Acute Patella Tendon RupturePhase 4NCT00716508
Surgical Treatment for Acute Patella Tendon Rupture
A Phase 4 study testing Repair with transpatellar tunnels and Repair with suture anchors. in people with Acute Patella Tendon Rupture, run by Emory University at 1 site in United States.
Trial summary
We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Patella Tendon Rupture
- What is being tested?
- Repair with transpatellar tunnels and Repair with suture anchors.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Dec 2009
- Phase
- Phase 4
- 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
Who may be able to join
- Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since the time of injury.
- Age: 18 years old and up.
- Performance status: Patients with no other previous illnesses that prevented them to ambulate normally (without help of devices).
- Informed consent requirements: One person from our research staff will approach the patient after the diagnosis has been made. The diagnosis will be made by the doctor in charge on the patient care based on the medical history, physical exam and image studies (MRI). We will explain the benefits/risks to be part of the study and that they are not obligated to be part of it as part of their care.
Who cannot join
- Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
- Prior other diseases: diseases with systemic collagen deficiencies.
- Infection: Patients with active infection will be disqualified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.
We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.
Read the detailed description
The patella tendon is located in the knee, and is attached to the leg bone and the patella bone (knee cap). The quadriceps muscle (an important tight muscle) attaches to the patella bone and allows for extension and flexion of the leg. Rupture of the patella tendon occurs mainly in people under the age of 40 years old with an active lifestyle. Normally, surgical repair is needed to fix this injury. The widely accepted surgery for this injury consists in drilling 2 holes in the patella bone that are used to anchor the patella tendon in place. This surgery has some complications such as re-rupture of the tendon, breakage of the bone, etc. Some investigators have tried different techniques to avoid these complications with variable results. We want to use 2 anchors in the bone to avoid making holes in the patella bone, decreasing complications and surgical time, and hopefully, allowing for a better surgical repair. We will have 2 arms. One group will have the standard of care technique and the second group will have the anchors technique. We will follow up with our patients after the surgery to record their progress, and complications, if any. We will also have a standardized physical therapy program for consistency and to avoid any problems.
- Conditions
- Acute Patella Tendon Rupture
- Being tested
- Repair with transpatellar tunnels, Repair with suture anchors.
- Keywords
- Patella tendon rupute, suture anchors, repair patella tendon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair with transpatellar tunnelsProcedure or surgery
Repair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella. Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture. Three to four drill holes will then be made through the patella. Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole. The knee will be flexed to 45 degrees. The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella.
Repair with suture anchors.Procedure or surgery
Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery. The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics. Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface. Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery. The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics. Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface. Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner. Receives: Procedure: Repair with suture anchors. |
| B | Active comparator | Repair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella. Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture. Three to four drill holes will then be made through the patella. Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole. The knee will be flexed to 45 degrees. The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella. Receives: Procedure: Repair with transpatellar tunnels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.
Measured: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2008 (estimated)
- Study startSep 2008
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Our PI left our institutions as we could not longer continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Patella Tendon RuptureStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyle Webb, Emory University
- Investigators
- William S Kimmerly, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00716508
- Sponsor's protocol ID
- IRB00010200
- Status last verified
- Sep 2013
- First submitted
- 15 Jul 2008
- Last updated
- 19 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment for Acute Patella Tendon Rupture: a Prospective, Randomized Study Comparing Transpatellar Suture Tunnels Method vs. Suture Anchors.
- ClinicalTrials.gov ID
- NCT00716508
- Acronym / sponsor ID
- IRB00010200
- Conditions
- Acute Patella Tendon Rupture
- Keywords
- Patella tendon rupute, suture anchors, repair patella tendon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Our PI left our institutions as we could not longer continue.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 16 Jul 2008 (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.
We will compare two groups for acute patella tendon repair: one treated with surgical anchors and the second, with transpatellar tunnels.
Detailed description
The patella tendon is located in the knee, and is attached to the leg bone and the patella bone (knee cap). The quadriceps muscle (an important tight muscle) attaches to the patella bone and allows for extension and flexion of the leg. Rupture of the patella tendon occurs mainly in people under the age of 40 years old with an active lifestyle. Normally, surgical repair is needed to fix this injury. The widely accepted surgery for this injury consists in drilling 2 holes in the patella bone that are used to anchor the patella tendon in place. This surgery has some complications such as re-rupture of the tendon, breakage of the bone, etc. Some investigators have tried different techniques to avoid these complications with variable results. We want to use 2 anchors in the bone to avoid making holes in the patella bone, decreasing complications and surgical time, and hopefully, allowing for a better surgical repair. We will have 2 arms. One group will have the standard of care technique and the second group will have the anchors technique. We will follow up with our patients after the surgery to record their progress, and complications, if any. We will also have a standardized physical therapy program for consistency and to avoid any problems.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Repair with suture anchors.Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery. The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics. Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface. Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner. |
| B | Active comparator | Procedure: Repair with transpatellar tunnelsRepair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella. Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture. Three to four drill holes will then be made through the patella. Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole. The knee will be flexed to 45 degrees. The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Stage of Disease: Acute ruptures of the patella tendon, no more than 3 weeks since the time of injury.
- Age: 18 years old and up.
- Performance status: Patients with no other previous illnesses that prevented them to ambulate normally (without help of devices).
- Informed consent requirements: One person from our research staff will approach the patient after the diagnosis has been made. The diagnosis will be made by the doctor in charge on the patient care based on the medical history, physical exam and image studies (MRI). We will explain the benefits/risks to be part of the study and that they are not obligated to be part of it as part of their care.
Key exclusion criteria (3 listed)
- Prior treatment: Patients with chronic patella tendon ruptures (more than 3 weeks).
- Prior other diseases: diseases with systemic collagen deficiencies.
- Infection: Patients with active infection will be disqualified.
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 |
|---|---|---|
| Repair with transpatellar tunnelsRepair with transpatellar tunnels: We will make a small horizontal trough at the inferior pole of the patella. Multiple, braided Krackow sutures will then be placed through the substance of the tendon using no. 5 Fiberwire (Arthrex, Naples FL) suture. Three to four drill holes will then be made through the patella. Using a suture passer, the sutures will then be brought from distal to proximal and tied over the superior pole. The knee will be flexed to 45 degrees. The tendon will be repaired adjacent to the articular surface and not to the anterior surface of the patella. | Procedure or surgery | B |
| Repair with suture anchors.Repair with suture anchors: The insertion points for the three suture anchors will be marked with electrocautery. The anchors will be placed approximately 2 mm from the articulate surface; placing them too superficially may increased the joint reactive force and lead to abnormal patella femora joint mechanics. Pilot holes will be drilled with a 3.2-mm drill bit parallel to the patella, avoiding penetration of the articular surface. Three Suture anchors (Arthrex, Naples FL) will be threaded with two No. 5 Fiberwire (Arthrex, Naples FL) sutures and will be inserted and deployed in the pilot holes in the usual manner. | Procedure or surgery | A |
Primary outcome
Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores.
Time frame: Weeks 0-3, 4-6, 7-8, 12 and 16-24 after surgery:
Results and safety
The study was stopped early (reason given: Our PI left our institutions as we could not longer continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2013.
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.
William S Kimmerly, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Repair with transpatellar tunnels and Repair with suture anchors. in people with Acute Patella Tendon Rupture, run by Emory University at 1 site in United States.
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 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: stopped early, as of the sponsor's last update on 19 Sep 2013. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Our PI left our institutions as we could not longer continue.). Results are not available in the source record.
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?
Outcome measures will include SF 36, Tegner and Lysholm scores, as well as IKDC scores. (time frame: Weeks 0-3, 4-6, 7-8, 12 and 16-24 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 19 Sep 2013.