Total Knee ReplacementGAP-FlexNCT02670499
Study Comparing GAP-Flex to CPM Therapy in Treatment of TKR
A study testing CPM and GAPFLEX in people with Total Knee Replacement, run by Xeras Medical Technologies at 2 sites in United States.
Trial summary
Post Market TKR study Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- CPM and GAPFLEX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Nov 2015to 23 Jun 2017
- Phase
- Interventional
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Minimum age 50 years
- Subject is undergoing total knee replacement
- Subject agrees to comply with the physical therapy regime
Who cannot join
- With a flexure contracture > 10 degrees
- Degree of flexion < 60 degrees pre-procedure or immediately post-procedure
- Severe motion restriction as determined by the investigator
- Severe deformity determined by the investigator
- Taking chronic pain medication for use other than knee pain
- Post surgery hospital stay is > 4 days
Show all 23Show fewer
- Knee disorders other than osteoarthritis
- With fibromyalgia
- Chronic narcotic use as determined by the investigator.
- Have a medical or psychological history that in the opinion of the investigator would make the subject a poor candidate for the study.
- Who need a revision implant
- Who have participated in clinical study within the past 30 days (prior to enrollment) that may affect the outcome of this study
- Amputations below or above knee of non-operated leg
- Weight is >250 pounds and/or morbidly obese (BMI > 40)
- History of blood clots
- Deep vein thrombosis
- Females who are pregnant
- Females who wish to become pregnant during the length of study participation
- Subjects with any of the following post-surgery conditions;
- Screws needed
- Intraoperative identification of a fracture or soft bone
- Admitted to ICU
- Additional procedures (other than TKR) needed for other identified or pre-existing conditions
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nix Orthopaedic Center
San Antonio, Texas, 78205
Orthopaedic Institute
San Antonio, Texas, 78260
About this study
Official title: A Randomized Controlled Multicenter Study Comparing GAP-FLEX to Continuous Passive Motion (CPM) Therapy in Combination With Standard of Care Physical Therapy in Subjects With Total Knee Replacement (TKR)
Post Market TKR study
Read the detailed description
A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR
- Conditions
- Total Knee Replacement
- Being tested
- CPM, GAPFLEX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPMDevice
Also called Continuous Passive Motion Device
Used to aid in recovery from TKR
GAPFLEXDevice
Used to aid in the recovery of TKR
| Study group | Role | What they receive |
|---|---|---|
| GAP-FLEX | Experimental | Study Device will be used up to 6 times per day for up to 6 minutes to aid in the recovery and improve the degree of flexion from TKR Receives: Device: GAPFLEX |
| CPM | Active comparator | Control Device will be used up to 2 hours per day for up to 3 times per day to aid in the recovery and improve the degree of flexion from TKR and be compared to the Study Device Receives: Device: CPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flexion
improvement in week 4 visit degree of flexion measured by Goniometer in the GAP-FLEX group will be compared to the CPM
Measured: Degree of flexion achieved at week 4 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study start18 Nov 2015
- Primary completion7 Feb 2017
- Study completion23 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xeras Medical Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670499
- Sponsor's protocol ID
- GPF2015-01
- Acronym
- GAP-Flex
- Status last verified
- Jun 2017
- First submitted
- 4 Sep 2015
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Multicenter Study Comparing GAP-FLEX to Continuous Passive Motion (CPM) Therapy in Combination With Standard of Care Physical Therapy in Subjects With Total Knee Replacement (TKR)
- ClinicalTrials.gov ID
- NCT02670499
- Acronym / sponsor ID
- GAP-Flex / GPF2015-01
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Xeras Medical TechnologiesIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2015 (actual)
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 23 Jun 2017 (actual)
- First posted
- 1 Feb 2016 (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.
Post Market TKR study
Detailed description
A post-market study to evaluate the safety and effectiveness of the GAP-FLEX device in combination with standard of care physical therapy compared to the standard of care CPM device in combination with standard of care physical therapy in Subjects who have undergone TKR
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GAP-FLEX | Experimental | Device: GAPFLEXStudy Device will be used up to 6 times per day for up to 6 minutes to aid in the recovery and improve the degree of flexion from TKR |
| CPM | Active comparator | Device: CPMControl Device will be used up to 2 hours per day for up to 3 times per day to aid in the recovery and improve the degree of flexion from TKR and be compared to the Study Device |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Minimum age 50 years
- Subject is undergoing total knee replacement
- Subject agrees to comply with the physical therapy regime
Key exclusion criteria (23 listed)
- With a flexure contracture > 10 degrees
- Degree of flexion < 60 degrees pre-procedure or immediately post-procedure
- Severe motion restriction as determined by the investigator
- Severe deformity determined by the investigator
- Taking chronic pain medication for use other than knee pain
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 |
|---|---|---|
| CPMAlso: Continuous Passive Motion DeviceUsed to aid in recovery from TKR | Device | CPM |
| GAPFLEXUsed to aid in the recovery of TKR | Device | GAP-FLEX |
Primary outcome
Flexion
Time frame: Degree of flexion achieved at week 4 visit
improvement in week 4 visit degree of flexion measured by Goniometer in the GAP-FLEX group will be compared to the CPM
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 27 Jun 2017.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPM and GAPFLEX in people with Total Knee Replacement, run by Xeras Medical Technologies at 2 sites 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 3 inclusion and 23 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 27 Jun 2017. 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 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.
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?
Flexion (time frame: Degree of flexion achieved at week 4 visit). 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 27 Jun 2017.