Tendon InjuriesNCT01014494
Adaprev in Digital Flexor Tendon Repair
A study testing Adaprev in people with Tendon Injuries, run by Renovo at 9 sites in United Kingdom.
Trial summary
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- Adaprev
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- Sep 2009to Dec 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.
Who cannot join
- Subjects with additional complicated injuries
- Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
- Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
- Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
- Subjects with conditions which may delay healing.
- Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
- Females who are pregnant
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites, 9 recruiting
- Recruiting
Mr P Gillespie
Addenbrooke's Hospital, Cambridge, Cambridge, CB2 0QQ
Patrick Gillespie, 01223 274632, Patrick.gillespie@addenbrookes.nhs.uk
- Recruiting
Royal London Hospital, Barts and The London Hospital
London, London, E1 1BB
Kamal El-Ali, 07986 693062, Kamal.El-Ali@bartsandthelondon.nhs.uk
Raj Ragoowansi
- Recruiting
Royal Free Hospital
London, London, NW3 2QG
Donald Dewar, 020 7794 0500 ext. 31302
Donald Dewar
- Recruiting
Chelsea & Westminster Hospital
London, London, SW10 9NH
Mr Chakrabarty, 020 8237 2777 ext. 55490, khchakrabarty@yahoo.com
Beryl De Souza, bds@dr.com
- Recruiting
University Hospital of South Manchester NHS Foundation Trust
Manchester, Greater Manchester, M23 9LT
Miss V C Lees, +44 (0) 161 291 6648
Vivien C Lees
- Recruiting
Mr R Dunn
Salisbury District Hospital, Salisbury, SP2 8BJ
Roderick Dunn, 01722 336262 ext. 3555, sue.dubber@salisbury.nhs.uk
- Recruiting
Mr D Warwick
Southampton General Hospital, Southampton, SO16 6YD
David Warwick, 023 8079 5212, davidjwarwick@btinternet.com
Elaine Hayward, 02380 794 989, elaine.hayward@suht.swest.nhs.uk
- Recruiting
Abertawe Bro Morgannwg University Nhs Trust
Swansea, SA12 7BR
Mr D Boyce, +44 (0) 1792 703722
Mr D Boyce
- Recruiting
Mr F Schreuder
The Lister Hospital, Stevenage, Hertfordshire
Mr Schreuder, 01438 781162, Fred.schreuder@nhs.net
About this study
Official title: A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.
- Conditions
- Tendon Injuries
- Being tested
- Adaprev
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdaprevDevice
Also called Product contains mannose-6-phosphate
Class III Medical Device
| Study group | Role | What they receive |
|---|---|---|
| Active - Adaprev | Experimental | Adaprev (Class III medical device) Receives: Device: Adaprev |
| Standard Care | No intervention | No different treatment to normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.
Measured: 26 weeks post surgery
Secondary outcomes (1)
The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair
Measured: 26 weeks post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionNov 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tendon InjuriesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- John Hutchison, MBBS PhD, Study director, Renovo Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014494
- Sponsor's protocol ID
- RN1008-0083
- Status last verified
- Dec 2010
- First submitted
- 16 Nov 2009
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind Clinical Investigation to Evaluate the Safety, Tolerability, and Preliminary Performance of Adaprev™ in Improving Recovery of Tendon Function in Subjects Undergoing Surgical Repair of Flexor Tendons in Zone II of the Hand
- ClinicalTrials.gov ID
- NCT01014494
- Acronym / sponsor ID
- RN1008-0083
- Conditions
- Tendon Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- RenovoIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 17 Nov 2009 (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.
This study is being undertaken to verify the safety and performance of Adaprev™, a Class III medical device, when administered as a short term implant into the tendon sheath at the time of surgery, on the post-operative function of severed digital tendons. Subjects are randomised to either Adaprev or standard care and attend visits for 26 weeks following surgery. This clinical investigation will recruit 44 subjects in the UK at up to 10 clinical trial sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active - Adaprev | Experimental | Device: AdaprevAdaprev (Class III medical device) |
| Standard Care | No intervention | –No different treatment to normal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects aged 18 years and above with complete division of the Flexor Digitorum Profundus (FDP) tendon in Zone II.
Key exclusion criteria (7 listed)
- Subjects with additional complicated injuries
- Subjects whose flexor tendon repair involves a finger with less than full tendon function prior to the injury requiring repair
- Subjects who are undergoing surgical repair of the severed tendon(s) more than four days after the injury occurred.
- Subjects with a history of clinical significant hypersensitivity to any of the devices, drugs or surgical dressings to be used in this trial.
- Subjects with conditions which may delay healing.
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 |
|---|---|---|
| AdaprevAlso: Product contains mannose-6-phosphateClass III Medical Device | Device | Active - Adaprev |
Primary outcome
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing.
Time frame: 26 weeks post surgery
1 secondary outcome
The secondary endpoint will be an evaluation of the performance of Adaprev™ as measured by the range of motion of the treated finger at twenty six weeks after tendon repair
Time frame: 26 weeks post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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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.
Mr P Gillespie
Addenbrooke's Hospital, Cambridge, United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, United Kingdom
John Hutchison, MBBS PhD study director
Renovo Ltd
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaprev in people with Tendon Injuries, run by Renovo at 9 sites in United Kingdom.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary trial endpoint will be the assessment of safety and local tolerability for a period up to twenty six weeks after dosing. (time frame: 26 weeks post 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 9 Dec 2010.