Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial

• Sponsor: J&M Shuler (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01118715
• Collaborator: (none)
• Enrollment: 128
• Location: 1
• Arms: 2
• Duration (Months): 89
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

Distal radius fractures (DRF) are the most common type of fracture in the human body, and a large proportion of DRFs result in complications. Previously proposed preventive strategies have questionable efficacy and may impose additional risks on the patient. Because many complications secondary to distal radius fractures are associated with excessive swelling, a prophylactic means for edema reduction could dramatically reduce morbidity among this population. A compression glove is a non-invasive, non-pharmacological way to reduce edema. Previous studies have confirmed its utility in edema reduction after hand trauma and among patients with chronic inflammatory conditions, but none have sufficiently investigated the application to patients with distal radius fractures, a population in which this intervention could have a large impact. The investigators propose a randomized controlled trial to evaluate use of a compression glove during recovery among patients who have sustained an unstable distal radius fracture. The investigators hypothesize that patients who wear a compression glove after a distal radius fracture:

• Will experience less edema

• Will demonstrate greater functionality

• Will recover more quickly

• Will have lower incidence rates of carpal tunnel syndrome

• Will have lower incidence rates of complex regional pain syndrome

Condition or Disease	Intervention/Treatment	Phase
Post-traumatic Carpal Tunnel Syndrome; Complex Regional Pain Syndrome; Edema	Device: Compression glove	N/A

Detailed Description

Patients will be recruited from the principle investigator's practice at Athens Orthopedic Clinic. As the only hand and upper-extremity surgeon in the Athens-Clarke county metro area, principle investigator performs the majority of this type of surgery for patients in Athens and surrounding cities. Therefore, the study population should be largely representative of the target population.

Procedures:

1. Patient Identification: Patient presents with distal radius fracture.

2. An x-ray is taken to decide whether the fracture requires surgical stabilization.

3. Unstable distal radius fractures will be based on the following criteria:

4. Radial shortening <5 mm at the DRUJ compared with the contralateral side 2. Radial inclination on the posteroanterior radiographs > 15⁰ 3. Sagittal tilt on the lateral projection between 15⁰ dorsal tilt and 20⁰ volar tilt 4. Intra-articular step-off or gap <2 mm of the radiocarpal joint 5. Articular incongruity <2 mm of the sigmoid notch of the distal radius 2. Screening: Patients whose fracture is unstable will be assessed for eligibility using the aforementioned criteria.

5. Consent and de-identification: Patients who are deemed evaluable based on the eligibility criteria will be asked if they are interested in participating in a research study.

6. Those who are interested will meet with a member of the study team, who will explain the study and answer any questions the patient might have.

7. The participant will be given two (2) copies of the informed consent form and HIPAA authorization form. One copy of each document will be signed and returned to the study team, to be kept in a secure location, and the other copy will be given to the participant for his/her records.

8. Each study participant will be assigned a unique study identification number in order to keep his/her identity anonymous. The participant's name and study ID will be recorded on the first page of the case report form, which is detached and kept in a locked filing cabinet immediately following consent. All subsequent data collection will be recorded on the data collection form at follow-up visits with the principle investigator. Data will be entered into a secure, de-identified database by a member of the study team, using the patient's study ID as an identifier. The database will not contain any information that may be used to identify the patient. 4. Surgery: All fractures will be stabilized by volar plate fixation or closed reduction percutaneous pinning using a distal volar radial locking plate or other appropriate implant. 5. Randomization: To avoid any potential bias on the part of the surgeon, patients will be randomized postoperatively to receive either the investigational (glove) or control (no glove) intervention. Therefore, the surgeon will be blinded to intervention status until after patient enrollment and surgical stabilization. 6. Post-surgery: The wound will be dressed steriley, per standard protocol. Initial sterile cast padding will be placed over sterile dressing. For patients in the investigational group, the compression glove will be applied over cast padding, followed by additional padding and then a splint. Patients in the control group will be dressed identically, with the exception of glove application. The splint will be applied for two weeks post-surgery and removal of the splint and application of a short-arm cast will occur at five weeks post-surgery.

Additional post-surgical procedures are as follows:

1. 2 weeks- splint is removed; glove is taken off for edema measurements (investigational group); short- arm cast is applied b. 5 weeks- short-arm cast is removed; patient can continue to wear compression glove on an as-needed basis; patient is given post-operative exercise handout c. 3 months- patients meet with study physician for routine follow-up visit
2. 6 months- patients meet with study physician for final follow-up visit; once fully healed, patient is given option of having plates removed 7. Therapy: Patients will be given a handout explaining post-operative exercises to be performed at home during recovery.

1. In addition, participants will attend therapy twice weekly, beginning five weeks from surgery. Duration of therapy will be as-needed at the therapist's discretion. Discharge from therapy will be based on the therapist's assessment that the patient has recovered to the extent that they can continue an exercise program at home.

2. Patients who stop coming to therapy prior to discharge will be contacted by the therapists and asked to provide his/her primary reason for not returning. 8. Outcome assessment: outcomes will be assessed at each of four follow-up visits, occurring two weeks, six weeks, three months, and six months from surgery. These coincide with regular post-operative visits, so as to minimize loss to follow-up. Each visit will assess each of the outcome measurements explained in later sections.

Study Design

• Study Type: Interventional
• Actual Enrollment: 128 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Use of Compression Glove to Prevent Complications After Distal Radius Fractures: a Randomized Controlled Trial
• Study Start Date: Apr 1, 2010
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Compression glove Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal.	Device: Compression glove; A compression glove worn during recovery from distal radius fracture
No Intervention: Control Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.

Outcome Measures

Primary Outcome Measures

1. Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS) [2 wks-24 wks]

   Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)

Secondary Outcome Measures

1. Edema [2 wks- 24 weeks]

   Circumference of Wrist/Finger by Glove or No Glove

2. Range of Motion [2 wks-24 wks]

   Count of participants (by group) that were capable or full extension or flexion at each encounter.

3. Grip Strength [5 wks-24 wks]

   Grip strength measured using a hand dynamometer at each visit except @ 2-weeks; grip strength was not measured at 2-weeks because of post-op activity restrictions recommended by the treating physician

4. DASH Score [2 wks- 24 wks]

   Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) is 30-item questionnaire designed to quanitfy functional outcomes of the upper extremity and measure symptoms of pain, physical, emotional, and social domains associated with musculoskeletal disorders of the upper limb. Scores can range from 0-100 with 0 indicating NO disability and 100 indicating extreme disability.

5. Pain on Numerical Rating Scale [2 wks- 24 wks]

   Assessment of pain using a numerical rating scale of 0-10, where 0=no pain and 10=worst possible pain

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or female

• Between the ages of 18-85

• Patients with unstable unilateral distal radius fractures (requiring surgical stabilization)

Exclusion Criteria:

• Pre-existing cases of carpal tunnel syndrome and/or complex regional pain syndrome

• Nerve or tendon laceration

• Decompression of carpal tunnel concomitant with surgical stabilization

• Additional fractures, including carpal fractures, more proximal fractures of the radius, and finger injuries will be excluded from the study (Ulnar styloid and ulnar head and neck fractures will be included)

• Uncontrolled rheumatoid arthritis patients

• Bilateral fractures

• Unable or unwilling to provide written informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Athens Orthopedic Clinic	Athens	Georgia	United States	30606

Sponsors and Collaborators

• J&M Shuler

Investigators

• Principal Investigator: Michael S Shuler, MD, J&M Shuler

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Shuler, Hand and Upper Extremity Specialist, J&M Shuler
• ClinicalTrials.gov Identifier: NCT01118715
• Other Study ID Numbers: DRF-001
• First Posted: May 7, 2010
• Last Update Posted: Nov 4, 2020
• Last Verified: Oct 1, 2020

• Keywords provided by Michael Shuler, Hand and Upper Extremity Specialist, J&M Shuler: distal radius fracture; post-traumatic carpal tunnel syndrome; complex regional pain syndrome; compression glove; edema glove
• Additional relevant MeSH terms: Carpal Tunnel Syndrome; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Radius Fractures

Study Results

Participant Flow

Pre-assignment Detail	The initial protocol had 94 participants. Analysis was run, however, numbers were trending but not significant. Additional participants were then enrolled to increase the power of the study, leading to a larger participant number(128) than the study originally intended to have. There is no intention to continue enrolling subjects.

Arm/Group Title	Compression Glove	Control
Arm/Group Description	Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal. Compression glove: A compression glove worn during recovery from distal radius fracture	Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
Period Title: Overall Study
STARTED	68	60
COMPLETED	68	60
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Compression Glove	Control	Total
Arm/Group Description	Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal. Compression glove: A compression glove worn during recovery from distal radius fracture	Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.	Total of all reporting groups
Overall Participants	68	60	128
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (19.9)	59.6 (15.3)	58.22 (18.00)
Sex: Female, Male (Count of Participants)
Female	57 83.8%	46 76.7%	103 80.5%
Male	11 16.2%	14 23.3%	25 19.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Injured wrist (Count of Participants)
Right	30 44.1%	32 53.3%	62 48.4%
Left	38 55.9%	28 46.7%	66 51.6%
Pain Scale (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.1 (2.7)	6.21 (12.7)	5.17 (2.95)

Outcome Measures

1. Primary Outcome

Title	Incidence of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
Description	Confirmed cases of Post-traumatic Carpal Tunnel Syndrome (CTS) or Complex Regional Pain Syndrome (CRPS)
Time Frame	2 wks-24 wks

Outcome Measure Data

Analysis Population Description

'Number Analyzed' is broken down by group (Glove/No Glove) and time frame (2-24 weeks). The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments.

Arm/Group Title	2 Weeks	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	Count of patients with a new CTS or CRPS diagnosis at 2 weeks post-surgery.	Count of patients with a new CTS or CRPS diagnosis at 5 weeks post-surgery.	Count of patients with a new CTS or CRPS diagnosis at 12 weeks post-surgery.	Count of patients with a new CTS or CRPS diagnosis at 24 weeks post-surgery.
Measure Participants	123	116	100	86
new dx of CTS or CRPS	0 0%	4 6.7%	4 3.1%	0 NaN
no new dx of CTS or CRPS	58 85.3%	52 86.7%	44 34.4%	47 NaN
new dx of CTS or CRPS	0 0%	1 1.7%	2 1.6%	0 NaN
no new dx of CTS or CRPS	65 95.6%	59 98.3%	50 39.1%	39 NaN

2. Secondary Outcome

Title	Edema
Description	Circumference of Wrist/Finger by Glove or No Glove
Time Frame	2 wks- 24 weeks

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.

Arm/Group Title	2 Weeks	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	Wrist or finger circumference measured 2 weeks after surgery.	Wrist or finger circumference measured 5 weeks after surgery.	Wrist or finger circumference measured 12 weeks after surgery.	Wrist or finger circumference measured 24 weeks after surgery.
Measure Participants	99	97	70	56
No Glove - Wrist Circumference	18.09 (1.34)	17.53 (1.36)	16.98 (1.37)	16.74 (1.24)
Glove - Wrist Circumference	17.66 (1.46)	16.98 (1.50)	16.75 (1.60)	17.01 (1.56)
No Glove 1st Finger	6.94 (.61)	6.84 (.59)	6.59 (.56)	6.50 (.44)
Glove 1st Finger	6.61 (.70)	6.38 (.66)	6.57 (.68)	6.62 (.79)
No Glove 2nd Finger	6.77 (.64)	6.67 (.61)	6.37 (.56)	6.28 (.41)
Glove 2nd Finger	6.47 (.72)	6.20 (.70)	6.31 (.73)	6.43 (.83)
No Glove 3rd Finger	6.29 (.58)	6.31 (.62)	5.99 (.52)	5.84 (.41)
Glove 3rd Finger	6.09 (.69)	5.86 (.69)	5.85 (.73)	5.98 (.76)
No Glove 4th Finger	5.71 (.51)	5.82 (.53)	5.58 (.50)	5.45 (.41)
Glove 4th Finger	5.56 (.68)	5.46 (.68)	5.50 (.68)	5.56 (.71)

3. Secondary Outcome

Title	Range of Motion
Description	Count of participants (by group) that were capable or full extension or flexion at each encounter.
Time Frame	2 wks-24 wks

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data. Flexion data missing for 3 subjects and extension data missing for 1 subject at 2 wk visit.

Arm/Group Title	2 Weeks	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	Count of participants with full flexion/extension at 2 weeks	Count of participants with full flexion/extension at 5 weeks	Count of participants with full flexion/extension at 12 weeks	Count of participants with full flexion/extension at 24 weeks
Measure Participants	98	97	70	56
No Glove - Full Flexion	24 35.3%	25 41.7%	32 25%	28 NaN
Glove - Full Flexion	20 29.4%	31 51.7%	34 26.6%	26 NaN
No Glove - Full Extension	45 66.2%	44 73.3%	33 25.8%	29 NaN
Glove - Full Extension	44 64.7%	47 78.3%	35 27.3%	26 NaN

4. Secondary Outcome

Title	Grip Strength
Description	Grip strength measured using a hand dynamometer at each visit except @ 2-weeks; grip strength was not measured at 2-weeks because of post-op activity restrictions recommended by the treating physician
Time Frame	5 wks-24 wks

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.

Arm/Group Title	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	Grip strength measured 5 weeks after surgery	Grip strength measured 12 weeks after surgery	Grip strength measured 24 weeks after surgery
Measure Participants	116	100	86
No Glove	6.83 (6.14)	17.79 (9.17)	20.73 (11.69)
Glove	7.39 (6.04)	18.10 (10.44)	23.45 (10.28)

5. Secondary Outcome

Title	DASH Score
Description	Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) is 30-item questionnaire designed to quanitfy functional outcomes of the upper extremity and measure symptoms of pain, physical, emotional, and social domains associated with musculoskeletal disorders of the upper limb. Scores can range from 0-100 with 0 indicating NO disability and 100 indicating extreme disability.
Time Frame	2 wks- 24 wks

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.

Arm/Group Title	2 Weeks	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	DASH score measured 2 weeks after surgery	DASH score measured 5 weeks after surgery	DASH score measured 12 weeks after surgery	DASH score measured 24 weeks after surgery
Measure Participants	123	116	100	86
No Glove	58.12 (22.11)	39.52 (21.18)	20.51 (17.24)	11.50 (14.28)
Glove	62.14 (19.75)	44.98 (22.30)	16.42 (16.54)	10.32 (14.53)

6. Secondary Outcome

Title	Pain on Numerical Rating Scale
Description	Assessment of pain using a numerical rating scale of 0-10, where 0=no pain and 10=worst possible pain
Time Frame	2 wks- 24 wks

Outcome Measure Data

Analysis Population Description

The overall number of participants analyzed is not consistent with numbers provided in the participant flow module (total participants=128) because not all participants attended all follow-up appointments. In addition, QAQC uncovered several cases of appointment records with missing or invalid data.

Arm/Group Title	2 Weeks	5 Weeks	12 Weeks	24 Weeks
Arm/Group Description	Level of pain reported 2 weeks after surgery	Level of pain reported 5 weeks after surgery	Level of pain reported 12 weeks after surgery	Level of pain reported 24 weeks after surgery
Measure Participants	123	116	100	86
No Glove	2.93 (2.03)	2.42 (2.11)	1.32 (1.61)	.81 (1.06)
Glove	3.24 (2.31)	1.75 (1.57)	1.03 (1.48)	.73 (1.08)

Adverse Events

Arm/Group Title	Compression Glove		Control
Arm/Group Description	Patients in this group have a compression glove incorporated into their splint for 2 weeks post-op, and wear a glove underneath their cast for 3 weeks. The patient then wears the glove at night after cast removal. Compression glove: A compression glove worn during recovery from distal radius fracture		Patients in this group undergo standard recovery procedures. This includes a splint worn for 2 weeks post-op, followed by a short arm cast worn for the next 3 weeks.
All Cause Mortality
	Compression Glove		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Compression Glove		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/60 (0%)
Other (Not Including Serious) Adverse Events
	Compression Glove		Control
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/68 (0%)		0/60 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.