Scaphoid Non-UnionsNCT01419808
Vascularized Versus Non-Vascularized Bone Grafts in Treating Proximal Pole Scaphoid Non Unions
A study testing Vascularized Bone Graft and Non-Vascularized Bone Graft in people with Scaphoid Non-Unions, run by Hand and Upper Limb Clinic, Canada at 1 site in Canada.
Trial summary
The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Scaphoid Non-Unions
- What is being tested?
- Vascularized Bone Graft and Non-Vascularized Bone Graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2007to Jul 2012
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary inclusion criterion is any scaphoid waist or proximal pole non-union in a patient receiving a recommendation for operative treatment. Non-union is defined as <10% bony union across the fracture site on sagittal computerized tomography (CT) after at least 16 weeks of appropriate non-operative treatment or morphologic features on plain x-ray and CT (resorption and sclerosis at the fracture site, significant cyst formation) confirming non-union.
Who cannot join
- radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
- fragmentation of the proximal pole
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hand and Upper Limb Centre, St Joseph's Health Care
London, Ontario, N6A4L6
James H Roth, MD, FRCSC, FACS, 519-646-6050, james.roth@sjhc.london.on.ca
Joy C MacDermid, MScPT, PhD, 519-646-6100 ext. 64636, joy.macdermid@sjhc.london.on.ca
About this study
Official title: Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial
The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Secondary objectives are to examine if there is any difference in the overall rate and time to union, range of motion, grip strength, or complication rates between the two groups.
In addition, this is the first prospective randomized study to directly compare the two techniques. This is also the first study to use standardized methods of assessing union (based on computerized tomography), standardized methods of collecting objective patient data, and utilizing validated patient questionnaires to assess pain and disability.
- Conditions
- Scaphoid Non-Unions
- Being tested
- Vascularized Bone Graft, Non-Vascularized Bone Graft
- Keywords
- Scaphoid, Non-Union, Proximal pole, Bone Graft, Vascularized, Non-Vascularized, PREE
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascularized Bone GraftProcedure or surgery
Vascularized bone graft in the treatment of Scaphoid Non-Union
Non-Vascularized Bone GraftProcedure or surgery
Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions
| Study group | Role | What they receive |
|---|---|---|
| Vascularized Bone Graft | Active comparator | Patients randomized to a vascularized bone graft will undergo a 1, 2-ICRSA vascularized bone graft based upon the 1,2 supra-retinacular vessels as described by Zaidemberg . (9. Zaidemberg C, Siebert JW, Angrigiani C. A new vascularized bone graft for scaphoid nonunion. J Hand Surg. 1991; 16A: 474-478.) Receives: Procedure: Vascularized Bone Graft |
| Non-Vascularized Bone Graft | Active comparator | Patients randomized to the non-vascularized group will undergo trapezoidal bone grafting from the iliac crest as described by Fernandez . (10. Fernandez DL. A technique for anterior wedge-shaped grafts for scaphoid nonunions with carpal instability. J Hand Surg [Am]. 1984 Sep;9(5):733-7.) Receives: Procedure: Non-Vascularized Bone Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Rated Wrist Evaluation
Patients will fill out the patient rated wrist Evaluation Questionnaire
Measured: Change in PRWE score at time of Surgery (day 1) compared to two years post operation.
Secondary outcomes (1)
Objective Measures
- ROM
- Grip Strength
- Dexterity
Measured: Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startSep 2007
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scaphoid Non-UnionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hand and Upper Limb Clinic, Canada
- Sponsor type
- Research network
- Investigators
- Ruby Grewal, MD, FRCSC, Principal investigator, Hand and Upper Limb Centre, St. Joseph's Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419808
- Sponsor's protocol ID
- HULCscaphoid
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 18 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Fan S, Suh N, MacDermid JC, Ross D, Grewal R. Vascularized versus non-vascularized bone grafting for scaphoid nonunion without avascular necrosis: a randomized clinical trial. J Hand Surg Eur Vol. 2023 Jul;48(7):648-653. doi: 10.1177/17531934231158992. Epub 2023 Mar 1.
PubMed 36861269
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascularized vs. Non-vascularized Bone Grafting in the Treatment of Proximal Pole Scaphoid Non Unions: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01419808
- Acronym / sponsor ID
- HULCscaphoid
- Conditions
- Scaphoid Non-Unions
- Keywords
- Scaphoid, Non-Union, Proximal pole, Bone Graft, Vascularized, Non-Vascularized, PREE
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hand and Upper Limb Clinic, CanadaResearch network
- Study start
- Sep 2007
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 18 Aug 2011 (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.
The purpose of this study is to investigate whether treatment of scaphoid non-unions with a vascularized bone grafts improves patient reported pain and disability compared to treatment with a non-vascularized bone graft. Secondary objectives are to examine if there is any difference in the overall rate and time to union, range of motion, grip strength, or complication rates between the two groups.
In addition, this is the first prospective randomized study to directly compare the two techniques. This is also the first study to use standardized methods of assessing union (based on computerized tomography), standardized methods of collecting objective patient data, and utilizing validated patient questionnaires to assess pain and disability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascularized Bone Graft | Active comparator | Procedure: Vascularized Bone GraftPatients randomized to a vascularized bone graft will undergo a 1, 2-ICRSA vascularized bone graft based upon the 1,2 supra-retinacular vessels as described by Zaidemberg . (9. Zaidemberg C, Siebert JW, Angrigiani C. A new vascularized bone graft for scaphoid nonunion. J Hand Surg. 1991; 16A: 474-478.) |
| Non-Vascularized Bone Graft | Active comparator | Procedure: Non-Vascularized Bone GraftPatients randomized to the non-vascularized group will undergo trapezoidal bone grafting from the iliac crest as described by Fernandez . (10. Fernandez DL. A technique for anterior wedge-shaped grafts for scaphoid nonunions with carpal instability. J Hand Surg [Am]. 1984 Sep;9(5):733-7.) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The primary inclusion criterion is any scaphoid waist or proximal pole non-union in a patient receiving a recommendation for operative treatment. Non-union is defined as <10% bony union across the fracture site on sagittal computerized tomography (CT) after at least 16 weeks of appropriate non-operative treatment or morphologic features on plain x-ray and CT (resorption and sclerosis at the fracture site, significant cyst formation) confirming non-union.
Key exclusion criteria (2 listed)
- radiologic evidence of significant scaphoid non-union advanced collapse (SNAC) wrist arthritis
- fragmentation of the proximal pole
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 |
|---|---|---|
| Vascularized Bone GraftVascularized bone graft in the treatment of Scaphoid Non-Union | Procedure or surgery | Vascularized Bone Graft |
| Non-Vascularized Bone GraftNon-Vascularized Bone Graft in the treatment of Scaphoid Non-unions | Procedure or surgery | Non-Vascularized Bone Graft |
Primary outcome
Patient Rated Wrist Evaluation
Time frame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation.
Patients will fill out the patient rated wrist Evaluation Questionnaire
1 secondary outcome
Objective Measures
Time frame: Change in strength, ROM, and Dexterity from time of surgery (day 1) compared to two years post operation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2011.
- Derived from this study: PubMed 36861269Fan S, Suh N, MacDermid JC, Ross D, Grewal R. Vascularized versus non-vascularized bone grafting for scaphoid nonunion without avascular necrosis: a randomized clinical trial. J Hand Surg Eur Vol. 2023 Jul;48(7):648-653. doi: 10.1177/17531934231158992. Epub 2023 Mar 1.
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.
Ruby Grewal, MD, FRCSC principal investigator
Hand and Upper Limb Centre, St. Joseph's Health Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascularized Bone Graft and Non-Vascularized Bone Graft in people with Scaphoid Non-Unions, run by Hand and Upper Limb Clinic, Canada at 1 site in Canada.
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 2 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 18 Aug 2011. 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 Canada. 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?
Contact Ruby Grewal, MD, FRCSC (519-646-6286, ruby.grewal@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Rated Wrist Evaluation (time frame: Change in PRWE score at time of Surgery (day 1) compared to two years post operation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01419808, which also lists 1 linked publication.
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 18 Aug 2011.