 15 Dec 2022.
- website University Hospital GhentLink provided by the sponsor.
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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.
René Verdonk, MD, PhD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACL Rupture and Replacement, run by University Hospital, Ghent at 2 sites in Belgium.
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 4 inclusion and 0 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 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
to determine the evolution in pain, safety and tolerability of replacement of anterior cruciate ligament (ACL) after trauma or injury (time frame: 20 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2022.