New tape could fix unstable kneecaps in Long-Term trial
NCT ID NCT05264389
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing two types of Poly-Tape devices used to rebuild a key ligament in the kneecap. Researchers will follow 59 patients for up to 5 years after surgery to see if the tape helps prevent the kneecap from dislocating again and improves knee function. The goal is to confirm the devices are safe and work well over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Poly-Tape devices (10mm Poly-Tape or 5mm Infinity-Lock Tape)
- What this could lead to
- If successful, this could confirm that Poly-Tape devices are a safe and effective option for repairing the kneecap ligament, helping patients regain stability and function.
- What could go wrong
- This is a small, non-randomized study with only 59 participants, so results may not apply to everyone. There is a risk of re-dislocation or complications like any surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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59 people
The number who actually took part.
- Started
-
Sep 2022
- Expected to finish
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Aug 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who require MPFL reconstruction.
- Ages
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13 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient must be 13 years old or above. Patients who require MPFL reconstruction. Patients willing to participate in the study and have been informed of the nature of the study, agree to its follow-up and have provided written informed consent as approved by the Research Ethics Committee (REC). Exclusion Criteria: These devices should not be used in procedures which bridge, disturb, or disrupt the growth plate in immature patients since they will not elongate as the patient grows. Patients known to be hypersensitive to titanium alloy or polyester. Appropriate tests should be carried out on patients with suspected material sensitivity prior to implantation. Patients with any infections or structural or pathological condition of the bone or soft tissue that would be expected to impair healing or secure fixation. Bone quality should be assessed prior to surgery. Patients who are unable or unwilling to restrict activities to prescribed levels or to follow the rehabilitation instructions during the healing period. Patients for whom the implantation is intended to be non-permanent, since they integrate well with the patient's tissue.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hampshire Hospitals NHS Foundation Trust
Winchester, SO22 5DG, United Kingdom
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James Paget University Hospitals NHS Foundation Trust
Great Yarmouth, NR31 6LA, United Kingdom
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Somerset NHS Foundation Trust
Yeovil, BA21 4AT, United Kingdom
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Tameside and Glossop Integrated Care NHS Foundation Trust
Manchester, OL6 9RW, United Kingdom
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University of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom
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